scholarly journals Slip-resistant footwear to reduce slips among health-care workers: the SSHeW RCT

2021 ◽  
Vol 9 (3) ◽  
pp. 1-150
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Michael Zand ◽  
Gillian Frost ◽  
Mark Liddle ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Confidence Interval ◽  
Incidence Rate ◽  
Health Research ◽  
Incidence Rate Ratio ◽  
Intervention Group ◽  
Health And Safety ◽  
Clinical Effectiveness ◽  
Public Health Research ◽  
Control Group

Background In Great Britain, 100,000 injuries due to slips, trips and falls on the level (as opposed to falls from a height, e.g. a ladder) occur in the workplace each year. They are the most common cause of non-fatal injury in the workplace, accounting for 30% of all those injuries reported to the Health and Safety Executive. Nearly 1 million working days are lost because of slips, trips and falls each year. Objectives To assess the clinical effectiveness and cost-effectiveness of 5-star, GRIP-rated, slip-resistant footwear in preventing slips in the workplace compared with usual footwear. Design A two-arm, multicentre, randomised controlled trial with an economic evaluation and qualitative study. Setting Seven NHS trusts in England. Participants NHS staff aged ≥ 18 years, working at least 22.5 hours per week in clinical, general or catering areas who owned a mobile phone. Staff required to wear protective footwear were excluded. Interventions Intervention participants were offered 5-star, GRIP-rated, slip-resistant footwear. The waiting list control group were asked to wear their usual work shoes for the duration of the study and were offered the trial footwear at the end of their participation. Main outcome measures The primary outcome was the incidence rate of self-reported slips in the workplace over 14 weeks. Secondary outcomes included the incidence rate of falls either resulting from a slip or not resulting from a slip, proportion of participants reporting a slip, fall or fracture, time to first slip and fall, health-related quality of life and cost-effectiveness. Results A total of 4553 eligible NHS staff were randomised (2275 to the intervention arm and 2278 to the control arm). In total, 6743 slips were reported [2633 in the intervention group (mean 1.16 per participant, range 0–36 per participant) and 4110 in the control group (mean 1.80 per participant, range 0–83 per participant)]. There was a statistically significant reduction in the slip rate in the intervention group relative to the control group (incidence rate ratio 0.63, 95% confidence interval 0.57 to 0.70; p < 0.001). Statistically significant reductions were observed in falls from a slip (incidence rate ratio 0.51, 95% confidence interval 0.28 to 0.92; p = 0.03), the proportion of participants who reported a slip (odds ratio 0.58, 95% confidence interval 0.50 to 0.66; p < 0.001) or fall (odds ratio 0.73, 95% confidence interval 0.54 to 0.99; p = 0.04) and the time to first slip (hazard ratio 0.73, 95% confidence interval 0.67 to 0.80; p < 0.001). Half of the intervention participants wore the shoes all the time at work. Incremental cost per quality-adjusted life-year in the base case was £38,900 from the NHS perspective and –£60,400 (i.e. cost saving) from the societal perspective. Limitations This was an unblinded trial in which outcome data were participant self-reported, which may have led to inaccuracies in the reported slip data. Exposure to the trial footwear was lower than hoped. Conclusions The offer and provision of 5-star, GRIP-rated footwear reduced slips in the workplace, was acceptable to participants and could be cost-effective. Future work Replication of the study within other settings may be required to evaluate the clinical effectiveness and cost-effectiveness in other environments settings, such as catering and factories. Trial registration Current Controlled Trials ISRCTN33051393. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 9, No. 3. See the NIHR Public Journals Library website for further project information. The Health and Safety Executive provided some research costs.

scholarly journals Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

2017 ◽  
Vol 21 (24) ◽  
pp. 1-198 ◽  
Author(s):  
Sarah Cockayne ◽  
Sara Rodgers ◽  
Lorraine Green ◽  
Caroline Fairhurst ◽  
Joy Adamson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Incidence Rate ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Falls Prevention ◽  
Randomised Controlled

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

scholarly journals Health impacts of environmental and social interventions designed to increase deprived communities’ access to urban woodlands: a mixed-methods study

2019 ◽  
Vol 7 (2) ◽  
pp. 1-172 ◽  
Author(s):  
Catharine Ward Thompson ◽  
Eva Silveirinha de Oliveira ◽  
Sara Tilley ◽  
Aldo Elizalde ◽  
Willings Botha ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Social Cohesion ◽  
Health Research ◽  
Intervention Group ◽  
Health Impacts ◽  
Control Group ◽  
Natural Environments ◽  
Post Intervention

BackgroundContact with natural environments can bring health benefits, but research is lacking on how changes in access to natural environments might improve health, especially for deprived populations.ObjectiveTo evaluate the health impacts of woodland environment interventions intended to increase communities’ engagement with these woodlands.DesignA prospective study of Forestry Commission Scotland’s Woods In and Around Towns (WIAT) programme in deprived communities to enhance public access to natural environments. The study investigated the impact that WIAT had on community-level mental health over time.SettingThree intervention and three control woodland sites, and associated communities within 1.5 km of the woodlands, located in central Scotland and eligible for WIAT support.ParticipantsA core community survey was administered at each site in three waves, at baseline and after each phase of intervention (n = 5460, panel A). The completed survey contained a nested longitudinal cohort (n = 609, panel B). Community members also undertook 6-monthly environmental audits at all sites (n = 256) and participated in post-intervention focus groups (n = 34).InterventionsPhase 1 involved physical changes to the woodlands, including footpaths, entrances and vegetation. Phase 2 involved community engagement events promoting woodland use.Main outcome measuresThe primary outcome was the Perceived Stress Scale (PSS). Other health measures included health-related quality of life (HRQoL) EuroQol-5 Dimensions (EQ-5D), physical activity (PA) [International Physical Activity Questionnaire (IPAQ)], connectedness to nature [Inclusion of Nature in Self (INS) scale] and social cohesion.ResultsThe PSS scores significantly increased in the intervention group and marginally decreased in the control group. Multilevel regression models showed a differential impact between the intervention and the control at survey wave 3 in panel A [B(unstandardised coefficient) 3.58, 95% confidence interval (CI) 2.85 to 4.31;p < 0.001] and in panel B [B3.03, 95% CI 1.54 to 4.52;p < 0.001]. Using the same analytical approach, no significant change in HRQoL was associated with the intervention. Economic assessment included an illustrative cost–utility analysis and a cost–consequences analysis. The differential in stress between the intervention group and the control group was lower or non-significant in those who visited ‘nature’ in the previous year [panel A,B1.9, 95% CI 0.8 to 3.0;p < 0.001; panel B,B0.64, 95% CI –1.60 to 2.88;p = 0.57]. The IPAQ score showed a positive association with the intervention for moderate levels of PA [panel B,B559.3, 95% CI 211.3 to 907.2;p = 0.002] and overall PA [panel B,B861.5, 95% CI 106.5 to 1616.4;p = 0.025]. The intervention was also associated with increased nature connectedness and social cohesion by wave 3 – significant for panel A only. Qualitative and quantitative evidence showed that interventions increased the perceived quality of the woodland environment and enhanced its enjoyment for different activities, but the increase in use of natural environments post intervention was only 6% (panel B).LimitationsThis study was limited to three intervention sites. External factors may be the primary influence on health outcomes.ConclusionsThe WIAT interventions did not improve community-level health within 6 months of completion, and hence there was no basis for demonstrating cost-effectiveness. However, the WIAT interventions are low cost (average £11.80 per person in the eligible population) and have potential for cost-effectiveness, if health benefits were found in the longer term.Future workUsing routinely collected data to consider a whole-programme evaluation is recommended.FundingThe National Institute for Health Research Public Health Research programme.

scholarly journals Application of closed kinematic chain exercises with eccentric and strength exercises for the shoulder injuries prevention in student rock climbers: a randomized controlled trial

2021 ◽  
Vol 23 (2) ◽  
Author(s):  
Serhii Kozin ◽  
Marian Cretu ◽  
Zhanneta Kozina ◽  
Andrii Chernozub ◽  
Olena Ryepko ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Intervention Group ◽  
Injury Rate ◽  
Kinematic Chain ◽  
Control Group ◽  
Fisher Exact Test ◽  
Shoulder Injuries ◽  
Strength Exercises

Purpose: The aim of this work to determine the influence of a program containing exercises in a closed kinematic chain, eccentric and strength exercises on injuries of students – rock climbers. Methods: Participants in this study were 84 male amateur climbing students, aged 18–19, 40 athletes were in the intervention group and 44 in the control group. In the intervention group, the program for the injuries prevention has been stalled. The program included exercises that are performed in a closed kinematic chain in combination with exercises that are performed in eccentric mode and strength exercises. We determined the Incidence rate ratio and confidence intervals. The Incidence rate ratio was determined by the by Fisher exact test. Results: The significant influence of the developed program on the reduction of injuries among the athletes of the intervention group was revealed. Injury rate per 1000 AEs recorded of all shoulder injuries in the control group was 3.182, in the intervention group was 0.5, P < 0.001. The incidence rate ratio for mild shoulder injuries was 0.861 (0.737; 1.007). The incidence rate ratio for moderate shoulder injuries was 0.862 (0.751; 0.990; P = 0.039). The incidence rate ratio for severe shoulder injuries was 0.864 (0.768; 0.971; P = 0.017). Conclusions: The use of exercises in a closed kinematic chain and exercises in an eccentric mode reduces the Incidence rate ratio of shoulders among students – amateur climbers. The incidence rate ratio decreases in the intervention group for mild, moderate, and severe shoulder injuries.

scholarly journals SSHeW study protocol: does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (11) ◽  
pp. e026023 ◽  
Author(s):  
Sarah Cockayne ◽  
Caroline Fairhurst ◽  
Gillian Frost ◽  
Catherine Hewitt ◽  
Mark Liddle ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Incidence Rate ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Hospital Environment ◽  
Control Group ◽  
Dress Code ◽  
Randomised Controlled

IntroductionSlips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments.Methods and analysisA two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance.Ethics and disseminationThis protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants.Trial registration numberISRCTN33051393; Pre results.

A Randomized Controlled Study of the Effectiveness of Electrophysiological Monitoring of Dexmedetomidine in Patients with Brain Damage of Various Origins

2020 ◽  
Vol 75 (5) ◽  
pp. 490-499
Author(s):  
Yuri Y. Kiryachkov ◽  
Marina V. Petrova ◽  
Bagautdin G. Muslimov ◽  
Sergey A. Bosenko ◽  
Mikhail M. Gorlachev
Keyword(s):  
Intervention Group ◽  
Clinical Effectiveness ◽  
Protective Role ◽  
Digital Data ◽  
Controlled Study ◽  
Control Group ◽  
Average Dose ◽  
Autonomic Nervous System Dysfunction ◽  
Sympathetic Hyperactivity ◽  
Starting Dose

Background.At the same time, the main effect of the use of this drug is the elimination of the autonomic nervous system dysfunction and sympatholysis. It seems important to search for a method of indications and selection of a dose of dexmedetomidine in intensive care.Aims to improve the clinical effectiveness of the electrophysiological navigation of the prolonged use of dexmedetomidine in patients with brain pathology of various origins.Methods.The study included 83 patients 2050 days after the traumatic brain injury, anoxic damage; consequences of acute disorders of cerebral. 37 patients comprised the 1st intervention group with a clinical course of dexmedetomidine (male 28; female 9; average age 49.62.3 years) and 46 patients comprised the 2nd control group without pharmacological correction with dexmedetomidine (male 23; female 23, average age 512.5 years). Criteria for the inclusion of prolonged infusion of the drug dexmedetomidine (Orion Pharma, Finland) are based on heart rate variability (HRV) indicators characteristic of sympathetic hyperactivity, the target task of titration of doses of dexmedetomidine served as the parameters for achieving normal HRV indicators, the appearance of parasympathetic hyperactivity served as the basis for reducing the dosage of the drug or stopping it of application. HRV parameters were recorded before dexmetomedine infusion-initially, on 13; 45; 910; 1520 days of drug administration.Results.The starting dose of dexmedetomidine with sympathetic hyperactivity in patients was 0.12 to 0.24 g.kg1.hr1(average dose 0.160.01; total 200 mg/day). According to digital data from HRV, the effective dose of dexmedetomidine ED50 was 0.260.03 g.kg1.hr1(total daily 353.835.1 g) and was achieved on day 910 using dexmedetomidine.Conclusions.The protective role of dexmedetomidine with correction of sympathetic hyperactivity based on electrophysiological navigation according to the HRV is reliable in the following indicators: The improvement of consciousness; a significant decrease in the incidence of distress lung syndrome; septic shock; mortality.

scholarly journals Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ayla S. Turan ◽  
◽  
Leon M. G. Moons ◽  
Ramon-Michel Schreuder ◽  
Erik J. Schoon ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
The Netherlands ◽  
Endoscopic Mucosal Resection ◽  
Intervention Group ◽  
Proximal Colon ◽  
Control Group ◽  
Colon Polyps ◽  
Delayed Bleeding ◽  
Randomized Controlled ◽  
Mucosal Resection

Abstract Background Endoscopic mucosal resection (EMR) for large colorectal polyps is in most cases the preferred treatment to prevent progression to colorectal carcinoma. The most common complication after EMR is delayed bleeding, occurring in 7% overall and in approximately 10% of polyps ≥ 2 cm in the proximal colon. Previous research has suggested that prophylactic clipping of the mucosal defect after EMR may reduce the incidence of delayed bleeding in polyps with a high bleeding risk. Methods The CLIPPER trial is a multicenter, parallel-group, single blinded, randomized controlled superiority study. A total of 356 patients undergoing EMR for large (≥ 2 cm) non-pedunculated polyps in the proximal colon will be included and randomized to the clip group or the control group. Prophylactic clipping will be performed in the intervention group to close the resection defect after the EMR with a distance of < 1 cm between the clips. Primary outcome is delayed bleeding within 30 days after EMR. Secondary outcomes are recurrent or residual polyps and clip artifacts during surveillance colonoscopy after 6 months, as well as cost-effectiveness of prophylactic clipping and severity of delayed bleeding. Discussion The CLIPPER trial is a pragmatic study performed in the Netherlands and is powered to determine the real-time efficacy and cost-effectiveness of prophylactic clipping after EMR of proximal colon polyps ≥ 2 cm in the Netherlands. This study will also generate new data on the achievability of complete closure and the effects of clip placement on scar surveillance after EMR, in order to further promote the debate on the role of prophylactic clipping in everyday clinical practice. Trial registration ClinicalTrials.gov NCT03309683. Registered on 13 October 2017. Start recruitment: 05 March 2018. Planned completion of recruitment: 31 August 2021.

scholarly journals Effectiveness and cost-effectiveness of an optimized process of providing assistive technology for impaired upper extremity function: Protocol of a prospective, quasi-experimental non-randomized study (OMARM)

2021 ◽  
pp. 1-14
Author(s):  
Uta Roentgen ◽  
Loek van der Heide ◽  
Ingrid E.H. Kremer ◽  
Huub Creemers ◽  
Merel A. Brehm ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Assistive Technology ◽  
Upper Extremity ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Full Potential ◽  
Extremity Function ◽  
Quasi Experimental ◽  
Upper Extremity Function

BACKGROUND: Impaired upper extremity function due to muscle paresis or paralysis has a major impact on independent living and quality of life (QoL). Assistive technology (AT) for upper extremity function (i.e. dynamic arm supports and robotic arms) can increase a client’s independence. Previous studies revealed that clients often use AT not to their full potential, due to suboptimal provision of these devices in usual care. OBJECTIVE: To optimize the process of providing AT for impaired upper extremity function and to evaluate its (cost-) effectiveness compared with care as usual. METHODS: Development of a protocol to guide the AT provision process in an optimized way according to generic Dutch guidelines; a quasi-experimental study with non-randomized, consecutive inclusion of a control group (n= 48) receiving care as usual and of an intervention group (optimized provision process) (n= 48); and a cost-effectiveness and cost-utility analysis from societal perspective will be performed. The primary outcome is clients’ satisfaction with the AT and related services, measured with the Quebec User Evaluation of Satisfaction with AT (Dutch version; D-QUEST). Secondary outcomes comprise complaints of the upper extremity, restrictions in activities, QoL, medical consumption and societal cost. Measurements are taken at baseline and at 3, 6 and 9 months follow-up.

scholarly journals Japanese health and safety information for overseas visitors: protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mariko Nishikawa ◽  
Masaaki Yamanaka ◽  
Akira Shibanuma ◽  
Junko Kiriya ◽  
Masamine Jimba
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Safety Information ◽  
Intervention Group ◽  
Health And Safety ◽  
Trial Registration ◽  
Control Group ◽  
Internet Portal ◽  
Randomized Controlled

Abstract Background Before the COVID-19 pandemic occurred in January 2020, the number of overseas visitors to Japan had increased threefold over the last decade. To minimize the risk of health problems, visitors should be able to access information on the health care systems of the places they visit. Most short-term overseas visitors are young adults. Although they are not very likely to get sick from noncommunicable diseases, they are at high risk for injury and often experience stomach ailments, fever, or nausea when travelling. The objective of this study is to evaluate culturally and linguistically appropriate health information on preventive health behaviours and the health care system in Japan. We will examine the level of satisfaction of overseas visitors to Japan with health care-related educational materials using a five-minute digital game named Sa-Chan Japan. Methods Our study is a randomized controlled trial (RCT). We will assess both satisfaction and motivation before, during, and after the interventions and examine the changes over time. The intervention group will comprise overseas visitors who will view and answer questions in an animation named Sa-Chan Japan. The control group will comprise overseas visitors who will watch an English digital animation named Mari Info Japan. We will recruit 1002 participants through the Macromill Internet portal. We will contact overseas visitors who have either visited or wish to visit Japan from the United Kingdom, United States, and Australia. The participants will fill out a self-administered questionnaire online in the first quarter of 2021. We will determine the participants’ levels of satisfaction with the CSQ-8 (8-item Client Satisfaction Questionnaire). We will analyse the median score of the overseas visitors with both the Wilcoxon rank-sum and the Wilcoxon signed-rank tests. Our protocol of randomized controlled trials follows the SPIRIT guidelines. Discussion Our research will utilize unique digital education strategies in a game that promotes health and safety among overseas visitors to Japan. We believe the results of this study will be useful in overcoming the current challenges regarding pretravel health requirements for overseas visitors worldwide. Trial registration Version 1 of this trial was registered in the UMIN-CTR (University Hospital Medical Information Network Center Clinical Trials Registry), and the trial registration data are available on UMIN000042483, November 17, 2020.

scholarly journals Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour
Keyword(s):  
Mental Health ◽  
Confidence Interval ◽  
Group Counseling ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
The Mean ◽  
And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

scholarly journals Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

2019 ◽  
Vol 7 (20) ◽  
pp. 1-136
Author(s):  
Lynne Callaghan ◽  
Tom P Thompson ◽  
Siobhan Creanor ◽  
Cath Quinn ◽  
Jane Senior ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Health Research ◽  
Pilot Trial ◽  
Well Being ◽  
Public Health Research ◽  
Scale Scores ◽  
Mental Well Being ◽  
Health And Well Being ◽  
Full Trial

Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1 : 1 individual allocation to receive support from a health trainer and usual care or usual care alone, with a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

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