Improvements in Health-Related Quality of Life, Cardio-Metabolic Health, and Fitness in Postmenopausal Women After an Exercise Plus Health Promotion Intervention: A Randomized Controlled Trial

2017 ◽  
Vol 14 (5) ◽  
pp. 336-343 ◽  
Author(s):  
Mercedes Vélez-Toral ◽  
Débora Godoy-Izquierdo ◽  
Nicolás Mendoza Ladrón de Guevara ◽  
Carlos de Teresa Galván ◽  
Alberto Salamanca Ballesteros ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Metabolic Health ◽  
Metabolic Status ◽  
Control Group ◽  
Randomized Controlled ◽  
Health And Fitness ◽  
Mental Well Being

Background:This study explored multidimensional outcomes that were derived from the adherence to regular exercise among previously sedentary postmenopausal 45 to 64 years old women who engaged in a ~20-week exercise program.Methods:A randomized controlled trial with between-group (intervention and control women) and within-subject measures (baseline, postintervention, and 3-month and 12-month follow-ups) was conducted. HRQoL and several indicators of cardio-metabolic status and fitness were assessed.Results:After the intervention, the participants experienced a positive change in their short and long-term physical and mental health, with significant enhancements in several HRQoL dimensions, particularly mental well-being (23.3% of change) and menopause-related health and subdomains (17.0% of change) (P < .01). Improvements were maintained or continued (eg, mental well-being) overtime. These outcomes were accompanied by significant improvements in cardio-metabolic status and fitness, including weight, BMI, cardio-respiratory fitness and flexibility (up to 16.2% of change, P < .05). After the intervention, the intervention group exhibited better HRQoL than the control group at each of the measurement phases. Between-group differences were also observed for some indicators of cardiovascular health and flexibility.Conclusions:Our findings add evidence on the association of positive outcomes on HRQoL with improvements in cardio-metabolic health and fitness status after the adoption of an active lifestyle.

scholarly journals A randomized controlled trial of a specific reminiscence approach to promote the well-being of nursing home residents with dementia

2004 ◽  
Vol 16 (1) ◽  
pp. 33-49 ◽  
Author(s):  
Claudia K. Y. Lai ◽  
Iris Chi ◽  
Jeanie Kayser-Jones
Keyword(s):  
Randomized Controlled Trial ◽  
Nursing Home ◽  
Repeated Measures ◽  
Comparison Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled

Background: To date, no firm conclusions can be reached regarding the effectiveness of reminiscence for dementia. Researchers have emphasized that there is an urgent need for more systematic research in the area.Objective and Method: A single-blinded, parallel-groups (one intervention, one comparison, and one no-intervention group) randomized controlled trial (RCT) was adopted to investigate whether a specific reminiscence program leads to higher levels of psychosocial well-being in nursing home residents with dementia. The intervention adopted a life-story approach, while the comparison group provided friendly discussions to control for any changes in outcome as a result of social contacts and attention. The Social Engagement Scale (SES) and Well-being/Ill-being Scale (WIB) were the outcome measures used. The outcomes of the groups were examined with reference to the baseline (T0), immediately (T1), and six weeks (T2) after intervention. The final sample had 101 subjects (control group: n=30; comparison group: n=35; intervention group: n=36). Using multivariate analysis with repeated measures, no significant differences in outcome were found between groups at either T1 or T2. Wilcoxon signed rank tests were performed for each group comparing outcomes between T1 and T0, T2 and T1, and T2 and T0. Significant differences were observed in the intervention group when comparing T1 and T0 WIB (p=.014), but not for the other groups.Conclusion: Although the intervention did not lead to significant differences between the three groups over time, there was a significant improvement in psychosocial well-being for the intervention group.

scholarly journals Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Ernst Bohlmeijer ◽  
Jannis Kraiss ◽  
Marijke Schotanus-Dijkstra ◽  
Peter ten Klooster
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Sensitivity Analyses ◽  
Control Group ◽  
Multiple Mediation ◽  
Randomized Controlled ◽  
Gratitude Intervention ◽  
Mental Well Being ◽  
Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

scholarly journals Comparing The Effects of Self-Selected Music Versus Predetermined Music On Patient Anxiety Prior To Gynaecological Surgery: The MUANX Randomized Controlled Trial

2021 ◽  
Author(s):  
Danielle Reynaud ◽  
Nicolas Bouscaren ◽  
Victorine Lenclume ◽  
Malik Boukerrou
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Gynaecological Surgery ◽  
Patient Anxiety ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).Methods: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The mean age of the 171 evaluated patients was 41.5 years (SD=10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M=38.8, SD=11.9) and the intervention group (M=39.0, SD=13.1). After the music session, this score had significantly decreased in both the control group (M= -7.2, SD=9.0) and the intervention group (M=-5.5, SD=6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.Conclusion: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registration The MUANX trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

scholarly journals The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Maryam Behrouian ◽  
Tahereh Ramezani ◽  
Mahlagha Dehghan ◽  
Abdoreza Sabahi ◽  
Batool Ebrahimnejad Zarandi
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Psychological Traits ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Mean

Abstract Background Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. Methods The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner–Davidson resilience scale before and one month after the intervention. Results The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). Conclusions According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients’ caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116

scholarly journals BRAIN FITNESS INTERVENTION ON KNOWLEDGE AND WORRIES ABOUT ALZHEIMER’S: A RANDOMIZED CONTROLLED TRIAL

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S1-S1
Author(s):  
Kaipeng Wang ◽  
Fei Sun ◽  
Qiuling An ◽  
Yanfei Han ◽  
Yi Zhou
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Tai Chi ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Brain Fitness

Abstract As one of the world’s fastest aging countries, China’s growing prevalence of Alzheimer’s and related dementias (ADRD) poses concerns among older adults. Lack of knowledge about ADRD and excessive worries about ADRD can cause cumulative stress and threaten physical and psychological well-being of older adults. We conducted a randomized controlled trial to examine the effectiveness of a Brain Fitness Intervention (BFI) on the knowledge and worries about Alzheimer’s at three senior residential care facilities in China. Ninety older adults aged 60 and above underwent randomization. Fifty participants in the intervention group received eight weekly BFI sessions, including Tai Chi exercise, experiential learning, and group discussions. The primary outcomes were the changes from baseline to Week 8 in the scores on the ADRD knowledge scale (ranging 5–50) and worry scale (ranging 5–45). Twenty-seven participants withdrew from the study. Intent-to-treat analysis showed that the estimated mean change in knowledge on ADRD was 4.26 in the treatment group and -1.52 in the control group (p &lt; 0.001). The estimated mean change in worries about ADRD was -10.25 in the treatment group and -2.9 in the control group (p &lt; 0.001). Results remained robust in sensitivity analysis adjusting for study sites and baseline characteristics. Heterogeneity analysis showed that the treatment effect became stronger with the increase of age. Findings support the effectiveness of BFI in increasing ADRD knowledge and reducing worries among Chinese older adults. Future trials with larger sample sizes will be needed for more conclusive results.

scholarly journals Effectiveness of Pediatric Teleconsultation to Improve Skin Conditions in Infants and to Reduce Parenting Stress in Mothers: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Tomohisa Ando ◽  
Rintaro Mori ◽  
Kenji Takehara ◽  
Mari Asukata ◽  
Shuichi Ito ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Atopic Dermatitis ◽  
Parenting Stress ◽  
Short Form ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Stress Index ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Electronic health (eHealth) for infants and mothers is a current focus of attention, but its effectiveness has rarely been examined in Japan. For infants, skin problems, including atopic dermatitis (AD), which is known to lead to other allergic diseases, is one of the most common conditions. For mothers, parenting stress, which adversely affects mothers’ and children’s well-being, is one of the biggest problems in the postpartum period; this requires a national solution in Japan. OBJECTIVE To evaluate the effectiveness of pediatric teleconsultation for preventing atopic dermatitis in infants and reducing parenting stress in mothers in Japan. METHODS The study was an open-label, randomized, parallel-armed controlled trial. In total, 318 pairs of infants and mothers in Yokohama City Sakae Ward in Japan were recruited when they submitted birth cards to the ward, received the explanation, and completed online informed consent on the website for this trial. Eligible pairs of infant and mother were randomly assigned to the intervention group (n=140) or the control group (n=138). Participants in both the intervention and control groups received routine postnatal care from the local government services. In addition, participants in the intervention group had the option to use combined pediatric services with teleconsultation and email newsletters without any charge from the date of registration until the infant was 4 months of age. Primary outcomes were (i) the prevalence of AD in infants diagnosed based on the United Kingdom Working Party’s criteria; and (ii) parenting stress and mental status in mothers, assessed using the Parenting Stress Index-Short Form (PSI-SF) and General Health Questionnaire-12 (GHQ-12). Data were collected via the ward office staff and researcher at the 4-month checkup. RESULTS The prevalence of AD in infants was significantly lower in the intervention group than in the control group at the 4-month checkup (20% vs. 33%, P=.03; relative risk ratio, 0.614 [95% confidence interval, 0.406 to 0.927]). No significant differences were observed in the PSI-SF and GHQ-12 scores between the two groups. CONCLUSIONS This is the first randomized controlled trial demonstrating that a combined pediatric service with teleconsultation and email newsletters was effective in reducing the prevalence of AD in infants. Pediatric eHealth will become a new strategy for preventing AD. CLINICALTRIAL UMIN000029774; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034022

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

Sign in / Sign up

Export Citation Format

Share Document