The effect of play-based occupational therapy on symptoms and participation in daily life activities in children with cancer: A randomized controlled trial

Introduction This study aimed to investigate the effect of play-based occupational therapy on symptoms and participation in daily life activities in hospitalized children with cancer undergoing chemotherapy. Method A total of 25 children (mean age = 9.28 ± 0.95 years, range = 7–12 years) with cancer undergoing chemotherapy were enrolled and randomly assigned to a play-based occupational therapy group ( n = 12) or control group ( n = 13). The intervention group received eight 1-hour play-based occupational therapy sessions, and the control group received traditional occupational therapy services. Participation in daily life activities, therapy-related symptoms, pain, anxiety, and fatigue were evaluated. Results Total mean scores of participation in daily life activities in the intervention group in the diversity of activities ( p = 0.001, d = 1.39), intensity of participation ( p = 0.001, d = 1.86), with whom done ( p = 0.005, d = 1.22), enjoyment ( p = 0.003, d = 1.33), and parents’ satisfaction ( p = 0.003, d = 1.33) were significantly higher than the control group. Symptoms decreased in both groups; however, this trend had a significant difference in the intervention group for the therapy-related symptom checklist ( p = 0.001, d = 1.68), pain ( p = 0.001, d = 1.61), anxiety ( p = 0.001, d = 1.58), and fatigue ( p = 0.002, d = 1.39) scores. Conclusion A 2-week course of inpatient play-based occupational therapy is an effective approach in the reduction of cancer symptoms, therapy-related symptoms, and the participation facilitation, of children with cancer in daily life activities.

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Home-based Palliative Intervention to Improve Quality of Life in Children with Cancer: A Randomized Controlled Trial

10.21203/rs.2.18923/v1 ◽

2019 ◽

Author(s):

Murti Andriastuti ◽

Pricilia G Halim ◽

Elnino Tunjungsari ◽

Dwi P Widodo

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Children With Cancer ◽

Randomized Controlled ◽

Home Based ◽

Significant Difference

Abstract Background: In these last few years, an integrated approach between palliative care (PC) and chronic and/or life-threatening conditions care have been widely used. Home-based PC service is developed to meet the needs of the patients at home, but hasn’t been applied widely. This study is aimed to determine the benefit of integrated home-based PC in the quality of life (QOL) and symtomps intensity of Indonesian children with malignancies. Method: A randomized controlled trial to compare the quality of life between patients who were given PC (a 3-month home visit) and those who were not (intervention vs control group) was conducted, each group containing 30 children with cancer aged 2-18 years old who were consulted to palliative team. Participants were randomly assigned into each group. In the first and twelfth week of the intervention, all patients were assessed with the Pediatric Quality of Life Inventory (PedsQLTM) questionnaire cancer module 3.0 (report by proxy or self-report). Symptoms intensity (pain, anorexia, sleep disturbance) were scored by using Edmonton Symptoms Assessment Scale (ESAS). Mean score and each dimension score of both group were compared and analyzed using bivariate analysis. Results: A total 50 participants were included in analysis. Significant difference was found between two groups with average total score in control group 62.39 and intervention group 81.63 (p<0.001). In the intervention group QoL tends to improve, whereas in the control group, those did not get palliative intervention, quality of life tends to decrease as the disease progress. The most improved aspect in QoL is pain and nausea (p<0.001), followed by procedural anxiety (p=0.002), treatment anxiety (p=0.002), and worry (p=0.014). Palliative intervention was found to be able to reduce sleep disturbances (p=0.003) and anorexia (p<0.001) significantly. Conclusion: Home-based PC improved several aspects of the QOL and provide better symptoms management of children with malignancies. An early intervention concurrent with the underlying treatment is believed to be able to improve their quality of life. Trial Registration: This study has been retrospectively registered in ClinicalTrials.gov ID: NCT04067687 (August, 22nd 2019).

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

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.

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Peer-led exercise program for ageing adults to improve physical functions - a randomized trial

European Review of Aging and Physical Activity ◽

10.1186/s11556-021-00257-x ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

D. R. Bouchard ◽

J. V. Olthuis ◽

V. Bouffard-Levasseur ◽

C. Shannon ◽

T. McDonald ◽

...

Keyword(s):

Physical Function ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Control Group ◽

Walk Test ◽

Blood Draw ◽

Chair Stand ◽

Significant Difference ◽

Physical Functions

Abstract Background A peer-led exercise program is one way to empower people sharing similar characteristics to encourage others to be active, but there is a lack of evidence that these programs have physical function and other benefits when delivered to ageing adults. Methods This randomized controlled trial lasting 12 weeks proposed an exercise peer-led program offered to 31 adults aged 50 and above, twice a week, by a trained leader of the same age from March to May 2019. The program was offered for free with limited space and equipment. Valid tests of physical function (e.g., 30-s chair stand, 6-min walk test) were used to assess the functional benefits. Psychosocial outcomes were assessed using self-reported questionnaires and metabolic outcomes via a fasted blood draw. Results A significant difference was found between pre-and post-values in most physical function tests in the intervention group (all p < 0.05). When adjusted for potential confounders, the intervention group was significantly associated with a more significant improvement on the chair stand test (ß = .26; p < 0.001; r2 = 0.26), the arm curl (ß = .29; p < 0.001; r2 = 0.49), as well as the 6-min walk test (ß = -.14; p < 0.001; r2 = 0.62) compared with the control group. Using repetitive measures generalized linear model, the interaction between the changes and the group was significant for all three tests. Benefits were also observed for participants’ stress level and perceived health in the intervention group compared to the control. Finally, no significant difference was observed between groups for metabolic health. Conclusions The current work suggests that a 12-week peer-led exercise program can improve physical function for adults age 50 and above. Trial registration NCT03799952(ClinicalTrials.gov) 12/20/2018.

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Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Keivan Ranjbar ◽

Mohsen Moghadami ◽

Alireza Mirahmadizadeh ◽

Mohammad Javad Fallahi ◽

Vahid Khaloo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Clinical Status ◽

Intervention Group ◽

Length Of Hospital Stay ◽

Ordinal Scale ◽

Control Group ◽

Randomized Controlled ◽

Group Data ◽

Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

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Effect of Engaging Trainees by Assessing Peer Performance: A Randomised Controlled Trial Using Simulated Patient Scenarios

BioMed Research International ◽

10.1155/2014/610591 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7 ◽

Cited By ~ 5

Author(s):

Charlotte Loumann Krogh ◽

Charlotte Ringsted ◽

Charles B. Kromann ◽

Maria Birkvad Rasmussen ◽

Tobias Todsen ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Global Rating ◽

Training Performance ◽

Significant Difference ◽

Training Format ◽

Peer Performance ◽

And Performance ◽

Randomised Controlled

Introduction. The aim of this study was to explore the learning effect of engaging trainees by assessing peer performance during simulation-based training.Methods. Eighty-four final year medical students participated in the study. The intervention involved trainees assessing peer performance during training. Outcome measures were in-training performance and performance, both of which were measured two weeks after the course. Trainees’ performances were videotaped and assessed by two expert raters using a checklist that included a global rating. Trainees’ satisfaction with the training was also evaluated.Results. The intervention group obtained a significantly higher overall in-training performance score than the control group: mean checklist score 20.87 (SD 2.51) versus 19.14 (SD 2.65)P=0.003and mean global rating 3.25 SD (0.99) versus 2.95 (SD 1.09)P=0.014. Postcourse performance did not show any significant difference between the two groups. Trainees who assessed peer performance were more satisfied with the training than those who did not: mean 6.36 (SD 1.00) versus 5.74 (SD 1.33)P=0.025.Conclusion. Engaging trainees in the assessment of peer performance had an immediate effect on in-training performance, but not on the learning outcome measured two weeks later. Trainees had a positive attitude towards the training format.

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Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19020735 ◽

2022 ◽

Vol 19 (2) ◽

pp. 735

Author(s):

Yong-Soon Yoon ◽

Myoung-Hwan Ko ◽

Il-Young Cho ◽

Cheol-Su Kim ◽

Johny Bajgai ◽

...

Keyword(s):

Physical Therapy ◽

Short Form ◽

Therapy Group ◽

Controlled Trial ◽

Low Frequency ◽

Control Group ◽

Mcgill Pain Questionnaire ◽

Low Frequency Stimulation ◽

Significant Difference ◽

Frequency Stimulation

Electrotherapy is commonly used for myalgia alleviation. Low-frequency stimulation (LFS) is primarily used for controlling acute and chronic pain and is a non-invasive therapy that can be easily performed with electric stimulation applied on the skin. However, little evidence exists regarding the pain alleviation effects of personal low-frequency stimulation device for home use. Moreover, no studies have compared myalgia alleviation effects between personal low-frequency stimulation (PLS) and physical therapy (PT), which are most commonly used for patients with myalgia in hospitals and clinics. Therefore, we aimed to investigate the pain alleviation effects of PLS in patients with myalgia and compare these effects with those of conventional PT (transcutaneous electrical nerve stimulation + ultrasound). In total, 39 patients with myalgia in the neck, shoulder, back, and waist areas were randomly assigned to the personal low-frequency stimulation group (PLSG: n = 20) and physical therapy group (PTG: n = 19). Both groups were treated for 3 weeks (20 min per session and 5 sessions per week). Patients were assessed for pain intensity by surface electromyography (sEMG), visual analogue scale (VAS) and a short-form McGill pain questionnaire (SF-MPQ) before and after the intervention period. Our results showed that PLSG showed a tendency of muscle relaxation with a significant decrease in sEMG in the neck (p = 0.0425), shoulder (p = 0.0425), and back (p = 0.0046) areas compared to the control group. However, there was no significant difference in waist area. Additionally, VAS scores significantly decreased between pre- and post-treatment in both PTG (p = 0.0098), and PLSG (p = 0.0304) groups, but there was no significance difference between the groups. With respect to SF-MPQ, the PLSG showed greater pain alleviation (5.23 ± 0.25) effects than the PTG (6.23 ± 0.25). Accordingly, our results suggest that PLS treatment using a home device might offer positive assistance in pain alleviation for patients with myalgia that is as equally effective as conventional PT treatment. However, further detailed studies are required considering larger samples to fully claim the effectiveness of this device.

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The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

Iranian Journal of Psychiatry and Behavioral Sciences ◽

10.5812/ijpbs.98256 ◽

2020 ◽

Vol 14 (2) ◽

Author(s):

Maryam Montazeri ◽

Khalil Esmaeilpour ◽

Sakineh Mohammad-Alizadeh-Charandabi ◽

Sevda Golizadeh ◽

Mojgan Mirghafourvand

Keyword(s):

Randomized Controlled Trial ◽

Pregnant Women ◽

Controlled Trial ◽

Block Design ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Writing Therapy ◽

Randomized Block Design ◽

Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

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Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial

Psychological Medicine ◽

10.1017/s0033291713002249 ◽

2013 ◽

Vol 44 (7) ◽

pp. 1521-1532 ◽

Cited By ~ 54

Author(s):

A. van Straten ◽

J. Emmelkamp ◽

J. de Wit ◽

J. Lancee ◽

G. Andersson ◽

...

Keyword(s):

Controlled Trial ◽

Sleep Onset ◽

Intervention Group ◽

Sleep Diary ◽

The Internet ◽

Control Group ◽

Sleep Onset Latency ◽

Cognitive Behavioural ◽

Co Morbidity ◽

Significant Difference

BackgroundInsomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT delivered through the Internet might be a more accessible alternative. In this study we examined the effectiveness of a guided Internet-delivered CBT for adults with insomnia using a randomized controlled trial (RCT).MethodA total of 118 patients, recruited from the general population, were randomized to the 6-week guided Internet intervention (n = 59) or to a wait-list control group (n = 59). Patients filled out an online questionnaire and a 7-day sleep diary before (T0) and after (T1) the 6-week period. The intervention group received a follow-up questionnaire 3 months after baseline (T2).ResultsAlmost three-quarters (72.9%) of the patients completed the whole intervention. Intention-to-treat (ITT) analysis showed that the treatment had statistically significant medium to large effects (p < 0.05; Cohen's d between 0.40 and 1.06), and resulted more often in clinically relevant changes, on all sleep and secondary outcomes with the exception of sleep onset latency (SOL) and number of awakenings (NA). There was a non-significant difference in the reduction in sleep medication between the intervention (a decrease of 6.8%) and control (an increase of 1.8%) groups (p = 0.20). Data on longer-term effects were inconclusive.ConclusionsThis study adds to the growing body of literature that indicates that guided CBT for insomnia can be delivered through the Internet. Patients accept the format and their sleep improves.

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