scholarly journals Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial

10.2196/14542 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14542 ◽  
Author(s):  
Erandi Hewawasam ◽  
Leah Brennan ◽  
Lynne Giles ◽  
Mary Louise Hull ◽  
Asha Short ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Psychological Distress ◽  
Adolescent Girls ◽  
Management Strategy ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Well Being ◽  
Self Management ◽  
Control Group

Background Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods, hirsutism, acne, or hyperandrogenemia. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents. Objective This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS. Methods This study is a randomized controlled trial that will be conducted over eight weeks at the Women’s and Children’s Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels. Results The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure. Conclusions This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&isReview=true

scholarly journals Assessing Whether Meditation Improves Quality of Life for Adolescent Girls With Polycystic Ovary Syndrome: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Erandi Hewawasam ◽  
Leah Brennan ◽  
Lynne Giles ◽  
Mary Louise Hull ◽  
Asha Short ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Psychological Distress ◽  
Adolescent Girls ◽  
Management Strategy ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Well Being ◽  
Self Management ◽  
Control Group

BACKGROUND Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterized by irregular periods and hyperandrogenism. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation (TM) is a well-established self-management strategy that has been used to improve stress and well-being. A meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. Recent data are suggesting that another self-management strategy called a mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents. OBJECTIVE This study aims to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS. METHODS This study is a randomized controlled trial that will be conducted over eight weeks at the Women’s and Children’s Hospital in Adelaide, South Australia, to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. A total of 40 girls will be randomized into either the TM (n=20) or control group (n=20). The TM group will be asked to practice TM in a comfortable sitting position with the eyes closed, for 15 minutes twice daily over eight weeks. The control group will be asked to sit quietly for 15 minutes twice daily for eight weeks. The primary outcomes are any effects on improving QOL and psychological distress, and the secondary outcomes are any effects on lowering blood pressure and salivary cortisol levels. RESULTS The recruitment of study participants began in May 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over eight weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also, it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure. CONCLUSIONS This study will be the first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide valuable information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS. CLINICALTRIAL Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN1261900019010; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376657&isReview=true INTERNATIONAL REGISTERED REPORT PRR1-10.2196/14542

Effect of Patient-Centered Self-Management Program on Blood Pressure, Renal Function Control, and the Quality of Life of Patients With Hypertensive Nephropathy: A Longitudinal Randomized Controlled Trial

2021 ◽  
pp. 109980042110618
Author(s):  
Mei-Chen Lee ◽  
Shu-Fang Vivienne Wu ◽  
Kuo-Cheng Lu ◽  
Wen-Hug Wang ◽  
Yen-Yen Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Blood Pressure ◽  
Controlled Trial ◽  
Management Program ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Hypertensive Nephropathy ◽  
Experimental Group

This longitudinal study with a randomized controlled trial evaluated the long-term effectiveness of the patient-centered self-management intervention program on the control of blood pressure and renal function, as well as the quality of life of patients with hypertensive nephropathy. The control group ( n = 38) received usual care while the experimental group ( n = 38) participated in a patient-centered self-management program. After the pre-test, the intervention was performed with the experimental group once a week for a total of 4 weeks. Then, the post-test was performed 1, 3, and 6 months later. A questionnaire was used to collect the demographic data and disease characteristics, laboratory data, and quality of life scale. This study tracked three time points (i.e., 1, 3, and 6 months) after the intervention and found that the experimental group achieved significant results in controlling systolic blood pressure ( p < 0.001), diastolic blood pressure ( p = 0.007), and eGFR ( p = 0.013). Significant results were achieved in the overall quality of life ( p < 0.001) and the quality of life in the physical (PHC; p < 0.001) and mental health components (MHC; p < 0.001). Furthermore, the effects in the experimental group lasted for as long as 6 months and were better than those in the control group. Moreover, this program can provide nursing staff with a reference different from traditional health education methods.

scholarly journals Gamification as an entrepreneur well-being intervention: A study protocol for a single-blinded randomised controlled trial

2021 ◽  
Author(s):  
Waqar M. Naqvi
Keyword(s):  
Controlled Trial ◽  
Life Quality ◽  
Well Being ◽  
Likert Scale ◽  
Control Group ◽  
Group A ◽  
Measuring Scale ◽  
Group B ◽  
Randomised Controlled

Abstract Entrepreneurs usually work for long hours resulting in exhaustion, stress, and burnout. The prevalent symptoms of burnout are reduced levels of physical and mental energy, reduced job efficiency and diminished productivity. Therefore, it is important to improve the health of entrepreneurs. Gamification has a positive relationship with improvements in health and well-being as it influences positive experiences and satisfaction. This trial aims to study how 30-minutes of virtual reality game use via Kinect Azure and Oculus platforms 3-times per week, for 4 weeks, relates to differences in entrepreneur stress, burnout, subjective life quality, and downstream firm performance. We will recruit entrepreneurs over the age of 18 for the gamification analysis. Analysis of previous power using G*Power will determine the sample size. We will divide the participants into 3 groups, wherein Group A will undergo gamification on the Kinect platform, Group B will undergo the Oculus Quest intervention, and Group C will be the control group. We will conduct the study at two sites, one at the HuMen research. The outcome measures include a five-point Likert scale for measuring entrepreneurial stress, burnout-measuring scale (BMS) for burnout, five-point Likert scale for performance and SF-12 for Quality of life. Since current strains pave ways to future accomplishment, entrepreneurs' eudemonic well-being might particularly relate to forward-looking challenge stressors and burnouts. The results will provide an insight into how gamification could help entrepreneurs to deal with work stress and maintain high well-being.

A Proposal of an innovative program for informal caregivers of patients with mood disorders

2017 ◽  
Vol 41 (S1) ◽  
pp. S603-S603
Author(s):  
J. Cabral ◽  
C. Barreto Carvalho ◽  
P. Castilho Freitas ◽  
C. Pato
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Negative Impact ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Well Being ◽  
Control Group ◽  
Compassion Focused Therapy ◽  
The Impact

IntroductionIntervention with informal caregivers (IC) of psychiatric patients is internationally recognized as relevant and a priority. However, the existing responses in this area are still insufficient, especially regarding caregivers of individuals with mood disorders (MD). Mindfulness and compassion focused therapy have proven to be an effective approach in stress reduction and in improving emotional and social well-being of caregivers of patients with other conditions. However, no studies testing these new approaches in IC of patients with MD have been carried out. The objective of this work is to present a research project that aims to develop, implement and empirically test the effectiveness of an innovative group program to help informal caregivers of individuals with mood disorders to cope with the negative impact of the disease and reduce caregiver burdens.MethodsThe design of this experimental study to test the program's efficacy is a non-randomised controlled trial (nrct) with 12 months follow-up, with a mixed assessment methodology (quantitative and qualitative analysis). A sample of 60 informal caregivers of individuals with chronic MD will be constituted (n = 30 Control group; n= 30 Experimental group).ResultsWe expect the program to promote significant changes in participants in terms of several emotional variables (eg: burden, stress, resilience, compassion and quality of life).ConclusionsFurther efforts to continue studying the impact of interventions in caregivers should be carried out, as a way to improve the quality of life of caregivers and their ability to provide informal care to MD patients.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Comparison of hypertensive outcomes after the implementation of self-management program for older adults with uncontrolled hypertension in Krabi, Thailand: a quasi-experimental study

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Saowaluck Sukpattanasrikul ◽  
Supreeda Monkong ◽  
Sirirat Leelacharas ◽  
Orapitchaya Krairit ◽  
Chukiat Viwatwongkasem
Keyword(s):  
Quality Of Life ◽  
Blood Pressure ◽  
Older Adults ◽  
Self Care ◽  
Self Management ◽  
Uncontrolled Hypertension ◽  
Control Group ◽  
Content Type ◽  
Care Behavior

PurposeThis study aims to examine the effects of a self-management program (SMP) on self-care behavior, blood pressure and quality of life among older adults with uncontrolled hypertension.Design/methodology/approachA quasi-experimental design with repeated measures was conducted in two primary care units in Krabi, Thailand. One hundred and fifty-six older adults with uncontrolled hypertension were selected based on the inclusion criteria and divided into experimental and control groups with 78 participants in each. The experimental group received the SMP, including the intervention related to the self-management process (from the 1st to 4th weeks) and a follow-up phase (from the 5th to 16th weeks). The control group received standard care. The outcomes were measured over time, including self-care behavior (baseline, 4th and 16th weeks), blood pressure (baseline, 4th, 8th, 12th and 16th weeks) and quality of life (baseline and 16th week).FindingsThe generalized estimating equations showed that the SMP, compared with the control group, statistically significantly improved self-care behavior (p < 0.001), decreased blood pressure (p < 0.001) and improved quality of life (p < 0.001) at the 16th week.Originality/valueThe SMP improved the self-care behavior, decreased blood pressure and improved the quality of life among older adults with uncontrolled hypertension. Registered nurses could administer this program for long-term benefits and help reduce the burden on primary care services.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

AwareCare: a pilot randomized controlled trial of an awareness-based staff training intervention to improve quality of life for residents with severe dementia in long-term care settings

2012 ◽  
Vol 25 (1) ◽  
pp. 128-139 ◽  
Author(s):  
Linda Clare ◽  
Rhiannon Whitaker ◽  
Robert T Woods ◽  
Catherine Quinn ◽  
Hannah Jelley ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Care Home ◽  
Intervention Group ◽  
Well Being ◽  
Care Staff ◽  
Control Group ◽  
Severe Dementia ◽  
Term Care

ABSTRACTBackground: The extent to which care home residents with severe dementia show awareness is influenced by the extent to which the environment provides opportunities for engagement and by the way in which care staff interact with them. We aimed to establish whether training care staff to observe and identify signs of awareness in residents with severe dementia resulted in improved quality of life for residents.Methods: In this pilot cluster randomized trial, care staff in four homes (n = 32) received training and supervision and carried out structured observations of residents using the AwareCare measure (n = 32) over an eight-week period, while staff in four control homes (n = 33) had no training with regard to their residents (n = 33) and no contact with the research team. The primary outcome was resident quality of life. Secondary outcomes were resident well-being, behavior and cognition, staff attitudes and well-being, and care practices in the home.Results: Following intervention, residents in the intervention group had significantly better quality of life as rated by family members than those in the control group, but care staff ratings of quality of life did not differ. There were no other significant between-group differences. Staff participating in the intervention identified benefits in terms of their understanding of residents’ needs.Conclusions: Staff were able to use the observational measure effectively and relatives of residents in the intervention homes perceived an improvement in their quality of life.

scholarly journals Randomised controlled trial of the effects of a self-management patient education program on overall quality of life and knee pain of older people with mild to moderate knee(s) osteoarthritis

2017 ◽  
Vol 4 (2) ◽  
pp. 80
Author(s):  
Alhadi M. Jahan
Keyword(s):  
Quality Of Life ◽  
Patient Education ◽  
Education Program ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Self Management ◽  
Controlled Study ◽  
Control Group ◽  
Human Beings

<p class="abstract"><strong>Background:</strong> Knee osteoarthritis (OA) is the most important chronic rheumatic disease affecting human beings. It is more common among the older population. The objective of OA treatment is to control the symptoms, such as pain, mobility problems and consequently, to improve overall quality of life. Although, self-management patient education programs, such as educational workshops and other learning activities are effective approaches in some chronic diseases, the evidence for arthritis is still inconclusive. The aim of this trial is to compare the effectiveness of an OA of the knee self-management education program with a control group, as determined by improvements in pain and quality of life<span lang="EN-IN">. </span></p><p class="abstract"><strong>Methods:</strong> In this study, we will perform a two-group, randomized (1:1 ratio), controlled study with repeated-measures to examine the differences between the two groups over time. The research sample will be selected from the patients who are referred to a physiotherapy department with a diagnosed mild to moderate knee(s) OA, aging from 45 to 65 years<span lang="EN-IN">.</span></p><p class="abstract"><strong>Conclusions:</strong> Positive findings of this trial will pave the road for new methods of cooperation between patients and healthcare providers. Also, patient education ensures that patients are well-informed about their own health and they could avoid any deterioration and disability due to bad practices. Finally, an increased understanding helps patients to make informed decisions about their healthcare avenues.</p>

scholarly journals Mindful gratitude journaling: psychological distress, quality of life and suffering in advanced cancer: a randomised controlled trial

2021 ◽  
pp. bmjspcare-2021-003068
Author(s):  
Ting Ting Tan ◽  
Maw Pin Tan ◽  
Chee Loong Lam ◽  
Ee Chin Loh ◽  
David Paul Capelle ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Randomised Controlled Trial ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
Randomised Controlled

ContextNumerous studies have shown that gratitude can reduce stress and improve quality of life.ObjectiveOur study aimed to examine the effect of mindful gratitude journaling on suffering, psychological distress and quality of life of patients with advanced cancer.MethodsWe conducted a parallel-group, blinded, randomised controlled trial at the University of Malaya Medical Centre, Malaysia. Ninety-two adult patients with advanced cancer, and an overall suffering score ≥4/10 based on the Suffering Pictogram were recruited and randomly assigned to either a mindful gratitude journaling group (N=49) or a routine journaling group (N=43).ResultsAfter 1 week, there were significant reductions in the overall suffering score from the baseline in both the intervention group (mean difference in overall suffering score=−2.0, 95% CI=−2.7 to −1.4, t=−6.125, p=0.000) and the control group (mean difference in overall suffering score=−1.6, 95% CI=−2.3 to −0.8, t=−4.106, p=0.037). There were also significant improvements in the total Hospital Anxiety and Depression Scale score (mean difference=−3.4, 95% CI=−5.3 to −1.5, t=−3.525, p=0.000) and the total Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being score (mean difference=7.3, 95% CI=1.5 to 13.1, t=2.460, p=0.014) in the intervention group after 7 days, but not in the control group.ConclusionThe results provide evidence that 7 days of mindful gratitude journaling could positively affect the state of suffering, psychological distress and quality of life of patients with advanced cancer.Trial registration numberThe trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1261800172191) and conducted in accordance with the Declaration of Helsinki.

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