scholarly journals Qigong mind-body program for caregivers of cancer patients: design of a pilot three-arm randomized clinical trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Pinky Shani ◽  
Kristin Raeesi ◽  
Eli Walter ◽  
Kai Lewis ◽  
Wanyi Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Community Based Interventions ◽  
Community Based ◽  
Online Delivery ◽  
Link Type ◽  
Cancer Caregivers

Abstract Background Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers’ economic, geographic, and time constraints. Translation of in-person, community-based interventions to Internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence. Methods Caring for Caregivers with Mind-Body implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong, (2) Internet-based Qigong, or (3) a self-care control group. Study-specific aims include (1) modify intervention content for online delivery, (2) evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial, and (3) evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial well-being. Discussion Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs Internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers. Trial registration NCT04019301; registered on July 15, 2019; clinicaltrials.gov

scholarly journals Qigong Mind-Body Program for Caregivers of Cancer Patients: Design of a Pilot Three-Arm Randomized Clinical Trial

2020 ◽  
Author(s):  
Pinky Budhrani-Shani ◽  
Kristin Raeesi ◽  
Eli Walter ◽  
Kai Lewis ◽  
Wanyi Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Community Based Interventions ◽  
Community Based ◽  
Online Delivery ◽  
Psychosocial Wellbeing ◽  
Intervention Content ◽  
Cancer Caregivers

Abstract Background: Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers’ economic, geographic, and time constraints. Translation of in-person, community-based interventions to internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence.Methods: Caring for Caregivers with Mind-Body Exercise implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong; (2) internet-based Qigong; or (3) a self-care control group. Study specific aims include 1) Modify intervention content for online delivery; 2) Evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial; and 3) Evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial wellbeing.Discussion: Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers.Trial registration: NCT04019301; registered on July 15, 2019; clinicaltrials.gov.

scholarly journals Qigong mind-body program for caregivers of cancer patients: Design of a pilot three-arm randomized clinical trial

2020 ◽  
Author(s):  
Pinky Shani ◽  
Kristin Raeesi ◽  
Eli Walter ◽  
Kai Lewis ◽  
Wanyi Wang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Control Group ◽  
Community Based Interventions ◽  
Community Based ◽  
Online Delivery ◽  
Psychosocial Wellbeing ◽  
Intervention Content ◽  
Cancer Caregivers

Abstract Background: Informal caregivers, often family and friends, experience significant psychological and physical distress leading to reductions in health and quality of life (QOL). Mind-body interventions focused on caregivers are often limited and do not address multiple barriers, including caregivers’ economic, geographic, and time constraints. Translation of in-person, community-based interventions to internet-based delivery may offer greater accessibility for caregivers, leading to increased adherence. Methods: Caring for Caregivers with Mind-Body Exercise implements a three-arm, pilot, randomized controlled trial to evaluate the feasibility of delivering a Qigong intervention (Eight Brocades) to cancer caregivers. A total of 54 cancer caregivers will be randomized into one of three 12-week programs: (1) community-based Qigong; (2) internet-based Qigong; or (3) a self-care control group. Study specific aims include 1) Modify intervention content for online delivery; 2) Evaluate the feasibility of recruiting and retaining cancer caregivers into a 12-week clinical trial; and 3) Evaluate the feasibility of collecting and managing data, and the suitability of questionnaires for this population. Several outcomes will be assessed, including caregiver QOL, caregiver burden, caregiver distress, perceived social support, physical function, and cognitive function. A 6-month follow-up will also assess longer-term changes in QOL and psychosocial wellbeing.Discussion: Findings will be used to inform the design and conduct of a large-scale comparative effectiveness trial evaluating caregivers who received Qigong training delivered through community-based vs internet-based programs. A finding that either or both programs are effective would inform care and options for caregivers.Trial registration: NCT04019301; registered on July 15, 2019; clinicaltrials.gov.

scholarly journals Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640)

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e031290
Author(s):  
Erica Schytt ◽  
Anna Wahlberg ◽  
Amani Eltayb ◽  
Rhonda Small ◽  
Nataliia Tsekhmestruk ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Well Being ◽  
Ethical Review ◽  
Control Group ◽  
Migrant Women ◽  
Intrapartum Care ◽  
Community Based ◽  
Randomised Controlled

IntroductionMigrant women consistently rate their care during labour and birth more negatively than non-migrant women, due to communication difficulties, lack of familiarity with how care is provided, and discrimination and prejudicial staff attitudes. They also report being left alone, feeling fearful, unsafe and unsupported, and have poorer birth outcomes than non-migrant women. Community-based doulas (CBDs) are bilingual women from migrant communities who are trained in childbirth and labour support, and who facilitate communication between woman-partner-staff during childbirth. This study protocol describes the design, rationale and methods of a randomised controlled trial that aims to evaluate the effectiveness of CBD support for improving the intrapartum care experiences and postnatal well-being of migrant women giving birth in Sweden.Methods and analysisA randomised controlled trial. From six antenatal care clinics in Stockholm, Sweden, we aim to recruit 200 pregnant Somali, Arabic, Polish, Russian and Tigrinya-speaking women who cannot communicate fluently in Swedish, are 18 years or older and with no contraindications for vaginal birth. In addition to standard labour support, women are randomised to CBD support (n=100) or no such support during labour (n=100). Trained CBDs meet with women once or twice before the birth, provide emotional, physical and communication support to women throughout labour and birth in hospital, and then meet with women once or twice after the birth. Women’s ratings of the intrapartum care experiences and postnatal well-being are assessed at 6–8 weeks after the birth using selected questions from the Migrant Friendly Maternity Care Questionnaire and by the Edinburgh Postnatal Depression Scale. The intervention group will be compared with the control group using intention-to-treat analyses. ORs and 95% CIs will be estimated and adjustments made if key participant characteristics differ between trial arms.Ethics and disseminationThe study was approved by the Regional Ethical Review Board in Stockholm (approval number: 2018/12 - 31/2).Trial registration numberNCT03461640; Pre-results.

scholarly journals Changing personality traits with the help of a digital personality change intervention

2021 ◽  
Vol 118 (8) ◽  
pp. e2017548118 ◽  
Author(s):  
Mirjam Stieger ◽  
Christoph Flückiger ◽  
Dominik Rüegger ◽  
Tobias Kowatsch ◽  
Brent W. Roberts ◽  
...  
Keyword(s):  
Personality Traits ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
Smartphone Application ◽  
Personality Change ◽  
Control Group ◽  
Life Outcomes ◽  
Normal Personality ◽  
Waitlist Control Group

Personality traits predict important life outcomes, such as success in love and work life, well-being, health, and longevity. Given these positive relations to important outcomes, economists, policy makers, and scientists have proposed intervening to change personality traits to promote positive life outcomes. However, nonclinical interventions to change personality traits are lacking so far in large-scale naturalistic populations. This study (n = 1,523) examined the effects of a 3-mo digital personality change intervention using a randomized controlled trial and the smartphone application PEACH (PErsonality coACH). Participants who received the intervention showed greater self-reported changes compared to participants in the waitlist control group who had to wait 1 mo before receiving the intervention. Self-reported changes aligned with intended goals for change and were significant for those desiring to increase on a trait (d = 0.52) and for those desiring to decrease on a trait (d = −0.58). Observers such as friends, family members, or intimate partners also detected significant personality changes in the desired direction for those desiring to increase on a trait (d = 0.35). Observer-reported changes for those desiring to decrease on a trait were not significant (d = −0.22). Moreover, self- and observer-reported changes persisted until 3 mo after the end of the intervention. This work provides the strongest evidence to date that normal personality traits can be changed through intervention in nonclinical samples.

scholarly journals Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Brenna Lin ◽  
Christopher Prickett ◽  
Steven Woltering
Keyword(s):  
College Students ◽  
Mindfulness Meditation ◽  
Controlled Trial ◽  
Scientific Evidence ◽  
Well Being ◽  
Open Science ◽  
Control Group ◽  
Test Procedures ◽  
The Usa ◽  
Biofeedback Device

Abstract Background Stress can negatively impact an individual’s health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device. Method Data were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated. Results Participant device-adherence as well as the company’s collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device. Conclusions Our findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness. Trial registration NCT02837016. Registered 19 July 2016.

scholarly journals Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Marouf Alhalabi ◽  
Mohammed Waleed Alassi ◽  
Kamal Alaa Eddin ◽  
Khaled Cheha
Keyword(s):  
Clinical Trial ◽  
Helicobacter Pylori ◽  
Confidence Interval ◽  
Odds Ratio ◽  
Controlled Trial ◽  
Helicobacter Pylori Infection ◽  
First Line ◽  
Link Type ◽  
Syrian Population

Abstract Background Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population. Settings and design An open-label, randomised, parallel, superiority clinical trial. Methods We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment. Results Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454–4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394–3.774]. We didn’t report serious adverse effects. Conclusions Levofloxacin concomitant therapy wasn’t superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population. Trial registration We registered this study as a standard randomized clinical trial (Clinicaltrial.gov, identifier-NCT04348786, date:29-January-2020).

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

scholarly journals Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BMC Nursing ◽  
2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Olga L. Cortés ◽  
Mauricio Herrera-Galindo ◽  
Juan Carlos Villar ◽  
Yudi A. Rojas ◽  
María del Pilar Paipa ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Critical Care ◽  
Pressure Ulcers ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Despite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals. Methods A nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study. Conclusion This study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk. Trial registration PENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

scholarly journals The utility of self-rated health in population surveys: the role of bodyweight

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Robert Bozick
Keyword(s):  
Treatment Group ◽  
Large Scale ◽  
Well Being ◽  
Control Group ◽  
Self Rated Health ◽  
Risk Of Mortality ◽  
Highly Sensitive ◽  
The Usa ◽  
Group Members ◽  
Nationally Representative

Abstract Background Self-rated health (SRH) is one of the most commonly used summary measures of overall health and well-being available to population scientists due to its ease of administration in large-scale surveys and to its efficacy in predicting mortality. This paper assesses the extent to which SRH is affected by its placement before or after questions about bodyweight on a survey, and whether differences in placement on the questionnaire affects SRH’s predictive validity. Methods I assessed the validity of SRH in predicting the risk of mortality by comparing outcomes of sample members who were asked to rate their health before reporting on their bodyweight (the control group) and sample members who were asked to rate their health after reporting on their bodyweight (the treatment group). Both the control and treatment group were randomly assigned via an experiment administered as a module in a nationally representative sample of adults in the USA in 2019 (N = 2523). Results The odds of reporting a more favorable appraisal of health are 30% lower for sample members who were in the treatment group when compared with the control group. Additionally, the SRH of treatment group members is significantly associated with their risk of mortality, while the SRH of control group members is not. Conclusion The findings from this study suggest that for researchers to maximize the utility of SRH, closer attention needs to be paid to the context of the survey within which it asked. SRH is highly sensitive to the questions that precede it, and this sensitivity may in turn mischaracterize the true health of the population that the survey is intending to measure.

scholarly journals Community-based interventions for childhood asthma using comprehensive approaches: a systematic review and meta-analysis

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Mei Chan ◽  
Melinda Gray ◽  
Christine Burns ◽  
Louisa Owens ◽  
Susan Woolfenden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Childhood Asthma ◽  
Action Plan ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Mean Difference ◽  
Cochrane Library ◽  
Care Utilization ◽  
Community Based Interventions ◽  
Community Based

Abstract Objective We conducted a systematic review and meta-analysis to determine the effectiveness of comprehensive community-based interventions with ≥ 2 components in improving asthma outcomes in children. Methods A systematic search of Medline, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica Database (EMBASE), Cochrane Library and hand search of reference collections were conducted to identify any research articles published in English between 2000 and 2019. All studies reporting community-based asthma interventions with ≥ 2 components (e.g., asthma self-management education, home environmental assessment or care coordination etc.) for children aged ≤ 18 years were included. Meta-analyses were performed using random-effects model to estimate pooled odds ratio (OR) with 95% confidence intervals (CIs). Results Of the 2352 studies identified, 21 studies were included in the final analysis: 19 pre-post interventions, one randomised controlled trial (RCT) and one retrospective study. Comprehensive asthma programs with multicomponent interventions were associated with significant reduction in asthma-related Emergency Department (ED) visits (OR = 0.26; 95% CI 0.20–0.35), hospitalizations (OR = 0.24; 95% CI 0.15–0.38), number of days (mean difference = − 2.58; 95% CI − 3.00 to − 2.17) and nights with asthma symptoms (mean difference = − 2.14; 95% CI − 2.94 to − 1.34), use of short-acting asthma medications/bronchodilators (BD) (OR = 0.28; 95% CI 0.16–0.51), and increase use of asthma action plan (AAP) (OR = 8.87; 95% CI 3.85–20.45). Conclusion Community-based asthma care using more comprehensive approaches may improve childhood asthma management and reduce asthma related health care utilization.

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