Mindful Walking in Psychologically Distressed Individuals: A Randomized Controlled Trial

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress.Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen’s Perceived Stress Scale (CPSS) after 4 weeks between intervention and control.Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were −8.8 [95% CI: −10.8; −6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and −1.0 [−2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference ().Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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Effect of hydration with oral water on nonstress test in a hospital, Turkey: a randomized controlled trial

Journal of Health Research ◽

10.1108/jhr-12-2020-0647 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Yeter Şener ◽

Hüseyin Aksoy ◽

Mürüvvet Başer

Keyword(s):

Pregnant Women ◽

Controlled Trial ◽

Stress Test ◽

Intervention Group ◽

Median Number ◽

Control Group ◽

Normal Range ◽

Content Type ◽

Randomized Controlled ◽

Study Intervention

PurposeThe aim of this study was to assess the effect of hydration with oral water on non-stress test (NST).Design/methodology/approachThe study was conducted as single-blinded and randomized controlled. Healthy and outpatient 32- to 40-week pregnant women who were aged 19 and older were included in the study. Intervention group pregnant women (n = 66) drank 500 ccs of water before the NST, and no attempt was made to the control group (n = 66). The NST parameters of the groups with fetal heart rate (FHR), variability, acceleration, deceleration, reactivity and nonreactivity were evaluated.FindingsBoth groups were found to be similar in terms of their descriptive characteristics and variables related to pregnancy (p > 0.05). The median FHR was 130.0 in the intervention group, 140.0 in the control group (p < 0.001), and the median number of the acceleration was 6.0 in the intervention group and 4.0 in the control group (p < 0.001). In terms of the median number of decelerations, the groups were similar (p > 0.05).Originality/valueIt was found that hydration with oral water had an effect on NST parameters of FHR and the number of accelerations. However, it was observed that the FHR was within the normal range in both groups. It was thought that it tended to increase the number of accelerations.

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Efficacy of an Objective Structured Clinical Examination Training Approach for Training Pharmacy Students in Diabetes Mellitus Counseling: A Randomized Controlled Trial

Pharmacy ◽

10.3390/pharmacy8040229 ◽

2020 ◽

Vol 8 (4) ◽

pp. 229

Author(s):

Imaneh Farahani ◽

Samieh Farahani ◽

Maira A. Deters ◽

Holger Schwender ◽

Stephanie Laeer

Keyword(s):

Diabetes Mellitus ◽

Communication Skills ◽

Controlled Trial ◽

Objective Assessment ◽

Intervention Group ◽

Pharmacy Students ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Training Approach

Pharmacists’ tasks are multifaceted and include, for example, vital counseling and communication skills. Objective Structured Clinical Examinations (OSCEs) could be used to train pharmacy students in these skills. Our study sought to determine the efficacy of our OSCE training approach for training pharmacy students’ counseling and communication skills on diabetes mellitus compared to a control group. This randomized controlled study was conducted with pharmacy students using a pre-post-design. The intervention group completed diabetes OSCE training, while the control group solved diabetes patient cases using subjective, objective, assessment, and plan notes. Before and after the respective training, both groups completed OSCEs evaluating counseling and communication skills. Before each OSCE encounter, the participants completed a self-assessment questionnaire and, upon completion of the seminar, filled out a satisfaction survey. The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group. Both groups were generally satisfied with the seminar. These results demonstrate that our OSCE training approach allows for the effective training of pharmacy students’ diabetes counseling and communication skills and suggests the inclusion of such a skill-based approach more widely in pharmacy students’ education.

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Meridian Cuffing Exercises Improved Functional Fitness and Cardiopulmonary Functioning of Community Older Adults

Clinical Nursing Research ◽

10.1177/1054773818768021 ◽

2018 ◽

Vol 29 (1) ◽

pp. 37-47 ◽

Cited By ~ 1

Author(s):

Hsiao-Ting Tung ◽

Chi-Chieh Lai ◽

Kuei-Min Chen ◽

Han-Ya Tsai

Keyword(s):

Older Adults ◽

Community Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Fitness ◽

Randomized Controlled ◽

Cluster Randomized ◽

Study Intervention ◽

Single Blind

This study was aimed to test the effects of a meridian cuffing exercise, the Healthy Beat Acupunch (HBA) regimen, on the functional fitness and cardiopulmonary functioning of community older adults. A single-blind, cluster randomized controlled trial was conducted. We randomly allocated eight community care centers to the intervention or control group and recruited 228 participants who completed the study (intervention: four centers, n = 111; control: four centers, n = 117). The intervention group underwent a 40-min session of HBA regimen 3 times per week for 6 months. Functional fitness and cardiopulmonary functioning were assessed at baseline, 3 months, and 6 months of the intervention. The intervention group demonstrated significantly greater improvements in functional fitness and cardiopulmonary functioning than the control group between baseline and either 3 months or 6 months. We suggest that activities designed to promote health among community older adults include acupunch exercises.

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Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews (Preprint)

10.2196/preprints.19861 ◽

2020 ◽

Author(s):

Cyd Eaton ◽

Margaret Comer ◽

Cozumel Pruette ◽

Kevin Psoter ◽

Kristin Riekert

Keyword(s):

Randomized Controlled Trial ◽

Young Adults ◽

Medication Adherence ◽

Active Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Significant Group ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

BACKGROUND Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. OBJECTIVE In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. METHODS In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. RESULTS Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, <i>P</i>=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). CONCLUSIONS The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. CLINICALTRIAL ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

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Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews

Journal of Medical Internet Research ◽

10.2196/19861 ◽

2020 ◽

Vol 22 (8) ◽

pp. e19861

Author(s):

Cyd Eaton ◽

Margaret Comer ◽

Cozumel Pruette ◽

Kevin Psoter ◽

Kristin Riekert

Keyword(s):

Randomized Controlled Trial ◽

Young Adults ◽

Medication Adherence ◽

Active Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Significant Group ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Background Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

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Evaluation of the Efficacy of Psychological Interventions in Promoting Preparedness to Armed Conflicts – A Randomized Controlled Study

Disaster Medicine and Public Health Preparedness ◽

10.1017/dmp.2018.119 ◽

2018 ◽

Vol 13 (4) ◽

pp. 713-723

Author(s):

Moran Bodas ◽

Maya Siman-Tov ◽

Shulamith Kreitler ◽

Kobi Peleg

Keyword(s):

Psychological Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Civil Defense ◽

Armed Conflicts ◽

Controlled Study ◽

Control Group ◽

Psychological Interventions ◽

Randomized Controlled ◽

External Reward

ABSTRACTObjectiveDespite efforts by civil defense authorities, levels of households’ preparedness to emergencies remain insufficient in many countries. Engaging the public in preparedness behavior is a challenge worldwide. The purpose of this study was to explore the efficacy of psychological intervention in promoting preparedness behavior to armed conflicts in Israel.MethodsA randomized controlled trial (N = 381) with two control groups and three intervention groups was used. The psychological interventions studied were elevated threat perception, external reward, and manipulation of a cognitive cluster related to preparedness.ResultsThe results of the analysis suggest a significant effect of intervention on the increase of reported preparedness (F4,375 = 4.511, P = 0.001). The effect is attributed to the intervention group in which external reward was offered. Participants in this group were about two times more likely to report greater levels of preparedness compared to the control group (RR = 1.855; 95% CI: 1.065, 3.233).ConclusionsThe findings suggest that preparedness behavior can be promoted through external incentives. These are presumably effective motivators because they encourage preparedness while allowing subjects to retain their denial as an adaptive coping mechanism. Innovative thinking is required to overcome the psychological barriers associated with public reluctance to engage in preparedness. (Disaster Med Public Health Preparedness. 2018;13:713–723)

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Effects of Long-Term Use of Insoles with a Toe-Grip Bar on the Balance, Walking, and Running of Preschool Children: A Randomized Controlled Trial

BioMed Research International ◽

10.1155/2020/1940954 ◽

2020 ◽

Vol 2020 ◽

pp. 1-6

Author(s):

Hideki Nakano ◽

Shin Murata ◽

Teppei Abiko ◽

Nozomi Mitsumaru ◽

Atsuko Kubo ◽

...

Keyword(s):

Preschool Children ◽

Controlled Trial ◽

Intervention Group ◽

Step Length ◽

Controlled Study ◽

Control Group ◽

Randomized Controlled ◽

Before And After ◽

Length Step

This randomized controlled study is aimed at investigating the effects of long-term use of insoles with a toe-grip bar on the balance, walking, and running of preschool children. Fifty-two preschool children were randomly assigned to an intervention group or control group. Children included in the intervention group wore shoes with insoles that had a toe-grip bar, and those in the control group wore shoes with regular insoles without a toe-grip bar for 4 weeks while they were at school. The center of gravity sway (total trajectory length and envelope area), walking parameters (walking speed, cadence, stride length, step length, stance time, and swing time), and time to run 25 m were measured before and after the intervention. The 25 m running time of the intervention group was significantly improved after the intervention (F=5.66; p<0.05). This study suggests that insoles with a toe-grip bar may contribute to improvements in the running of preschool children.

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Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial

Psychological Medicine ◽

10.1017/s0033291720003955 ◽

2020 ◽

pp. 1-9

Author(s):

JianLi Wang ◽

Heidi Eccles ◽

Molly Nannarone ◽

Norbert Schmitz ◽

Scott Patten ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Psychological Distress ◽

Mixed Methods ◽

Functional Impairment ◽

Controlled Trial ◽

Intervention Group ◽

Risk Information ◽

Control Group ◽

Randomized Controlled ◽

Depression Risk

Abstract Background Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months. Methods A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months. Results Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12–2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health. Conclusions This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning. Trial registration ClinicalTrials.gov NCT02943876

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Universal Screening and Decolonization for Control of MRSA in Nursing Homes: A Cluster Randomized Controlled Study

Infection Control and Hospital Epidemiology ◽

10.1017/ice.2014.74 ◽

2015 ◽

Vol 36 (4) ◽

pp. 401-408 ◽

Cited By ~ 13

Author(s):

Cristina Bellini ◽

Christiane Petignat ◽

Eric Masserey ◽

Christophe Büla ◽

Bernard Burnand ◽

...

Keyword(s):

Universal Screening ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Standard Precautions ◽

Carriage Rate ◽

Randomized Controlled ◽

Cluster Randomized ◽

The Impact

OBJECTIVEThe risk of carrying methicillin-resistant Staphylococcus aureus (MRSA) is higher among nursing home (NH) residents than in the general population. However, control strategies are not clearly defined in this setting. In this study, we compared the impact of standard precautions either alone (control) or combined with screening of residents and decolonization of carriers (intervention) to control MRSA in NHs.DESIGNCluster randomized controlled trialSETTINGNHs of the state of Vaud, SwitzerlandPARTICIPANTSOf 157 total NHs in Vaud, 104 (67%) participated in the study.INTERVENTIONStandard precautions were enforced in all participating NHs, and residents underwent MRSA screening at baseline and 12 months thereafter. All carriers identified in intervention NHs, either at study entry or among newly admitted residents, underwent topical decolonization combined with environmental disinfection, except in cases of MRSA infection, MRSA bacteriuria, or deep skin ulcers.RESULTSNHs were randomly allocated to a control group (51 NHs, 2,412 residents) or an intervention group (53 NHs, 2,338 residents). Characteristics of NHs and residents were similar in both groups. The mean screening rates were 86% (range, 27%–100%) in control NHs and 87% (20%–100%) in intervention NHs. Prevalence of MRSA carriage averaged 8.9% in both control NHs (range, 0%–43%) and intervention NHs (range, 0%–38%) at baseline, and this rate significantly declined to 6.6% in control NHs and to 5.8% in intervention NHs after 12 months. However, the decline did not differ between groups (P=.66).CONCLUSIONUniversal screening followed by decolonization of carriers did not significantly reduce the prevalence of the MRSA carriage rate at 1 year compared with standard precautions.Infect Control Hosp Epidemiol 2015;00(0): 1–8

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