The effectiveness of intervention based on the transactional model on improving coping efforts and stress moderators in hemodialysis patients in Tehran: a randomized controlled trial

Abstract Background Present study was conducted to determine the effect of training on coping efforts and stress moderators, based on transactional model of Lazarus and Folkman, in hemodialysis patients. Methods This is a randomized controlled clinical trial on 116 hemodialysis patients referred to dialysis centers in Tehran from May to August 2018. The patients were assigned to two experimental and control groups using a simple randomization method. The intervention included 6 training sessions in the form of coping efforts and moderators of transactional model. Data were collected before and 3 months after the intervention. Data were analyzed using SPSS 16. Results After 3 months training intervention, there was significant increase in the intervention group in the mean scores of coping efforts (P < 0.001), moderators and subscales of emotional regulation from 51.18 ± 20.42 to 64.87 ± 13.18 (P < 0.001), dispositional coping style from 45.56 ± 19.45 to 55.84 ± 18.03 and social support from 49.61 ± 20.14 to 55.55 ± 17.35 (P < 0.005). Conclusion The training based on transactional model was successful in the increase of social support, dispositional coping style and emotional regulation in hemodialysis patients. Therefore, Nurses and healthcare providers can use this program to help hemodialysis patients to increase their adaptation to the illness and reduce stress. Trial registration IRCT registration number: IRCT20180524039814N1; Registration date: 13-08-2018; Registration timing: retrospectively registered: Last update: 13-08-2018.

Download Full-text

The Effectiveness of Intervention Based on the Transactional Model on Improving Coping Efforts and Stress Moderators in Hemodialysis Patients in Tehran

10.21203/rs.3.rs-410327/v1 ◽

2021 ◽

Author(s):

Mohtasham Ghaffari ◽

Mohammad Ali Morowati sharifabad ◽

Mohammad Saeed Jadgal ◽

Yadollah Mehrabi ◽

somayeh alizadeh

Keyword(s):

Emotional Regulation ◽

Healthcare Providers ◽

Intervention Group ◽

Hemodialysis Patients ◽

Controlled Clinical Trial ◽

Transactional Model ◽

Dispositional Coping ◽

The Mean ◽

And Control ◽

Randomization Method

Abstract Background: Present study was conducted to determine the effect of training on coping efforts (CE) and stress moderators, based on transactional model of Lazarus and Folkman, in hemodialysis patients (HD). Methods: This is a randomized controlled clinical trial on 116 hemodialysis patients referred to dialysis centers in Tehran from May to August 2018. The patients were assigned to two experimental and control groups using a simple randomization method. The intervention included 6 training sessions in the form of CE and moderators of transactional model. Data were collected before and 3 months after the intervention. Data were analyzed using SPSS 16.Results: After 3 months training intervention, there was significant increase in the intervention group in the mean scores of CE (P<0.001), moderators and subscales of emotional regulation (ER) from 51.18 ± 20.42 to 64.87 ± 13.18 (P<0.001), dispositional coping style (DCS) from 45.56± 19.45 to 55.84± 18.03 and social support (SS) from 49.61 ±20.14 to 55.55 ± 17.35 (P<0.005).Conclusion: The training based on transactional model was successful in the increase of SS, DCS and ER in (HD). Therefore, Nurses and healthcare providers can use this program to help (HD) to increase their adaptation to the illness and reduce stress.

Download Full-text

Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial

BMC Pediatrics ◽

10.1186/s12887-021-02635-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Mandy B. Belfort ◽

Lianne J. Woodward ◽

Sara Cherkerzian ◽

Hunter Pepin ◽

Deirdre Ellard ◽

...

Keyword(s):

Human Milk ◽

Brain Size ◽

Controlled Trial ◽

Intervention Group ◽

Controlled Clinical Trial ◽

Milk Analysis ◽

Single Center ◽

Current Standard ◽

Very Preterm ◽

Randomized Controlled

Abstract Background Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. Methods We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks’ gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks’ postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks’ PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years’ corrected age. Discussion We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). Trial registration NCT03977259, registered 6 June, 2019.

Download Full-text

App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial (Preprint)

10.2196/preprints.19624 ◽

2020 ◽

Author(s):

Stephanie Erika Bonn ◽

Mari Hult ◽

Kristina Spetz ◽

Marie Löf ◽

Ellen Andersson ◽

...

Keyword(s):

Physical Activity ◽

Bariatric Surgery ◽

Controlled Trial ◽

Intervention Group ◽

Study Participant ◽

Lifestyle Factors ◽

Lifestyle Changes ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled

BACKGROUND To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. CLINICALTRIAL ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19624

Download Full-text

A 12-Week Electronic Mentoring Employment Preparation Intervention for Youth With Physical Disabilities: Pilot Feasibility Randomized Controlled Trial (Preprint)

10.2196/preprints.12088 ◽

2018 ◽

Cited By ~ 1

Author(s):

Sally Lindsay ◽

Elaine Cagliostro ◽

Joanne Leck ◽

Jennifer Stinson

Keyword(s):

Social Support ◽

Randomized Controlled Trial ◽

Physical Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Self Determination ◽

Control Group ◽

Electronic Mentoring ◽

Youth With Disabilities ◽

Randomized Controlled

BACKGROUND Youth with disabilities are at high risk of unemployment compared with youth without disabilities. They often encounter challenges in accessing vocational programs that meet their needs. One promising approach that could help to address barriers that youth encounter while also enhancing social support is through electronic mentoring (e-mentoring). Although there is an increase in e-mentoring for youth with disabilities, little is known about its impact for youth with physical disabilities. OBJECTIVE This study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities. METHODS The Empowering Youth Towards Employment intervention was evaluated using a pilot randomized controlled trial (RCT). Youth, aged 15-21 years, with physical disabilities were randomly assigned to an intervention (ie, mentored) or control (ie, not mentored) group. Trained mentors (ie, near peers) with a physical disability led the online discussion forums and provided peer support and resources for 12 modules (1 topic per week over 12 weeks). Primary outcomes focused on self-determination, career maturity, and social support. We also explored program adherence and dosage, participant satisfaction, and areas for improvement. RESULTS A total of 13 youth (mean age 17.3 years, SD 1.88; 54%, 7/13 female) completed the RCT. In the intervention group (n=9), 56% (5/9) of the youth were females, and in the control group (n=4), 50% (2/4) of the youth were female. Participants reported satisfaction with the program and that it was feasible and acceptable. Participants’ mean engagement level with the program was 5.22 (SD 2.48) for the intervention group and 5.40 (SD 4.56) for controls. Participants in the intervention group demonstrated significant improvements in self-determination (t12=2.49; P<.04) compared with the control group. No adverse events were reported. CONCLUSIONS The Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities. CLINICALTRIAL ClinicalTrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc)

Download Full-text

Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽

10.2196/20747 ◽

2020 ◽

Vol 3 (1) ◽

pp. e20747

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

Download Full-text

Effect of dental intervention on improvements in metabolic syndrome patients: a randomized controlled clinical trial

BMC Oral Health ◽

10.1186/s12903-020-01373-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Midori Doke ◽

Yuriko Komagamine ◽

Manabu Kanazawa ◽

Maiko Iwaki ◽

Hiroyuki Suzuki ◽

...

Keyword(s):

Metabolic Syndrome ◽

Medical Information ◽

Controlled Trial ◽

Intervention Group ◽

University Hospital ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Dental Intervention ◽

Water Rate

Abstract Background Metabolic syndrome (MetS), caused by the accumulation of visceral fat, is considered a major cause of cardiovascular disease. This randomized controlled trial aimed to clarify the effect of dental intervention, including prosthodontics and/or periodontal treatment, combined with dietary and exercise guidance on MetS. Methods In total, 112 patients who met the Japanese waist circumference criteria of MetS were recruited. The intervention group (ITG) received dental intervention along with dietary and exercise guidance, while the control group (CTG) received dietary and exercise guidance alone. Three outcome measurements were obtained before intervention (BL), 1 month after intervention (1M), and 3 months after intervention (3M). Results Body water rate (p = 0.043) was significantly higher in ITG than in CTG at 1M. Simultaneously, fasting blood sugar level (p = 0.098) tended to be lower in ITG than in CTG. Lean mass (p = 0.037) and muscle mass (p = 0.035) were significantly higher and body weight (p = 0.044) significantly lower in ITG than in CTG at 3M. Body mass index (p = 0.052) tended to be lower in ITG than in CTG. Conclusions Dental intervention combined with lifestyle guidance may improve anthropometric status and reduce the risk of MetS. Trial registration University Hospital Medical Information Network Center Unique UMIN000022753. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026176.

Download Full-text

The effect of a care plan based on the Roy adaptation model on general health in hemodialysis patients; a randomized controlled clinical trial

Journal of Renal Injury Prevention ◽

10.34172/jrip.2020.11 ◽

2020 ◽

Vol 9 (2) ◽

pp. e11-e11

Author(s):

Monir Nobahar ◽

Mohadese Saffari ◽

Hassan Babamohamadi ◽

Nemat Sotodehasl ◽

Majid Mirmohammadkhani

Keyword(s):

Clinical Trial ◽

General Health ◽

Intervention Group ◽

Hemodialysis Patients ◽

Care Plan ◽

Controlled Clinical Trial ◽

Roy Adaptation Model ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Adaptation Model

Introduction: Evidence suggests that end-stage renal disease (ESRD) significantly affects general health in the patients, causing their general health to be poorer compared to the general population. The Roy adaptation model (RAM) is the best one for ESRD patients. Objectives: The present study aimed to determine the effect of a RAM-based care plan on general health in hemodialysis patients. Patients and Methods: This randomized controlled clinical trial conducted on 60 hemodialysis patients in Iran. The data collected using a demographic questionnaire and the general health questionnaire-28 (GHQ-28). In the intervention group, the Roy assessment form was completed and the RAM-based care plan was then trained in four group sessions over 4 weeks. Individual sessions were also held if required and patients followed-up for 2 weeks. The control group received only routine care. At the end of the follow-up, general health was re-assessed in the patients. The findings were analysed using t test, the chi-square test and the McNemar test. Results: Despite observing no significant differences between the two groups in terms of general health levels before the intervention (P=0.530), the difference was significant after the intervention (P=0.028), since the mean score of general health decreased by 4.07 in the intervention group compared to before the intervention (P=0.003). The intervention significantly affected the subscales of somatic symptoms (P=0.013), anxiety and insomnia (P=0.006), social dysfunction (P=0.016) and depression (P=0.031). Conclusion: The findings suggested the positive effects of using the RAM on general health in hemodialysis patients. The RAM is therefore recommended that be used as a holistic care approach to improving general health in these patients

Download Full-text

Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial (Preprint)

10.2196/preprints.20747 ◽

2020 ◽

Author(s):

Mahboube Davoudi ◽

Tahereh Najafi Ghezeljeh ◽

Farveh Vakilian Aghouee

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Clinical Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Patients With Heart Failure

BACKGROUND Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. OBJECTIVE The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. METHODS This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. RESULTS The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (<i>P</i><.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (<i>P</i><.001). CONCLUSIONS Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

Download Full-text

Does Additional Extracorporeal Shock Wave Therapy Improve the Effect of Isolated Percutaneous Radiofreqency Coblation in Patients with Insertional Achilles Tendinopathy? Study Protocol for A Randomized Controlled Clinical Trial

10.21203/rs.3.rs-35074/v1 ◽

2020 ◽

Author(s):

Yu-Jie Song ◽

Wen-Kai Xuan ◽

Ying-Hui Hua

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Achilles Tendinopathy ◽

Conclusive Evidence ◽

Secondary Outcome ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Extracorporeal Shock Wave ◽

Insertional Achilles Tendinopathy

Abstract Background: No conclusive evidence recommends a prior treatment for insertional Achilles tendinopathy (IAT). It is theorized that both percutaneous radiofreqency coblation and extracorporeal shockwave therapy (ESWT) relieve pain within the insertion. However, no clinical evidence shows that either treatment promote the regeneration of the tendon or if the combination of these 2 interventions offer better function and less pain than one therapy. Methods: The study is a randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients with insertional Achilles tendinopathy who are not satisfied with the effect of conservative treatment will be screened. A minimum of 38 patients will be enrolled after deciding to participate in the trial on an informed basis. Then the intervention group and the control group perform radial ESWT and sham-ESWT respectively at 6 months after percutaneous radiofreqency coblation. The primary outcome will be the Victorian Institute of Sports Assessment Achilles (VISA-A) Score. Secondary outcome measures will be Foot and Ankle Outcome Score (FAOS) scale, Visual Analogue Scale (VAS), Tegner Score, and MRI ultra-short echo time (UTE) T2* value. The assessments will occur in 6 months, 1 year, and 2 years post-operatively. The differences between 2 groups will be conducted as intention-to-treat basis. Discussion: We aim to investigate if radiofreqency coblation associated with ESWT can provide more encouraging imaging findings as well as functional and clinical outcomes regarding the treatment of the IAT comparing to the single radiofreqency coblation treatment.Trial registration: ChiCTR1800017898; Pre-results. Registered on 20 August 2018.

Download Full-text

Effectiveness of an overall progressive resistance strength program for improving the functional capacity of patients with rheumatoid arthritis: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215517698732 ◽

2017 ◽

Vol 31 (11) ◽

pp. 1482-1491 ◽

Cited By ~ 5

Author(s):

Felipe Martinelli Lourenzi ◽

Anamaria Jones ◽

Daniele Freitas Pereira ◽

João Henrique Costa Alves dos Santos ◽

Rita Nely Vilar Furtado ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Strength Training ◽

Functional Capacity ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Sf 36 ◽

Progressive Resistance

Objective: To evaluate the effectiveness of overall progressive resistance training in patients with rheumatoid arthritis. Design: Randomized controlled clinical trial with blinded assessor and intention-to-treat analysis. Setting: Outpatient clinics. Subjects: Sixty patients with rheumatoid arthritis according to the American College of Rheumatology criteria, aged between 18 and 65 years old, under stable medication and not performing regular physical activity were randomized into two groups: intervention group (IG) and control group (CG). Interventions: IG performed the progressive resistance strength training, twice a week, during 12 weeks. The training consists of exercising various muscle groups using a load of 50% and 70% of one repetition maximum. The load was reassessed and adjusted after six weeks of baseline. Both groups remained in conventional drug treatment during the study. Main measures: Patients were evaluated at baseline and after 6, 12, and 24 weeks, using HAQ and SF-36 questionnaires and strength. Results: Thirty-three patients in the CG and 27 in the IG were evaluated. The groups were homogeneous at baseline. Statistical and clinical improvement were found with better results for the IG in the HAQ questionnaire ( P=0.030), functional capacity (0=0.022) and pain ( P=0.027) domains of SF-36; and muscle strength for flexors of right and left knee ( P=0.005 and p=0.14), abductors of shoulder ( P=0.041) and extensors of right and left wrists ( P=0.003 and P= 0.005). Conclusions: This progressive resistance strength training improves physical function as well as grip and muscular strength of knee flexors, shoulder abductors and wrist extensors in patients with RA, without adverse effects.

Download Full-text