Clinical trial NCT04790461: The Quality of Life, Perceived Stress and Coping Ways of Caregivers of Mentally Handicapped Individuals
Official title: The Effect of an Application Based on Training and Progressive Relaxation Exercises on the Quality of Life, Perceived Stress and Coping Ways of Caregivers of Mentally Handicapped Individuals: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intellectual Disability
Keywords: caregivers
model-based education
progressive relaxation exercises
quality of life
stress
mobile health
Intellectual Disability
Lead sponsor: Kafkas University
Sponsor class: OTHER
Collaborators: name: Sakarya University
First posted: 2021-03-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1. experimental group: face-to-face training + PMR exercise
2. experimental group: mobile health education + PMR exercise
3. experimental group: face-to-face and mobile health training + PMR exercise control group
Primary purpose: PREVENTION

Brief summary: Disability is a dynamic, multidimensional and diverse public health problem. Although the primary care burden of the disabled is mostly on mothers, caregivers cannot find little or no support socially and they have a high risk of experiencing physical and psychological health problems. In the studies carried out; Disabled caregivers reported higher and lower quality of life than healthy individuals' relatives with physical ailments such as asthma, arthritis, back pain, care burden, pain, insomnia, fatigue, depression, anxiety, stress. This study was planned to determine the effect of an application based on research, education and progressive relaxation exercises on the quality of life, perceived stress and coping strategies of caregivers of mentally disabled individuals.

HYPOTHESES OF THE RESEARCH H1:Face to face education and PGE exercises applied to mentally disabled individual caregivers have an effect on caregivers' quality of life, perceived stress and ways of coping with stress.

H2:Mobile application applied to mentally disabled caregivers and Education and PGE exercises have an effect on the quality of life of caregivers, their perceived stress and ways of coping with stress.

H3:The Face to face + Mobile Application education and PGE exercises applied to mentally disabled individual caregivers have an effect on the caregivers' quality of life, their perceived stress and ways of coping with stress.

Detailed description: Disability, a dynamic, multidimensional and diverse public health problem, can be acquired temporarily/chronicly or later in life due to congenital, acute illness and/or injury. Although the primary care burden of the disabled is mostly on mothers, caregivers cannot find little or no support socially and they have a high risk of experiencing physical and psychological health problems. In the studies carried out; Disabled caregivers reported higher and lower quality of life than healthy individuals' relatives with physical ailments such as asthma, arthritis, back pain, care burden, pain, insomnia, fatigue, depression, anxiety, stress. It was determined that 64.3% of mentally disabled caregivers experience severe stress. The measure that improves family caregivers' knowledge about effective and safe care strategies can reduce/prevent stress-related problems and improve their quality of life. Roy's Adaptation model (RAM) is one of the most widely used nursing models to cope with various diseases and problems, which is applied to improve the quality of life and reduce stress in caregivers. Progressive relaxation exercise (PGE), which is an excellent step to cope with stress and stress, has been recognized as an effective technique used in controlling muscle tension. Stress (Novais et al., 2016; Wicaturatmashudi\&Erman,2020; Özgündoğdu\&Metin, 2019; Fernández Sánchez et al., 2020) and quality of life (Ghezeljeh et al., 2017; Bahrami-Eyvanekey et al., 2017). As a part of the holistic care of children with mental disabilities, the needs and problems of their primary caregivers should be taken into consideration and solutions should be developed. At the end of this study, the effectiveness of structured interventions consisting of different learning styles (face-to-face, mobile application, face-to-face and mobile application; education + PGE exercises) and relaxing exercises that alleviate the physiological and psychological burden of care were tested, and it was the most effective in increasing the quality of life and reducing stress of caregivers of mentally disabled individuals. method will be determined. The method that has been proven to be effective will be supported by mobile application for the widespread access of mentally disabled individuals to their caregivers, to reach more target groups.

In this study, randomized controlled, 3 experimental, 1 control group, pretest-posttest experimental design will be used as research design. The study will be conducted with the caregivers of mentally disabled individuals rehabilitated in rehabilitation centers. The sample size was calculated as 34 individuals in each group (136 individuals) with the G-Power 3.1.9.2 power analysis program. The data will be obtained using the personal information form, adult caregiver quality of life questionnaire, perceived stress scale, ways of coping with stress questionnaire. The data will be evaluated using SPSS statistics 20 program and Statistical significance will be accepted as p\<.05.

Eligibility criteria: Inclusion Criteria:

* Having a child receiving education in a rehabilitation center in the province of Kars,
* Being a caregiver between the ages of 18-65,
* The individual he cared for should not have any disability other than mental disability
* Volunteering to participate in research,
* To be literate, to follow mobile application instructions,
* To have the knowledge to use the mobile application independently or to have another individual in the family who can help in this regard

Exclusion Criteria:

* Having a disability other than mental disability of the individual he cared for,
* Individuals with cognitive and physical dysfunction that will prevent interview or test application,
* Not wanting to participate in research.

Primary outcomes:
measure: Adult Caregiver Quality of Life Questionnaire (AC-QoL)
timeFrame: ten weeks
measure: Perceived Stress Scale (PSS)
timeFrame: ten weeks
measure: The Questionnaire of Ways to Cope with Stress (SBÇYA)
timeFrame: ten weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University-Ataturk Health Services Vocational School
state: Turkey/Kars
city: Sakarya
country: Turkey
facility: Sakarya University Health Faculty of Health Sciences
Study officials:
affiliation: Kafkas University-Ataturk Health Services Vocational School Kars, Turkey, 36500
name: Gönül GÖKÇAY
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University Health Faculty of Health Science Sakarya, Turkey, 54100
name: Ayşe ÇEVİRME
role: STUDY_DIRECTOR
References:
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citation: Bahrami-Eyvanekey Z, Ramezani-Badr F, Amini K, Karimian E. Comparison of the Effects of Guided Imagery and Progressive Muscle Relaxation on Quality of Life of Patients Undergoing the Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial. Iranian Journal of Nursing Research.2017; 12(3): 7-15.