The Quality of Life, Perceived Stress and Coping Ways of Caregivers of Mentally Handicapped Individuals

Intellectual Disability Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790461
• Other study ID #: 80576354-050-99/254
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: February 2024
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 30, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

Other:
• Pre-post test
Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

Behavioral:
• face-to-face training + PMR exercise
4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling
• mobile health education + PMR exercise
To provide awareness and exercise with 8 weeks Roy adaptation model-based training and mobile application access with PMR exercise content
• face-to-face and mobile health education + PMR exercise
4 weeks face-to-face training based on Roy adaptation model + teaching PMR exercises and 4 weeks based training on Roy adaptation model and mobile application access with PMR exercise content

Locations

Country	Name	City	State
Turkey	Kafkas University-Ataturk Health Services Vocational School	Kars	Turkey/Kars
Turkey	Sakarya University Health Faculty of Health Sciences	Sakarya

Sponsors (2)

Lead Sponsor	Collaborator
Kafkas University	Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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.

Fernandez Sanchez H, Hernandez CBE, Sidani S, Osorio CH, Contreras EC, Mendoza JS. Dance Intervention for Mexican Family Caregivers of Children With Developmental Disability: A Pilot Study. J Transcult Nurs. 2020 Jan;31(1):38-44. doi: 10.1177/1043659619838027. Epub 2019 Apr 4. — View Citation

Najafi Ghezeljeh T, Kohandany M, Oskouei FH, Malek M. The effect of progressive muscle relaxation on glycated hemoglobin and health-related quality of life in patients with type 2 diabetes mellitus. Appl Nurs Res. 2017 Feb;33:142-148. doi: 10.1016/j.apnr.2016.11.008. Epub 2016 Nov 14. — View Citation

Novais PG, Batista Kde M, Grazziano Eda S, Amorim MH. The effects of progressive muscular relaxation as a nursing procedure used for those who suffer from stress due to multiple sclerosis. Rev Lat Am Enfermagem. 2016 Sep 1;24:e2789. doi: 10.1590/1518-8345.1257.2789. — View Citation

Ozgundondu B, Gok Metin Z. Effects of progressive muscle relaxation combined with music on stress, fatigue, and coping styles among intensive care nurses. Intensive Crit Care Nurs. 2019 Oct;54:54-63. doi: 10.1016/j.iccn.2019.07.007. Epub 2019 Jul 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Caregiver Quality of Life Questionnaire (AC-QoL)	Developed by Stephen Joseph et al. (2012), validity and reliability in Turkish by Gençer and Sengül, caregiver quality of life in 8 different areas (care giving, caring preference, patient care stress, financial issues, personal development, valuing, caregiving ability and caregiver satisfaction) is a questionnaire that provides the opportunity to evaluate. In scale evaluation, 0-40 points indicate "low quality of life", 41-80 points "average quality of life" and 81-120 points indicate "high quality of life" (Joseph et al. 2012; Gençer, 2020).	ten weeks
Primary	Perceived Stress Scale (PSS)	Scale developed by Cohen, Kamarcik and Mermelstein (Cohen at al., 1983). A total of 14 items were designed to measure how stressful certain situations in a person's life are perceived. PSS scores are between 0 and 56. A high score indicates a person's high perception of stress (Eskin et al., 2013). In the original form of the scale, the internal consistency Cronbach alpha coefficient was 0.84, and the test-retest reliability coefficient was determined as 0.85 as a result of two measurements performed two days apart (Cohen at al., 1983). Cronbach coefficient alpha was found 0.87 (Eskin et al., 2013) and 0.722 (Yimaz 2020) in the Turkish validity and reliability study.	ten weeks
Primary	The Questionnaire of Ways to Cope with Stress (SBÇYA)	The Coping Ways Questionnaire (WCQ) developed by Folkman and Lazarus was adapted into Turkish by Sahin and Durak (1995). The scale consists of five sub-dimensions: "confident", "optimistic", "helpless", "obedient" and "seeking social support". In the 30-item scale, the answers given for each item are in four-order evaluation (0- 30-70-100%) ranging from 0 to 100%.	ten weeks