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

NCT ID: NCT04790461

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-25

Study Completion Date

2022-01-30

Brief Summary

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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

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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.

Conditions

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Intellectual Disability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants were assigned to groups using the "simple randomization method". Participants were not informed of which group they were in. Automated computer-based randomization resulted in the implementation of the experiment with the scheduling scenario and confidential allocation of participants to one of the four intervention branches. The researcher was blind to all conditions until the participants started the computer program and the intervention began. Participants were also unaware of whether the group they were assigned to was an experimental or a control condition. In addition, researchers coding and analyzing data will be blind to randomization and interventions.

Study Groups

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1. experimental group: face to face education+PMR exercise

The education and PMR exercises prepared in line with the face-to-face Roy adaptation model will be applied. In groups of 8-10 people, the first 4 sessions in rehabilitation centers will last for the first 4 sessions, and then PMR exercises will be taught and applied (between the 2nd and the 5th weeks, they will be encouraged to do PGE twice at home). The next 4 weeks will be provided with PMR consultancy (3 times a week application / total 24 sessions of PMR application). PMR exercises will be given a follow-up schedule and the caregivers will be followed up by the caregivers themselves and the researchers.

Group Type EXPERIMENTAL

Pre-post test

Intervention Type OTHER

Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

face-to-face training + PMR exercise

Intervention Type BEHAVIORAL

4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling

2. experimental group: mobile health education + PMR exercise

Access to mobile applications will be provided for 8 weeks, including the Roy adaptation model-based training and PMR exercises, which include video and training presentations prepared by the consultant and researcher, as a power point presentation. PMR exercises will be uploaded to the system by uploading a follow-up schedule to the system, and it will be ensured that the person can follow himself / herself at least 3 times a week (24 sessions in total) and the researchers can follow the participants.

Group Type EXPERIMENTAL

Pre-post test

Intervention Type OTHER

Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

mobile health education + PMR exercise

Intervention Type BEHAVIORAL

To provide awareness and exercise with 8 weeks Roy adaptation model-based training and mobile application access with PMR exercise content

3rd experimental group: face to face and mobile health education + PMR exercise

4 sessions prepared in line with the Roy adaptation model face to face and held in rehabilitation centers, training in groups of 8-10 people, teaching PMR exercises and installing phone applications that can be accessed for 8 weeks), 8-week intervention including training (enabling them to do progressive relaxation exercises and access to training content) will be provided. . The PMR exercises will be uploaded to the system / given as a printout according to the caregiver's preference, and it will be ensured that the person can follow himself / herself at least 3 times a week (24 sessions in total) and the researchers watch the participant.

Group Type EXPERIMENTAL

Pre-post test

Intervention Type OTHER

Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

face-to-face and mobile health education + PMR exercise

Intervention Type BEHAVIORAL

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

Control group

Without applying any intervention, the post-test YBYKA, ASÖ and SBÇYA scales will be applied in the 10th week of the study. After all the tests for the study are measured and finished, they will be provided with training and relaxation exercises.

Group Type OTHER

Pre-post test

Intervention Type OTHER

Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

Interventions

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Pre-post test

Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)

Intervention Type OTHER

face-to-face training + PMR exercise

4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sakarya University

OTHER

Sponsor Role collaborator

Kafkas University

OTHER

Sponsor Role lead

Responsible Party

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Gönül GÖKÇAY

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gönül GÖKÇAY

Role: PRINCIPAL_INVESTIGATOR

Kafkas University-Ataturk Health Services Vocational School Kars, Turkey, 36500

Ayşe ÇEVİRME

Role: STUDY_DIRECTOR

Sakarya University Health Faculty of Health Science Sakarya, Turkey, 54100

Locations

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Kafkas University-Ataturk Health Services Vocational School

Kars, Turkey/Kars, Turkey (Türkiye)

Site Status

Sakarya University Health Faculty of Health Sciences

Sakarya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27598379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31371164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30947622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28096008 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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80576354-050-99/254

Identifier Type: -

Identifier Source: org_study_id

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