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

NCT04790461 | Completed

• 1 other identifier: 80576354-050-99/254
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Intellectual Disability

Keywords

caregivers; model-based education; progressive relaxation exercises; quality of life; stress; mobile health; Intellectual Disability

Outcome Measures

Primary Outcomes (3)

• Adult Caregiver Quality of Life Questionnaire (AC-QoL)

  Developed by Stephen Joseph et al. (2012), validity and reliability in Turkish by Gençer and Şengül, 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

• Perceived Stress Scale (PSS)

  Scale developed by Cohen, Kamarcık 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 (Yımaz 2020) in the Turkish validity and reliability study.

  ten weeks

• The Questionnaire of Ways to Cope with Stress (SBÇYA)

  The Coping Ways Questionnaire (WCQ) developed by Folkman and Lazarus was adapted into Turkish by Şahin 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

Study Arms (4)

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

EXPERIMENTAL

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.

Other: Pre-post test; Behavioral: face-to-face training + PMR exercise

2. experimental group: mobile health education + PMR exercise

EXPERIMENTAL

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.

Other: Pre-post test; Behavioral: mobile health education + PMR exercise

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

EXPERIMENTAL

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.

Other: Pre-post test; Behavioral: face-to-face and mobile health education + PMR exercise

Control group

OTHER

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.

Other: Pre-post test

Interventions

Pre-post test OTHER

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

1. experimental group: face to face education+PMR exercise; 2. experimental group: mobile health education + PMR exercise; 3rd experimental group: face to face and mobile health education + PMR exercise; Control group

face-to-face training + PMR exercise BEHAVIORAL

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

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

mobile health education + PMR exercise BEHAVIORAL

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

2. experimental group: mobile health education + PMR exercise

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

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafkas University: lead
• Sakarya University: collaborator

Study Sites (2)

Kafkas University-Ataturk Health Services Vocational School

Kars, Turkey/Kars, 36500, Turkey (Türkiye)

Location

Sakarya University Health Faculty of Health Sciences

Sakarya, 54100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27598379 BACKGROUND

• 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.

  PMID: 31371164 BACKGROUND

• 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.

  PMID: 30947622 BACKGROUND

• 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.

  PMID: 28096008 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Gönül GÖKÇAY

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

  PRINCIPAL INVESTIGATOR

• Ayşe ÇEVİRME

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 10, 2021
• Study Start: November 25, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 30, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)