Intellectual DisabilityNCT04790461
The Quality of Life, Perceived Stress and Coping Ways of Caregivers of Mentally Handicapped Individuals
A study testing Pre-post test, face-to-face training + PMR exercise and mobile health education + PMR exercise in people with Intellectual Disability, run by Kafkas University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Pre-post test, face-to-face training + PMR exercise and mobile health education + PMR exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Nov 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kafkas University-Ataturk Health Services Vocational School
Kars, Turkey/Kars, 36500
Sakarya University Health Faculty of Health Sciences
Sakarya, 54100
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- Pre-post test, face-to-face training + PMR exercise, mobile health education + PMR exercise, face-to-face and mobile health education + PMR exercise
- Keywords
- caregivers, model-based education, progressive relaxation exercises, quality of life, stress, mobile health, Intellectual Disability
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-post testOther
Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)
face-to-face training + PMR exerciseBehavioural
4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling
mobile health education + PMR exerciseBehavioural
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 exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Pre-post test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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%.
Measured: ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start25 Nov 2020
- Primary completion1 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya University
- Responsible party
- Principal investigator, Gönül GÖKÇAY, Kafkas University
- Investigators
- Gönül GÖKÇAY, Principal investigator, Kafkas University-Ataturk Health Services Vocational School Kars, Turkey, 36500Ayşe ÇEVİRME, Study director, Sakarya University Health Faculty of Health Science Sakarya, Turkey, 54100
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790461
- Sponsor's protocol ID
- 80576354-050-99/254
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This protocol study is a doctoral thesis. Therefore, the process may take longer and there may be plagiarism at the article stage. Only the name of the study can be shared with other researchers. Please let's hide the rest of the protocol publication, I wish you the best of luck.
Publications
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.
PubMed 27598379Ozgundondu 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.
PubMed 31371164Fernandez 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.
PubMed 30947622Najafi 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.
PubMed 28096008Bahrami-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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04790461
- Acronym / sponsor ID
- 80576354-050-99/254
- Conditions
- Intellectual Disability
- Keywords
- caregivers, model-based education, progressive relaxation exercises, quality of life, stress, mobile health, Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Collaborators
- Sakarya University
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| 1. experimental group: face to face education+PMR exercise | Experimental | Other: Pre-post test, Behavioral: face-to-face training + PMR exerciseThe 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. |
| 2. experimental group: mobile health education + PMR exercise | Experimental | Other: Pre-post test, Behavioral: mobile health education + PMR exerciseAccess 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. |
| 3rd experimental group: face to face and mobile health education + PMR exercise | Experimental | Other: Pre-post test, Behavioral: face-to-face and mobile health education + PMR exercise4 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. |
| Control group | Other | Other: Pre-post testWithout 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-post testAdult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ) | Other | 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 exercise4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling | Behavioural | 1. experimental group: face to face education+PMR exercise |
| mobile health education + PMR exerciseTo provide awareness and exercise with 8 weeks Roy adaptation model-based training and mobile application access with PMR exercise content | Behavioural | 2. experimental group: mobile health education + PMR exercise |
| face-to-face and mobile health education + PMR exercise4 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 | Behavioural | 3rd experimental group: face to face and mobile health education + PMR exercise |
Primary outcome
Adult Caregiver Quality of Life Questionnaire (AC-QoL)
Time frame: ten weeks
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).
Perceived Stress Scale (PSS)
Time frame: ten weeks
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.
The Questionnaire of Ways to Cope with Stress (SBÇYA)
Time frame: ten weeks
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 27598379Novais 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.
- Background: PubMed 31371164Ozgundondu 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.
- Background: PubMed 30947622Fernandez 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.
- Background: PubMed 28096008Najafi 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.
- BackgroundBahrami-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.
- Individual participant dataSharing planned: No. This protocol study is a doctoral thesis. Therefore, the process may take longer and there may be plagiarism at the article stage. Only the name of the study can be shared with other researchers. Please let's hide the rest of the protocol publication, I wish you the best of luck.
Related trials for Intellectual Disability
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
RecruitingObservational study
Genome Medical Sequencing for Gene Discovery
Intellectual Disabilities, Congenital Anomaly
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gönül GÖKÇAY principal investigator
Kafkas University-Ataturk Health Services Vocational School Kars, Turkey, 36500
Ayşe ÇEVİRME study director
Sakarya University Health Faculty of Health Science Sakarya, Turkey, 54100
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-post test, face-to-face training + PMR exercise and mobile health education + PMR exercise in people with Intellectual Disability, run by Kafkas University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Caregiver Quality of Life Questionnaire (AC-QoL) (time frame: ten weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790461, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.