- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880941
Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress,Anxiety
July 16, 2021 updated by: Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
The Effect of Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress and Anxiety Variables
It is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cognitive-behavioral methods, which may be applied as relaxation aids in controlling the anxiety levels.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
State
-
Istanbul, State, Turkey, 34303
- Istanbul Sabahattin Zain Universitiy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To be able to communicate adequately
- Not having psychiatric problems
- Volunteering to participate in research
- Caregivers whose patients will be in bed for at least 4 weeks
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Routine maintenance will be applied
|
|
|
Experimental: Progressive Relaxation Exercise
The Progressive Relaxation Exercise will be held 7 days for 4 weeks, a total of twenty eight sessions.
Each session is set as fifty minutes
|
In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping With Stress in Palliative Caregivers
Time Frame: 1 week
|
Stress Coping Styles Scale-The minimum score to be obtained from the scale is 30, and the maximum score is 120.
The high scores indicate that the person copes effectively with stress.
|
1 week
|
|
Coping With Stress in Palliative Caregivers
Time Frame: 4 week
|
Stress Coping Styles Scale-The minimum score to be obtained from the scale is 30, and the maximum score is 120.
The high scores indicate that the person copes effectively with stress.
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety in Palliative Caregivers
Time Frame: 1 week
|
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983).
It can be used in clinical settings to diagnose anxiety.
It also is often used in research as an indicator of caregiver distress.
Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety.
State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure."
Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person."
All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always").
Higher scores indicate greater anxiety.
|
1 week
|
|
Anxiety in Palliative Caregivers
Time Frame: 4 week
|
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983).
It can be used in clinical settings to diagnose anxiety.
It also is often used in research as an indicator of caregiver distress.
Form Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety.
State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure."
Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person."
All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always").
Higher scores indicate greater anxiety.
|
4 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tsitsi T, Charalambous A, Papastavrou E, Raftopoulos V. Effectiveness of a relaxation intervention (progressive muscle relaxation and guided imagery techniques) to reduce anxiety and improve mood of parents of hospitalized children with malignancies: A randomized controlled trial in Republic of Cyprus and Greece. Eur J Oncol Nurs. 2017 Feb;26:9-18. doi: 10.1016/j.ejon.2016.10.007. Epub 2016 Nov 18.
- Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2021
Primary Completion (Actual)
June 10, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
May 6, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 11, 2021
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2021/02 (Avrasya University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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