Palliative CareNCT04880941
Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress,Anxiety
A study testing Progressive Relaxation Exercise in people with Palliative Care, run by Istanbul Sabahattin Zaim University at 1 site in Turkey (Türkiye).
Trial summary
It is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Palliative Care
- What is being tested?
- Progressive Relaxation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2021to 30 Jun 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Sabahattin Zain Universitiy
Istanbul, State, 34303
About this study
Official title: 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.
Read the detailed description
Cognitive-behavioral methods, which may be applied as relaxation aids in controlling the anxiety levels.
- Conditions
- Palliative Care
- Being tested
- Progressive Relaxation Exercise
- Keywords
- Progressive Relaxation Exercise, Coping With Stress, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation ExerciseBehavioural
Also called Control group
In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Relaxation Exercise | Experimental | 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 Receives: Behavioral: Progressive Relaxation Exercise |
| Control group | No intervention | Routine maintenance will be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping With Stress in Palliative Caregivers
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.
Measured: 1 week
Coping With Stress in Palliative Caregivers
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.
Measured: 4 week
Secondary outcomes (2)
Anxiety in Palliative Caregivers
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.
Measured: 1 week
Anxiety in Palliative Caregivers
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.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start30 Apr 2021
- Primary completion10 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is an experimental study with pre-test and post-test control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Sabahattin Zaim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülfünaz ÖZER, Istanbul Sabahattin Zaim University
- Investigators
- Zülfünaz ÖZER, PhD, Study chair, Istanbul Sabahattin Zaim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880941
- Sponsor's protocol ID
- 2021/02
- Status last verified
- Jul 2021
- First submitted
- 6 May 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28069156Borji 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.
PubMed 29281868Turan GB, Ozer Z, Demir C. The Effect of Progressive Muscle Relaxation Exercises Applied to Caregivers of Palliative Care Patients on Stress Coping Styles and Anxiety Levels: A Randomised Controlled Trial. Nurs Open. 2025 Feb;12(2):e70149. doi: 10.1002/nop2.70149.
PubMed 39953943
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise Applied to Palliative Caregivers on Coping With Stress and Anxiety Variables
- ClinicalTrials.gov ID
- NCT04880941
- Acronym / sponsor ID
- 2021/02
- Conditions
- Palliative Care
- Keywords
- Progressive Relaxation Exercise, Coping With Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Sabahattin Zaim UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 May 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.
It is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems.
Detailed description
Cognitive-behavioral methods, which may be applied as relaxation aids in controlling the anxiety levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an experimental study with pre-test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Progressive Relaxation Exercise | Experimental | Behavioral: Progressive Relaxation ExerciseThe Progressive Relaxation Exercise will be held 7 days for 4 weeks, a total of twenty eight sessions. Each session is set as fifty minutes |
| Control group | No intervention | –Routine maintenance will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Progressive Relaxation ExerciseAlso: Control groupIn the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved. | Behavioural | Progressive Relaxation Exercise |
Primary outcome
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.
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.
2 secondary outcomes
Anxiety in Palliative Caregivers
Time frame: 1 week
Anxiety in Palliative Caregivers
Time frame: 4 week
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 22 Jul 2021.
- Background: PubMed 28069156Tsitsi 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.
- Results publication: PubMed 29281868Borji 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.
- Derived from this study: PubMed 39953943Turan GB, Ozer Z, Demir C. The Effect of Progressive Muscle Relaxation Exercises Applied to Caregivers of Palliative Care Patients on Stress Coping Styles and Anxiety Levels: A Randomised Controlled Trial. Nurs Open. 2025 Feb;12(2):e70149. doi: 10.1002/nop2.70149.
- Individual participant dataSharing planned: No
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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.
Zülfünaz ÖZER, PhD study chair
Istanbul Sabahattin Zaim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Relaxation Exercise in people with Palliative Care, run by Istanbul Sabahattin Zaim University at 1 site 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 4 inclusion and 1 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Coping With Stress in Palliative Caregivers (time frame: 1 week). The study lists 2 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 NCT04880941, which also lists 3 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 22 Jul 2021.