NCT04880941

Brief Summary

It is important to consider the needs of palliative care caregivers and to plan interventions for psychosocial problems.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

1 month

First QC Date

May 6, 2021

Last Update Submit

July 16, 2021

Conditions

Keywords

Progressive Relaxation ExerciseCoping With StressAnxiety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4 week

Secondary Outcomes (2)

  • Anxiety in Palliative Caregivers

    1 week

  • Anxiety in Palliative Caregivers

    4 week

Study Arms (2)

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

Behavioral: Progressive Relaxation Exercise

Control group

NO INTERVENTION

Routine maintenance will be applied

Interventions

In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.

Also known as: Control group
Progressive Relaxation Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Sabahattin Zain Universitiy

Istanbul, State, 34303, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28069156BACKGROUND
  • 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.

  • Turan 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.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Zülfünaz ÖZER, PhD

    Istanbul Sabahattin Zaim University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Progressive Relaxation Exercise and control group
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an experimental study with pre-test and post-test control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., Assistant Prof

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 11, 2021

Study Start

April 30, 2021

Primary Completion

June 10, 2021

Study Completion

June 30, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations