The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.

March 28, 2023 updated by: Çiğdem Sarı Öztürk, Gazi University
This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Turkey
      • Ankara, Turkey, 06560
        • Gazi University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • The child has received cancer treatment for at least two months,
  • Those who have internet access on their smartphone or computer
  • Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)

Exclusion Criteria:

  • Those whose children/caregivers are in the terminal period,
  • Those whose child/caregiver has not received chemotherapy treatment,
  • Those who take medication for anxiety or use one of the complementary medicine approaches.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
the group that did not receive any training
Experimental: Intervention
caregivers receiving a relaxation program
Other: Relaxation Program
The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Videos will be sent to caregivers' social media accounts. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications.
Other Names:
  • The relaxation program for caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
coping with stress
Time Frame: Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)
The scale is a 23-item self-report measure of anxiety using a 5-point Likert-type scale. The scale does not have a cut-off point. The higher the score obtained from the scale, the better the coping is determined.
Change from Baseline level of Coping with stress to 8 weeks (change is being assessed)
Anxiety
Time Frame: Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)
The scale is a 20-item self-report measure of anxiety using a 4-point Likert-type scale (from 0 to 3 points) for each item. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety.
Change from Baseline level of Spielberger State-Trait Anxiety to 8 weeks (change is being assessed)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

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 (Anticipated)

April 13, 2023

Primary Completion (Anticipated)

July 30, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Caregivers With a Child Followed up With a Cancer Diagnosis

Clinical Trials on Relaxation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe