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

Sponsor
Gazi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05807295
Collaborator
(none)
50
1
2
3.6
13.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Relaxation Program
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.
Anticipated Study Start Date :
Apr 13, 2023
Anticipated Primary Completion Date :
Jul 30, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
  • No Intervention: Control group

    the group that did not receive any training

    Outcome Measures

    Primary Outcome Measures

    1. coping with stress [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.

    2. Anxiety [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gazi University Ankara Turkey 06560

    Sponsors and Collaborators

    • Gazi University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Çiğdem Sarı Öztürk, Gazi University, Gazi University
    ClinicalTrials.gov Identifier:
    NCT05807295
    Other Study ID Numbers:
    • 1503
    First Posted:
    Apr 11, 2023
    Last Update Posted:
    Apr 11, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2023