NCT05807295

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 15, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 11, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 15, 2023

Last Update Submit

March 28, 2023

Conditions

Caregivers With a Child Followed up With a Cancer Diagnosis

Outcome Measures

Primary Outcomes (2)

  • coping with stress

    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

    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)

Study Arms (2)

Intervention

EXPERIMENTAL

caregivers receiving a relaxation program

Other: Relaxation Program

Control group

NO INTERVENTION

the group that did not receive any training

Interventions

Relaxation ProgramOTHER

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.

Also known as: The relaxation program for caregivers
Intervention

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozturk CS, Katikol E. Effect of mHealth-based relaxation program on stress coping and anxiety levels in mothers of children with cancer: A randomized controlled study. Patient Educ Couns. 2024 Jun;123:108247. doi: 10.1016/j.pec.2024.108247. Epub 2024 Mar 11.

    PMID: 38471311DERIVED

MeSH Terms

Interventions

Relaxation TherapyCaregivers

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gazi University

Study Record Dates

First Submitted

March 15, 2023

First Posted

April 11, 2023

Study Start

April 13, 2023

Primary Completion

July 30, 2023

Study Completion

August 1, 2023

Last Updated

April 11, 2023

Record last verified: 2023-03

Locations

TU(1)