Effect of Progressive Muscle Relaxation on Parental Anxiety (PMR-PA)

August 31, 2026 updated by: Duygu ALTUNTAŞ, Akdeniz University

The Effect of Progressive Muscle Relaxation Exercises on Anxiety Among Parents of Children With Cancer: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of progressive muscle relaxation exercises on anxiety levels among parents who are the primary caregivers of children diagnosed with cancer and receiving inpatient treatment. A total of 112 parents will be randomly assigned to either the intervention or control group. Parents in the intervention group will participate in researcher-led progressive muscle relaxation sessions. Anxiety will be assessed using the State Anxiety Inventory (STAI-I). The study will be conducted at the Pediatric Hematology-Oncology Clinic of Akdeniz University Hospital in Antalya, Türkiye.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Parents of children diagnosed with cancer may experience substantial anxiety throughout their child's diagnosis and treatment. Progressive muscle relaxation is a nonpharmacological technique involving the systematic tensing and relaxing of major muscle groups combined with deep breathing. Eligible parents will be randomly allocated in equal numbers to the intervention or control group using a computer-generated randomization sequence. The intervention will be delivered individually in a private clinical education room. Participants will progressively tense and relax the muscles of the face, neck, shoulders, chest, abdomen, legs, and feet. Each muscle group will be tensed for 5 seconds and relaxed for 10 seconds while participants practice deep breathing and visualize a wave of relaxation throughout the body. Anxiety will be assessed using the State Anxiety Inventory (STAI-I), and changes in anxiety scores will be compared between the groups.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being the parent and primary caregiver of a child diagnosed with cancer
  • The child having been diagnosed with cancer within the previous 12 months
  • The child currently receiving inpatient treatment in the study clinic
  • Being able to communicate without hearing or speech-related barriers
  • Being able to understand and answer the study questions
  • Providing written informed consent

Exclusion Criteria:

  • Not meeting any of the inclusion criteria
  • Withdrawing consent at any time

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
Experimental: Progressive Muscle Relaxation
Participants will receive two individual progressive muscle relaxation sessions in a private clinical education room over two weeks. Each session will last approximately 15 minutes and will be conducted once weekly.
Behavioral: Progressive Muscle Relaxation
Participants will receive routine clinical care and will not participate in progressive muscle relaxation sessions during the study period.
No Intervention: Control
Participants in the control group will receive routine care provided by the clinic and will not participate in progressive muscle relaxation sessions during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in State Anxiety
Time Frame: 2 weeks
State anxiety will be measured using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S). The subscale contains 20 items and yields a total score ranging from 20 to 80. Higher scores indicate higher state anxiety.
2 weeks

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Duygu Altuntaş, PhD, Akdeniz 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 (Estimated)

August 15, 2026

Primary Completion (Estimated)

July 20, 2027

Study Completion (Estimated)

July 20, 2027

Study Registration Dates

First Submitted

August 10, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBAEK-976

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.

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