The Effect of Progressive Relaxation Exercises With Therapeutic Clown

April 7, 2026 updated by: Sümeyye EKİCİ, Ataturk University

The Effect of Progressive Relaxation Exercises With Therapeutic Clown in Preoperative Period on Fear Anxiety and Physiological Parameters in Children

This study was conducted to investigate the effects of progressive relaxation exercises, performed with the assistance of a therapeutic clown during the pre-operative period, on fear, anxiety and physiological parameters in children. This randomised controlled trial included children aged 6-10 years undergoing circumcision surgery. The children were randomised into three groups: a progressive relaxation exercise group led by a therapeutic clown, a progressive relaxation group led by a nurse, and a control group. Fear, anxiety and physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation) were assessed before and after the procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

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 Contact

Study Locations

  • Turkey (Türkiye)
      • Erzurum, Turkey (Türkiye), 25240
        • Recruiting
        • Paediatric Surgery Clinic, Atatürk University Health Research and Training Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 6 and 10 years,
  • Willing to participate in the study,
  • Admitted to the clinic for elective circumcision surgery,
  • Accessible prior to surgery,
  • With no cognitive impairments,
  • With no vision or hearing problems were included in the study.

Exclusion Criteria:

  • Children who wished to withdraw from the study during the study period were excluded.

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
Routine nursing care
Experimental: Experimental 1
Relaxation exercise group with a therapeutic clown
Other: Relaxation exercise group led by a therapeutic clown
Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and tension. The therapeutic clown facilitates the release of endorphins, thereby promoting relaxation in situations that cause psychological tension. The combination of the two can create a synergistic effect.
Experimental: Experimental 2
Relaxation exercise group led by a research nurse
Other: The relaxation exercise group led by a research nurse
Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and muscle tension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Anxiety Scale
Time Frame: up to 1 year
The Children's Anxiety Scale - State Anxiety Scale measures state anxiety in children. The CAS-S (State Anxiety) is designed in the form of a thermometer. It consists of a bulb at the bottom and horizontal lines extending upwards. Each horizontal line represents one point, and the thermometer has a total of 10 points.
up to 1 year
Children's Fear Scale
Time Frame: up to 1 year
The Paediatric Fear Scale is used to measure fear in children undergoing painful medical procedures. The Paediatric Fear Scale is a 0-4 scale featuring five faces ranging from a neutral expression (0 = no anxiety) to a fearful face (4 = severe anxiety).
up to 1 year

Collaborators and Investigators

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

Sponsor

Ataturk 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 (Actual)

March 25, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD Thesis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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