The Effect of Progressive Relaxation Exercises With Therapeutic Clown
1 other identifier
interventional
162
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 7, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
CompletedJuly 7, 2026
October 1, 2025
1 year
April 7, 2026
July 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Children's Anxiety Scale
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
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
Study Arms (3)
Therapeutic clown
EXPERIMENTALRelaxation exercise group with a therapeutic clown
Nurse group
EXPERIMENTALRelaxation exercise group led by a research nurse
Routine nursing care group
NO INTERVENTIONRoutine nursing care
Interventions
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.
Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and muscle tension.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children who wished to withdraw from the study during the study period were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Paediatric Surgery Clinic, Atatürk University Health Research and Training Hospital
Erzurum, 25240, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
April 7, 2026
First Posted
April 13, 2026
Study Start
March 25, 2025
Primary Completion
April 1, 2026
Study Completion
June 30, 2026
Last Updated
July 7, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share