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NCT Number: NCT07525388

The Effect of Progressive Relaxation Exercises With Therapeutic Clown

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.

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Key information

Conditions

Therapeutic Clown Anxiety Anxiety Disorders Fear Mental Disorders Relaxation Exercise Surgery

Age range

6 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Paediatric Surgery Clinic, Atatürk University Health Research and Training Hospital

Erzurum, 25240, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxation exercise group led by a therapeutic clown

Other

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.

The relaxation exercise group led by a research nurse

Other

Relaxation exercises help to reduce psychological pressure and tension in individuals by highlighting the difference between relaxation and muscle tension.

Primary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sümeyye Ekici

CONTACT

[email protected]

+90442231111

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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