Progressive relaxation with a therapeutic clown to reduce pre-surgery fear and anxiety in children
The Effect of Progressive Relaxation Exercises With Therapeutic Clown in Preoperative Period on Fear Anxiety and Physiological Parameters in Children
This trial tests whether progressive relaxation exercises led by a therapeutic clown before circumcision reduce fear, anxiety, and change vital signs in children aged 6–10.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | Male |
| Sponsor | Ataturk University Academic / other |
| Locations | 1 site (Erzurum) |
| Trial ID | NCT07525388 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolled children aged 6–10 undergoing elective circumcision and randomized them to three groups: progressive relaxation led by a therapeutic clown, progressive relaxation led by a nurse, or usual care. Fear, anxiety, and physiological parameters (heart rate, respiratory rate, blood pressure, and oxygen saturation) were measured before and after the preoperative intervention. Interventions were delivered in the preoperative area prior to surgery and outcomes compared changes between groups. No detailed sample size or longer-term follow-up was provided in the brief description.
Who should consider this trial
Good fit: Children aged 6–10 scheduled for elective circumcision who have no cognitive, vision, or hearing impairments and who are willing and available to participate at the hospital.
Not a fit: Children outside the 6–10 age range, those with cognitive or sensory impairments, those who withdraw consent, or those not undergoing elective circumcision are unlikely to benefit from this specific protocol.
Why it matters
Potential benefit: If successful, this approach could reduce children's preoperative fear and anxiety and help stabilize physiological signs before surgery.
How similar studies have performed: Prior small studies of therapeutic clowns and relaxation techniques have often shown reductions in pediatric preoperative anxiety, though results vary by setting and method.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Erzurum
- Paediatric Surgery Clinic, Atatürk University Health Research and Training Hospital — Erzurum, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sümeyye Ekici
- Email: ekicisumeyye@atauni.edu.tr
- Phone: +90442231111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.