NCT06793722

Brief Summary

It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. The research will start with hospitalization and end with a check-up after discharge.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 20, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

January 20, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

circumcision

Outcome Measures

Primary Outcomes (1)

  • change of child anxiety and worry

    Anxiety levels will be assessed with scales to determine changes in anxiety. Wong Baker Facial Pain Scale: " 0 " Very happy because no pain, " 1 " A little pain, " 2 " A little more pain, " 3 " More pain, " 4 " Quite a lot of pain, " 5 " The worst pain you can imagine. Situational Anxiety Scale: The scale, which has been translated into Turkish and adapted, consists of a total of 20 items. The highest score that can be obtained from the scale is 80, and the lowest is 20. Child fear scale:This scale includes 5 different facial expressions. This scale is scored between 0-4.

    immediately after the intervention/procedure/surgery

Secondary Outcomes (1)

  • Changes in anxiety and worry among parents.

    immediately after the intervention/procedure/surgery

Study Arms (2)

circumcision by watching videos/playing games

EXPERIMENTAL
Procedure: Technological device in circumcision

circumcision without visual or verbal stimulation

NO INTERVENTION

Not providing any visual or verbal stimulation to circumcised children

Interventions

Circumcision is performed by watching a video/playing a game during the procedure in children who are circumcised.

circumcision by watching videos/playing games

Eligibility Criteria

Age6 Years - 18 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Circumcision for medical or religious reasons.

You may not qualify if:

  • Children with chronic diseases.
  • Children with genital medical problems.
  • Children with mental and communication disabilities and their parents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University

Adıyaman, 02400, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

January 20, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within 2 years after completion of the work

Locations