Technological Devices in Circumcision

September 29, 2025 updated by: Bedreddin Kalyenci, Adiyaman University

The Effect of Technological Devices on the Child's Pain and Anxiety Level in Circumcision Performed With Local Anesthesia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

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
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Circumcision for medical or religious reasons.

Exclusion Criteria:

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: circumcision by watching videos/playing games
Procedure: Technological device in circumcision
Circumcision is performed by watching a video/playing a game during the procedure in children who are circumcised.
No Intervention: circumcision without visual or verbal stimulation
Not providing any visual or verbal stimulation to circumcised children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of child anxiety and worry
Time Frame: immediately after the intervention/procedure/surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in anxiety and worry among parents.
Time Frame: immediately after the intervention/procedure/surgery
Anxiety levels will be assessed with scales to determine changes in anxiety. The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
immediately after the intervention/procedure/surgery

Collaborators and Investigators

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

Sponsor

Adiyaman 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)

January 20, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 24, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRÜ/24.21.25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 2 years after completion of the work

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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