Virtual Reality Intervention in Children After Hypospadias Surgery

NCT07752680 | Completed

• 1 other identifier: E10840098-202.3.02-170
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the effect of virtual reality glasses use on pain, comfort, and psychosocial symptoms in children after hypospadias surgery.

Conditions

Pain; Comfort; Psychosocial Symptoms

Keywords

Pain; Hypospadias; Comfort; Psychosocial symptoms; Virtual reality headset

Outcome Measures

Primary Outcomes (2)

• wong-baker faces scale

  The assessment was conducted using the Wong-Baker Faces Scale. On the scale, the lowest score is "0" and the highest is "10." Pain intensity increases as the score rises. When administering the scale, an explanation is provided to the child using facial expressions, and the child is asked to select the expression that best reflects their condition. The scale scores are interpreted as follows: 0 = no pain; 2 = mild pain; 4 = some pain; 6 = distinct pain; 8 = severe pain; and 10 = unbearable pain.

  1 hour after surgery/before and after application/2 times a day/10-15 minutes

• pediatric comfort assessment scale

  The assessment was conducted using the pediatric comfort assessment scale. It evaluates 5 parameters: sounds, motor movements, performance, facial expressions and other. Each item is evaluated on a 5-point Likert scale from 0 to 4 (0/Not Available, 1/No, 2/Somewhat, 3/Moderate, 4/Strong) from bad to good. Higher scores indicate a higher level of comfort.

  1 hour after surgery/before and after application/2 times a day/10-15 minutes

Secondary Outcomes (1)

• Psychosocial symptom assessment scale for hospitalized children

  1 hour after surgery/before and after application/2 times a day/10-15 minutes

Study Arms (2)

control group

EXPERIMENTAL

routine clinical practice

Other: routine clinical practice

intervention group

EXPERIMENTAL

playing a 15-minute game through virtual reality glasses

Device: Virtual reality headset

Interventions

Virtual reality headset DEVICE

One hour after the hypospadias surgery was completed and the child arrived at the ward, the children in the intervention group were fitted with Meta Quest 3 VR headsets, the procedure of which had been explained to them beforehand. The "V-SPEEDWAY" car racing game was opened through the headsets, allowing the children to play the game continuously for approximately 15 minutes. During this 15-minute VR experience, no painful medical interventions such as dressing changes or catheter insertion were performed on the child; the child was completely focused on the virtual world.

intervention group

routine clinical practice OTHER

Children in the control group were not subjected to any technological or additional distracting procedures in the first hour after surgery; they only underwent routine clinical monitoring in the ward.

control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must provide written and verbal informed consent from their parents for participation in the study, and be male children aged 6-12 who have undergone hypospadias surgery.

You may not qualify if:

• Having an auditory, mental, neurological, or visual impairment/problem severe enough to prevent VR glasses use, using an additional analgesic outside of the standard protocol within the first hour after surgery, or experiencing nausea, dizziness, or excessive panic reactions related to the virtual reality glasses during the procedure.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (55)

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MeSH Terms

Conditions

Pain; Hypospadias

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Aysel Kokcu Dogan

  Faculty Member

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Asst. Prof.

Model Details: A randomized controlled trial.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: August 7, 2026
• Study Start: December 5, 2025
• Primary Completion: March 1, 2026
• Study Completion: June 30, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)