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Completed

NCT Number: NCT07752680

Virtual Reality Intervention in Children After Hypospadias Surgery

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.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

This research was conducted as a randomized controlled trial, with a sample consisting of 62 pediatric patients (intervention group = 31, control group = 31) undergoing hypospadias surgery. Virtual reality headsets were administered to the intervention group postoperatively, while the control group received routine care. Data were collected using a Descriptive Information Form, the Wong-Baker FACES Scale, the Pediatric Comfort Assessment Scale, and the Psychosocial Symptom Identification Scale for Hospitalized Children. Data were analyzed using the IBM SPSS Statistics 22.0 software package. Descriptive statistics, independent samples t-test, chi-square test, and mixed-design repeated measures analysis were employed for data analysis. Statistical significance was set at p<0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. wong-baker faces scale

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

    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.

  2. pediatric comfort assessment scale

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

    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.

Secondary outcomes

  1. Psychosocial symptom assessment scale for hospitalized children

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

    The assessment was conducted using the Psychosocial Symptom Identification Scale for Hospitalized Children.

    Each item in the 24-item, 3-point Likert-type scale was evaluated as "never," "sometimes," or "frequently" and scored as 0, 1, and 2, respectively. The maximum score obtainable on the scale is 48, and the minimum score is 0. A high scale score indicates the presence of psychosocial problems in the hospitalized child.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

The Effect of Virtual Reality Headset Use on Pain, Comfort, and Psychosocial Symptoms in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2026
Registry last updated
Aug 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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