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Recruiting NCT06622369

The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision

No phase Interventional Virtual Reality

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality-Game group, Virtual Reality-Cartoon-video group.
Who it may be relevant to
Registry conditions: Virtual Reality. Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision: A Randomized Controlled Study

Overview

The aim of this study is to investigate the effect of virtual reality and cartoons and games on the anxiety, fear and post-procedural pain levels of children aged 7-12 years who will undergo circumcision. The population of the study will consist of children aged 7-12 years who are planned to undergo circumcision in the pediatric urology clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between September 2024 and September 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians and themselves agree to participate in the study. Descriptive Characteristics Form, Vital Symptom Form, Child Fear Scale, Child Anxiety Scale-Disposition (CAS-D) and Child Fear Scale will be used to collect the data.

Detailed description

Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.

Virtual Reality-Cartoons-Video group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. In terms of infection risk, VR will be disinfected before and after each use.

Control group Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.

Data Collection Phase 1: The study will start after ethics committee and institutional permissions are obtained. The researcher will inform the children and their parents about the study and the verbal and written consent of the participants will be obtained. Children who will undergo circumcision will be randomly assigned to the VR groups or the control group.

Phase 2: "Descriptive Characteristics Form", 'Child Fear Scale', 'Child Anxiety Scale-Conditionality (CAS-D)' will be completed for children in all groups before the circumcision procedure.

Phase 3: Children in the VR-game group will be asked to play a game of their choice for 10-15 minutes before the procedure. Children in the VR-cartoon-video group will be asked to watch a cartoon of their choice for 10-15 minutes.

Stage 4: Before the procedure, the physiologic parameters of the children in all groups will be recorded on the "Vital Signs Record Form".

5\. After the procedure, "Child Fear Scale", "Child Anxiety Scale-Conditioning (CAS-D)" and "Visual Analog Scale" and "Life Findings Record Form" will be filled out for the children in all groups.

Interventions

  • Other Virtual Reality-Game group
    Children in the play group will be allowed to choose a game that is compatible with virtual reality. Children in this group will be allowed to play the game they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use
  • Other Virtual Reality-Cartoon-video group
    Children in the cartoon-video group will be allowed to choose a cartoon they want compatible with virtual reality. Children in this group will be allowed to watch the cartoon they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.

Primary outcome measures

  • Fear assesed by Child Fear Scale [Time frame: Procedure -Before the circumcision]
  • Fear assesed by Child Fear Scale [Time frame: Procedure -After the circumcision]
  • Anxiety assesed by Children Anxiety Meter-State [Time frame: Procedure -Before the circumcision]
  • Anxiety assesed by Children Anxiety Meter-State [Time frame: Procedure -After the circumcision]
  • Visual Analog Scale [Time frame: Procedure -After the circumcision]
Secondary outcome measures (6)
  • Children's heart rate [Time frame: Procedure -Before the circumcision]
  • Children's heart rate [Time frame: Procedure -After the circumcision]
  • Children's respiratory rate [Time frame: Procedure -Before the circumcision]
  • Children's respiratory rate [Time frame: Procedure -After the circumcision]
  • Children's oxygen saturation [Time frame: Procedure -Before the circumcision]
  • Children's oxygen saturation [Time frame: Procedure -After the circumcision]

Eligibility criteria

Inclusion criteria

  • Children between the ages of 7 and 12,
  • The parent/legal guardian or the child himself/herself agrees to participate in the study
  • Has not undergone any surgical operation before
  • He was hospitalized for a circumcision
  • No communication problems (visual, hearing, mental)

Exclusion criteria

  • Chronic pain
  • Eyeglass wear

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Izmir Bakircay University Cigli Training and Research Hospital — Izmir

Identifiers

NCT: NCT06622369 · 1734

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗