Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06622369

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

Location status: Recruiting

Location contact

Eliz Geçtan

CONTACT

[email protected]

05451342435

About this study

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".

  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Virtual Reality-Game group

Other

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

Virtual Reality-Cartoon-video group

Other

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 outcomes

  1. Fear assesed by Child Fear Scale

    Time frame: Procedure -Before the circumcision

    The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.

  2. Fear assesed by Child Fear Scale

    Time frame: Procedure -After the circumcision

    The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.

  3. Anxiety assesed by Children Anxiety Meter-State

    Time frame: Procedure -Before the circumcision

    The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).

  4. Anxiety assesed by Children Anxiety Meter-State

    Time frame: Procedure -After the circumcision

    The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).

  5. Visual Analog Scale

    Time frame: Procedure -After the circumcision

    The extremes of the line are 0 (no pain at all) and 10 (unbearable pain). In pain assessment with this scale, the child is asked to place a mark on a point between 0 and 10 to indicate the level of pain or to express it verbally

Secondary outcomes

  1. Children's heart rate

    Time frame: Procedure -Before the circumcision

  2. Children's heart rate

    Time frame: Procedure -After the circumcision

  3. Children's respiratory rate

    Time frame: Procedure -Before the circumcision

  4. Children's respiratory rate

    Time frame: Procedure -After the circumcision

  5. Children's oxygen saturation

    Time frame: Procedure -Before the circumcision

  6. Children's oxygen saturation

    Time frame: Procedure -After the circumcision

Study contacts

Contact information is provided by the study sponsor or research team.

Eliz Geçtan

CONTACT

[email protected]

05451342435

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

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.

Published trials that share one or more normalized conditions with this study.