Clinical trial NCT06622369: The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision
Official title: The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Keywords: pain
anxiety
fear
virtual reality
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 105
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Fear assesed by Child Fear Scale
timeFrame: Procedure -Before the circumcision
measure: Fear assesed by Child Fear Scale
timeFrame: Procedure -After the circumcision
measure: Anxiety assesed by Children Anxiety Meter-State
timeFrame: Procedure -Before the circumcision
measure: Anxiety assesed by Children Anxiety Meter-State
timeFrame: Procedure -After the circumcision
measure: Visual Analog Scale
timeFrame: Procedure -After the circumcision
Secondary outcomes:
measure: Children's heart rate
timeFrame: Procedure -Before the circumcision
measure: Children's heart rate
timeFrame: Procedure -After the circumcision
measure: Children's respiratory rate
timeFrame: Procedure -Before the circumcision
measure: Children's respiratory rate
timeFrame: Procedure -After the circumcision
measure: Children's oxygen saturation
timeFrame: Procedure -Before the circumcision
measure: Children's oxygen saturation
timeFrame: Procedure -After the circumcision
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Cigli Training and Research Hospital
Study officials:
References: