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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06622369
Enrollment
105
Registered
2024-10-02
Start date
2024-09-19
Completion date
2025-09-19
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virtual Reality

Keywords

pain, anxiety, fear, virtual reality

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.

Interventions

OTHERVirtual 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

OTHERVirtual 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.

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomised controlled study

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fear assesed by Child Fear ScaleProcedure -Before the circumcisionThe 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.
Anxiety assesed by Children Anxiety Meter-StateProcedure -Before the circumcisionThe 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).
Visual Analog ScaleProcedure -After the circumcisionThe 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

MeasureTime frame
Children's heart rateProcedure -Before the circumcision
Children's respiratory rateProcedure -Before the circumcision
Children's oxygen saturationProcedure -Before the circumcision

Countries

Turkey (Türkiye)

Contacts

Primary ContactEliz Geçtan
elizgectan09@gmail.com05451342435

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026