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

NCT06622369 | Recruiting

• 1 other identifier: 1734
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality

Keywords

pain; anxiety; fear; virtual reality

Outcome Measures

Primary Outcomes (5)

• Fear assesed by Child Fear Scale

  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.

  Procedure -Before the circumcision

• Fear assesed by Child Fear Scale

  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.

  Procedure -After the circumcision

• Anxiety assesed by Children Anxiety Meter-State

  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).

  Procedure -Before the circumcision

• Anxiety assesed by Children Anxiety Meter-State

  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).

  Procedure -After the circumcision

• Visual Analog Scale

  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

  Procedure -After the circumcision

Secondary Outcomes (6)

• Children's heart rate

  Procedure -Before the circumcision

• Children's heart rate

  Procedure -After the circumcision

• Children's respiratory rate

  Procedure -Before the circumcision

• Children's respiratory rate

  Procedure -After the circumcision

• Children's oxygen saturation

  Procedure -Before the circumcision

Study Arms (3)

Experimental;:Virtual Reality-Game group

EXPERIMENTAL

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 of their choice 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.

Other: Virtual Reality-Game group

Experimental: Virtual Reality-Cartoon group

EXPERIMENTAL

Virtual Reality-Cartoon 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. VR will be disinfected before and after each use in terms of infection risk.

Other: Virtual Reality-Cartoon-video group

No Intervention

NO INTERVENTION

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

Interventions

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

Experimental;:Virtual Reality-Game group

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.

Experimental: Virtual Reality-Cartoon group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Chronic pain
• Eyeglass wear

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Bakircay University Cigli Training and Research Hospital

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Eliz Geçtan

CONTACT

05451342435; elizgectan09@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled study

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 2, 2024
• Study Start: September 19, 2024
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

TU (1)