Anxiety Clinical Trial
Official title:
The Effect of Immersive Virtual Reality and Music on Anxiety, Fear, and Pain During Circumcision Surgery in Children: A Randomized Controlled Trial
Verified date | February 2024 |
Source | Afyonkarahisar Health Sciences University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this randomized controlled trial is to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery. The main question[s] it aims to answer are: 1. Are immersive virtual reality and music interventions effective in reducing children's anxiety and fear levels during circumcision surgery? 2. Are immersive virtual reality and music interventions effective in reducing children's pain levels during circumcision surgery? There were three groups in the study: control group (n:24), immersive virtual reality group (n:24), and music group (n:24). The control group did not undergo any intervention and only the routine procedure of the clinic was performed. The participants in the immersive virtual reality group played an interactive video game. The participants in the music group listened to music of their preference.
Status | Completed |
Enrollment | 72 |
Est. completion date | July 15, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 6 Years to 8 Years |
Eligibility | Inclusion Criteria: - Circumcision in a pediatric surgery clinic - Agreeing to participate in the study - Having no visual and hearing problems, having no history of surgical intervention, and having no chronic pain or mental health problems Exclusion Criteria: - Presence of contraindications for the procedure (hypospadias, epispadias, bleeding disorders, anatomical disorders), - Use of any painkillers 24 hours before the procedure, - Presence of communication problems. |
Country | Name | City | State |
---|---|---|---|
Turkey | Afyonkarahisar Health Science University Health Science Faculty | Afyonkarahisar |
Lead Sponsor | Collaborator |
---|---|
Afyonkarahisar Health Sciences University |
Turkey,
Buyuk ET, Odabasoglu E, Uzsen H, Koyun M. The effect of virtual reality on Children's anxiety, fear, and pain levels before circumcision. J Pediatr Urol. 2021 Aug;17(4):567.e1-567.e8. doi: 10.1016/j.jpurol.2021.04.008. Epub 2021 Apr 21. — View Citation
Gezginci E, Suluhan D, Caliskan MB. Is tablet-based interactive distraction effective on pain and anxiety during circumcision in children? A randomized controlled trial. Turk J Urol. 2021 Nov;47(6):518-525. doi: 10.5152/tud.2021.21228. — View Citation
Luo W, Chen C, Zhou W, Cao A, Zhu W, Zhou Y, Xu Z, Wang J, Zhu B. Biophilic virtual reality on children's anxiety and pain during circumcision: A randomized controlled study. J Pediatr Urol. 2023 Apr;19(2):201-210. doi: 10.1016/j.jpurol.2022.10.023. Epub 2022 Oct 20. — View Citation
Suzan OK, Sahin OO, Baran O. Effect of Puppet Show on Children's anxiety and pain levels during the circumcision operation: A randomized controlled trial. J Pediatr Urol. 2020 Aug;16(4):490.e1-490.e8. doi: 10.1016/j.jpurol.2020.06.016. Epub 2020 Jun 20. — View Citation
Yeniay D, Tamdo An L, Yucak Ozdemir A, Ak An LO, Kay R SU. Effects of Videos and Therapeutic Music on Preoperative Anxiety and Postoperative Anxiety and Pain Levels in Boys Who Undergo Circumcision. J Perianesth Nurs. 2023 Dec;38(6):918-924. doi: 10.1016/j.jopan.2023.04.007. Epub 2023 Aug 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Statistical difference between groups about anxiety scores | Implementation of interventions aimed at reducing anxiety in experimental groups.
Children's Anxiety Meter-Scale:This scale is used in clinical settings to assess children's anxiety during invasive procedures. Scores obtained from the scale range from 0 to 10. |
During the procedure approximately 10 minutes | |
Primary | Statistical difference between groups about fear scores | Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale:This scale is used in clinical settings to assess children's fear during invasive procedures.The scale consists of five gender-neutral facial expressions, ranging from neutral on the far left to extremely fearful on the far right. The evaluation of facial expressions ranges between 0-4 points. | During the procedure approximately 10 minutes | |
Primary | Statistical difference between groups about pain scores | Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Faces Pain Rating Scale:This scale was developed by Wong and Baker to evaluate pain in children aged 3-18. Scores on the numerical rating scale range from 0 to 10. The scale shows a series of faces ranging from a smiling face (0=very happy/no pain) to a crying face (10=high pain) | During the procedure approximately 10 minutes |
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