Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test

NCT06401408 | Not Yet Recruiting

• 1 other identifier: ERU-NF-KB-01
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is determine the effect of virtual reality headsets on pain, anxiety, fear and physiological parameters in children aged 4-7 years who undergoing skin prick test. The main questions it amis to answer are: Virtual reality headsets effect on the pain that during the procedure Virtual reality headsets effect on the anxiety that occurs during the procedure Virtual reality headsets effect on the fear that occurs during the procedure Virtual reality headsets effect on physiological parameters (heart rate, blood pressure, respiratory rate) during the procedure

Conditions

Allergy

Keywords

allergy

Outcome Measures

Primary Outcomes (1)

• Children's Fear Scale (CFS)

  To conduct an initial investigation of the psychometric properties of the Children's Fear Scale (CFS; based on the adult Faces Anxiety Scale) with young school-age children.The Child Fear Scale (CFS) developed by McMurtry et al. is used to assess the fear levels of children aged 4-10 years. In the scale, 5 cartoon face pictures are used. Anxiety level is evaluated with numbers between "0" and "4". A score of "0" indicates "no anxiety" and a score of "4" indicates "severe anxiety". The validity and reliability of the scale was conducted by Ozalp-Gerceker et al. in 2018. The content validity index is 0.89.Support was found for interrater reliability and test retest reliability of the CFS for measuring children's fear during venipuncture.

  4 weeks

Secondary Outcomes (1)

• Children's Anxiety Meter-State (CAM-S)

  4 weeks

Study Arms (2)

case group

Before starting the skin prick test, the child and his/her family who meet the inclusion criteria of the study will be informed about the use of virtual reality headsets(VRH) and volunteer consent forms will be obtained. Before starting the test, the Introductory Characteristics Form for Children and Their Families and scales will be applied to the children and the child's physiological parameters will be taken. Then, the children will be fitted with an VRH and watched an animated film determined in line with the child's age group, developmental characteristics and expert opinions.After the child starts watching the video, skin prick test procedures will be initiated and the child will be allowed to watch the video until the test ends. After the test is completed, physiological parameters will be taken again and scales will be applied.

control group

No intervention/application will be performed on the children who will be included in the control group. The Introductory Characteristics of Children and Their Families Form and scales will be administered to the children in the control group simultaneously with the experimental group (in the form of pretest-posttest). Additionally, physiological parameters will be taken simultaneously with the experimental group.

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The population of the study will consist of children aged 4-7 years who underwent skin prick test between September 01, 2023 and March 01, 2024 in the Pediatric Allergy Outpatient Clinic of Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital. In the power analysis (effect size= 1.32 α= 0.05, β= 0.95) performed in GPower 3.1 with the findings of the study by Stassart and Giebels (2022), the sample size was determined as experimental (SGG) group=16 and control group=16. At the end of the study, power analysis will be calculated using pain scores and it will be decided whether the sample size is sufficient or not.

You may qualify if:

• Between the ages of 4-7,
• Does not have a chronic or genetic disease,
• No mental, visual or hearing impairment,
• No analgesics or sedatives were administered at least one hour before the test procedure,
• Both he and his parents are open to communication and cooperation,
• Children who both themselves and their parents volunteer to participate in the research and give verbal and written consent will be included.

You may not qualify if:

• Those who are outside the 4-7 age range,
• Having a chronic or genetic disease,
• Mentally, visually or hearing impaired,
• Applying analgesics and sedatives at least one hour before the test procedure,
• The child who cannot adapt to virtual reality glasses,
• Both he and his parents do not cooperate,
• Children who neither they nor their parents volunteer to participate in the research and who do not give verbal or written consent will not be included in the research.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital

Kayseri, Melikgazi, 38050, Turkey (Türkiye)

Location

Related Publications (9)

• McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.

  PMID: 21806301 RESULT

• Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.

  PMID: 24094126 RESULT

• Addab S, Hamdy R, Thorstad K, Le May S, Tsimicalis A. Use of virtual reality in managing paediatric procedural pain and anxiety: An integrative literature review. J Clin Nurs. 2022 Nov;31(21-22):3032-3059. doi: 10.1111/jocn.16217. Epub 2022 Jan 23.

  PMID: 35068011 RESULT

• Antunes J, Borrego L, Romeira A, Pinto P. Skin prick tests and allergy diagnosis. Allergol Immunopathol (Madr). 2009 May-Jun;37(3):155-64. doi: 10.1016/S0301-0546(09)71728-8. Epub 2009 Jul 23.

  PMID: 19769849 RESULT

• Barni S, Liccioli G, Sarti L, Giovannini M, Novembre E, Mori F. Immunoglobulin E (IgE)-Mediated Food Allergy in Children: Epidemiology, Pathogenesis, Diagnosis, Prevention, and Management. Medicina (Kaunas). 2020 Mar 4;56(3):111. doi: 10.3390/medicina56030111.

  PMID: 32143431 RESULT

• Backer V, Nolte H, Pedersen L, Dam N, Harving H. Unawareness and undertreatment of asthma: follow-up in a different geographic area in Denmark. Allergy. 2009 Aug;64(8):1179-84. doi: 10.1111/j.1398-9995.2009.01994.x. Epub 2009 Feb 20.

  PMID: 19243364 RESULT

• Bodtger U, Jacobsen CR, Poulsen LK, Malling HJ. Long-term repeatability of the skin prick test is high when supported by history or allergen-sensitivity tests: a prospective clinical study. Allergy. 2003 Nov;58(11):1180-6. doi: 10.1046/j.1398-9995.2003.00323.x.

  PMID: 14616131 RESULT

• Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.

  PMID: 30052655 RESULT

• Cheng Z, Yu S, Zhang W, Liu X, Shen Y, Weng H. Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Asia Pac J Oncol Nurs. 2022 Sep 28;9(12):100152. doi: 10.1016/j.apjon.2022.100152. eCollection 2022 Dec.

  PMID: 36389624 RESULT

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Fulya Tahan, Prof. Dr.

  responsible for medical procedures

  STUDY CHAIR

Central Study Contacts

Kazim Bagci

CONTACT

+905336573633; kazimbagci@erciyes.edu.tr

Emine Erdem, Prof. Dr.

CONTACT

+905326066277; emine@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: June 20, 2024
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)