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

Allergy Clinical Trial

Official title:

Effect of Virtual Reality Headsets on Pain, Anxiety, Fear and Physiological Parameters in Children Who Had Skin Prick Test Applied

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401408
• Other study ID #: ERU-NF-KB-01
• Status: Not yet recruiting
• Start date: June 20, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: May 2024
• Source: TC Erciyes University
• Contact: Kazim Bagci
• Phone: +905336573633
• Email: kazimbagci[@]erciyes.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

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 (5 minutes before), the Introductory Characteristics Form for Children and Their Families and scales (so that the pain, fear and anxiety scores predicted by the children before the procedure will be measured) will be applied to the children and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be taken. Then, the children will be fitted with an VRH and watched an animated film (approximately 15 minutes long) 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 (5 minutes later), physiological parameters will be taken again and scales (thus measuring the pain, fear and anxiety scores felt by the children during the procedure) will be applied.

Control group application phase:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

1. Between the ages of 4-7,

2. Does not have a chronic or genetic disease,

3. No mental, visual or hearing impairment,

4. No analgesics or sedatives were administered at least one hour before the test procedure,

5. Both he and his parents are open to communication and cooperation,

6. Children who both themselves and their parents volunteer to participate in the research and give verbal and written consent will be included.

Exclusion Criteria:

1. Those who are outside the 4-7 age range,

2. Having a chronic or genetic disease,

3. Mentally, visually or hearing impaired,

4. Applying analgesics and sedatives at least one hour before the test procedure,

5. The child who cannot adapt to virtual reality glasses,

6. Both he and his parents do not cooperate,

7. 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.

Related Conditions & MeSH terms

• Allergy
• Hypersensitivity

Locations

Country	Name	City	State
Turkey	Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital	Kayseri	Melikgazi

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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/medicina5603 — View Citation

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.1398-9995.2003.00 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Children's Anxiety Meter-State (CAM-S)	The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the bulb or bottom part of the thermometer. If you are a little bit worried or nervous, the feelings might come up in the thermometer just a little bit.Put a line on the thermometer showing how much worry or nervousness you feel."When children did not understand this analogy, we used an alternate script that did not explicitly describe a thermometer. Children were asked to "Pretend that all of your worried or nervous feelings are in the very bottom down here. If you are a little bit worried or nervous, the feelings might come up just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line showing how much worry or nervousness you feel."	4 weeks