Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test
NCT ID: NCT06401408
Last Updated: 2024-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
32 participants
OBSERVATIONAL
2024-06-20
2025-04-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
4 Years
7 Years
ALL
Yes
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Kazım Bagci
Clinical nurse specialist
Principal Investigators
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Fulya Tahan, Prof. Dr.
Role: STUDY_CHAIR
responsible for medical procedures
Locations
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Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital
Kayseri, Melikgazi, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Kazım Bağcı
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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ERU-NF-KB-01
Identifier Type: -
Identifier Source: org_study_id
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