Clinical trial NCT06401408: Effect of Virtual Reality Headsets on Fear Anxiety and Physiological Parameter in Skin Prick Test
Official title: Effect of Virtual Reality Headsets on Pain, Anxiety, Fear and Physiological Parameters in Children Who Had Skin Prick Test Applied
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Allergy
Keywords: allergy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Fear Scale (CFS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Children's Anxiety Meter-State (CAM-S)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital
state: Melikgazi
Study officials:
affiliation: responsible for medical procedures
name: Fulya Tahan, Prof. Dr.
role: STUDY_CHAIR
References:
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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.1398-9995.2003.00323.x.
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.
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