An observational study in Allergy, sponsored by TC Erciyes University. Not yet recruiting at 1 site in Turkey. Open to participants aged 4 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by TC Erciyes University · Observational
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
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 32 is below the median of 115 across 479 observational studies indexed under Hypersensitivity.
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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.
Exclusion Criteria:
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 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.
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.
Time frame: 4 weeks
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."
Time frame: 4 weeks
Plan to share: No
This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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TC Erciyes University