Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421779
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2024-05-15
Brief Title:
The Effect of Virtual Reality VR on Skin Prick Test Related Pain and Fear in Children
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
A Game-Like Skin Testing Experience The Effect of Virtual Reality VR on Skin Prick Test Related Pain and Fear in Children Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to show the effect of VR on skin prick test-related pain and fear in children The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR
Detailed Description:
Pain and fear during interventional procedures in pediatric patients are some of the most difficult problems in hospitals While bad experiences in childhood can lead to increased sensitivity to pain sleep problems social learning difficulties phobias pre-treatment anxiety disorders and treatment resistance increases the risk of anxiety and depression in adulthood
Skin prick test is the gold standard diagnostic method most frequently used in Pediatric Allergy clinics for the detection of allergens with high sensitivity specificity and reliability The numerous pricking procedures performed during the skin test may turn into a painful and frightening experience for children
Virtual reality VR is often accomplished using a special headset or glasses and can create for children a virtual world separate from their current physical environment effectively distracting them from the possible pain and fear experience
There is no study in the literature investigating the effect of VR on skin prick test-related pain and fear in children This study aims to show the effect of VR on skin prick test-related pain and fear in children The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR
The hypotheses of this study were to
H1 The virtual reality VR group will experience less pain due to the skin prick test than the control group
H2 The virtual reality VR group will experience less fear due to the skin prick test than the control group
Study Design
This study is a parallel group randomized controlled trial planned to be conducted in the skin testing unit of a tertiary reference center of a pediatric allergy outpatient clinic between March and June 2024 The CONSORT guideline will be followed in the study Fifty children between the ages of 4 and 10 years who decided to undergo skin prick testing will be randomized into two groups using VR VR group n 25 and not using VR Control group n 25 by block randomization method The reason for choosing this age group is that this age group is the common validation age range of the Wong-Baker FACES Pain Rating Scale WB-FACES and Child Fear Scale CFS which the investigators will use in the evaluation of pain and fear in the Turkish children At the same time children in this age group are curious about technology and open to collaboration
Sample Size and Randomization
The number of patients was determined by taking the data obtained from the reference study titled The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children Distraction Cards Virtual Reality and Buzzy Randomized Controlled Trial Power analysis was performed based on self-report data of the WB-FACES Pain Rating scale in the study According to the calculation by GPower 3197 the effect size was determined as 092 the alpha margin of error was 005 the statistical power was 80 and it was determined that at least 19 participants in each group were required to conduct the study The analysis showed that a total sample size of 38 participants would be sufficient to detect significant differences In light of the potential losses of 10 that may occur during the study the investigators planned to include at least 21 participants in both groups to obtain a total of 42 participants
In the literature the studies show that gender and age affect pain and fear associated with invasive procedures in children Therefore gender girls and boys and age group 4-6 years preschool and 7-10 years school age variables were used for block randomization Blocks were repeated 5 times in each group 25 participants were assigned to each of the VR and Control groups A blocked randomization list was developed using an online randomization tool The investigators were not blinded to group allocation because they performed the randomization themselves
Ethics
The study was approved by the local research ethics committee of our institution 202466 All participants will take part voluntarily and personal written informed consent will be obtained from the parents of all participants and verbal consent will be obtained from the participants before participation
Data Collection Tools
Data will be collected with a case report form created using WB-FACES and CFS Both scales are suitable for personal parent and researcher evaluation In our study childrens personal parent and researcher reporting data will be evaluated for both scales Investigator reporting data will be evaluated by a specialist nurse trained on the scales
Wong-Baker FACES Pain Rating Scale WB-FACES
The Wong-Baker FACES Pain Rating Scale WB-FACES was developed in 1981 and revised in 1983 WB-FACES is a reliable scale that has been validated for the Turkish population The scale is used to diagnose pain in children ages 3-18 years It consists of six facial expressions each representing increasing degree of pain scored from 0 to 10 from left to right 0 very happy faceno pain 10 a crying faceworst pain imaginable High scores indicate low pain tolerance The child is asked to rate hisher pain by asking Can you show me the face that shows how you feel right now
Childrens Fear Scale CFS
The Child Fear Scale CFS was developed in 2011 It was adapted into Turkish in 2018 by studying it with children aged 4-10 years It consists of five facial expressions representing a range from neutral0 to extreme fear4
Virtual Reality VR
Virtual reality VR allows the user to visit a three-dimensional world isolating them from real life VR is an advanced technology that offers a 360-degree visual and audio simulation that surrounds the user and allows them to look in all directions In this study VR intervention will be performed using a smartphone Samsung Galaxy S23 Ultra Qualcomm Snapdragon 8 Gen 2 processor 12 GB RAM Android 14 version One UI 60 version Dynamic AMOLED 1440x3088 QHD Pixel Screen Stereo Dual Speakers VR glasses Schulzz VRG Pro and a VR underwater experience video 2160p resolution video suitable for VR format that will attract the attention of age groups
Procedure
Each child will be admitted to the skin testing unit with hisher parents The skin testing unit has the same environmental conditions seat temperature light noise etc Participants will be randomly selected into groups The researcher will inform the participants and parents about the skin prick test and scales WB-FACES and CFS Before the procedure all participants will be asked verbally about their baseline fear status due to the skin prick test
Participants in the VR group will put on VR glasses for approximately two minutes before the skin prick test and watch a VR underwater experience video throughout the procedure Participants in the control group will undergo a routine skin prick test procedure The VR intervention and skin prick testing will terminate at the same time The researcher will use a case report form to collect data for participants and their parents Immediately after the procedure participants will describe their pain levels with WB-FACES and their fear levels with CFS Meanwhile a volunteer parent and a specialist nurse will observe the childrens behavior and perform the WB-FACES and CFS evaluations separately The data collection process will be planned to be completed in approximately ten minutes
Skin prick test
Skin prick tests will be performed over the same period by a volunteer nurse with at least 5 years of experience All participants will undergo the same aeroallergen skin test panel Skin prick tests will be performed using a prick test applicator MedBlue One Türkiye on the flexural aspect of the forearm by standard guidelines using standardized glycerinated extracts 1 weightvolume from LOFARMA Milan Italy
Statistical analysis
SPSS version 230 statistical software IBM SPSS Inc Chicago IL USA will be used for statistical analysis Categorical variables will be presented as numbers and continuous variables will be presented as meanSD and median values interquartile range-IQR Univariate analyses including categorical data will be performed using the χ2 test If data exhibit normality according to the Shapiro-Wilk normality test parametric values will be analyzed using the Students t-test and non-parametric variables will be analyzed using the Mann-Whitney U test P005 value was considered statistically significant
Skin prick test is the gold standard diagnostic method most frequently used in Pediatric Allergy clinics for the detection of allergens with high sensitivity specificity and reliability The numerous pricking procedures performed during the skin test may turn into a painful and frightening experience for children
Virtual reality VR is often accomplished using a special headset or glasses and can create for children a virtual world separate from their current physical environment effectively distracting them from the possible pain and fear experience
There is no study in the literature investigating the effect of VR on skin prick test-related pain and fear in children This study aims to show the effect of VR on skin prick test-related pain and fear in children The investigators will compare the effect of VR on skin prick test-induced pain and fear in children applying to the Pediatric Allergy outpatient clinic with controls who underwent skin prick test without the use of VR
The hypotheses of this study were to
H1 The virtual reality VR group will experience less pain due to the skin prick test than the control group
H2 The virtual reality VR group will experience less fear due to the skin prick test than the control group
Study Design
This study is a parallel group randomized controlled trial planned to be conducted in the skin testing unit of a tertiary reference center of a pediatric allergy outpatient clinic between March and June 2024 The CONSORT guideline will be followed in the study Fifty children between the ages of 4 and 10 years who decided to undergo skin prick testing will be randomized into two groups using VR VR group n 25 and not using VR Control group n 25 by block randomization method The reason for choosing this age group is that this age group is the common validation age range of the Wong-Baker FACES Pain Rating Scale WB-FACES and Child Fear Scale CFS which the investigators will use in the evaluation of pain and fear in the Turkish children At the same time children in this age group are curious about technology and open to collaboration
Sample Size and Randomization
The number of patients was determined by taking the data obtained from the reference study titled The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children Distraction Cards Virtual Reality and Buzzy Randomized Controlled Trial Power analysis was performed based on self-report data of the WB-FACES Pain Rating scale in the study According to the calculation by GPower 3197 the effect size was determined as 092 the alpha margin of error was 005 the statistical power was 80 and it was determined that at least 19 participants in each group were required to conduct the study The analysis showed that a total sample size of 38 participants would be sufficient to detect significant differences In light of the potential losses of 10 that may occur during the study the investigators planned to include at least 21 participants in both groups to obtain a total of 42 participants
In the literature the studies show that gender and age affect pain and fear associated with invasive procedures in children Therefore gender girls and boys and age group 4-6 years preschool and 7-10 years school age variables were used for block randomization Blocks were repeated 5 times in each group 25 participants were assigned to each of the VR and Control groups A blocked randomization list was developed using an online randomization tool The investigators were not blinded to group allocation because they performed the randomization themselves
Ethics
The study was approved by the local research ethics committee of our institution 202466 All participants will take part voluntarily and personal written informed consent will be obtained from the parents of all participants and verbal consent will be obtained from the participants before participation
Data Collection Tools
Data will be collected with a case report form created using WB-FACES and CFS Both scales are suitable for personal parent and researcher evaluation In our study childrens personal parent and researcher reporting data will be evaluated for both scales Investigator reporting data will be evaluated by a specialist nurse trained on the scales
Wong-Baker FACES Pain Rating Scale WB-FACES
The Wong-Baker FACES Pain Rating Scale WB-FACES was developed in 1981 and revised in 1983 WB-FACES is a reliable scale that has been validated for the Turkish population The scale is used to diagnose pain in children ages 3-18 years It consists of six facial expressions each representing increasing degree of pain scored from 0 to 10 from left to right 0 very happy faceno pain 10 a crying faceworst pain imaginable High scores indicate low pain tolerance The child is asked to rate hisher pain by asking Can you show me the face that shows how you feel right now
Childrens Fear Scale CFS
The Child Fear Scale CFS was developed in 2011 It was adapted into Turkish in 2018 by studying it with children aged 4-10 years It consists of five facial expressions representing a range from neutral0 to extreme fear4
Virtual Reality VR
Virtual reality VR allows the user to visit a three-dimensional world isolating them from real life VR is an advanced technology that offers a 360-degree visual and audio simulation that surrounds the user and allows them to look in all directions In this study VR intervention will be performed using a smartphone Samsung Galaxy S23 Ultra Qualcomm Snapdragon 8 Gen 2 processor 12 GB RAM Android 14 version One UI 60 version Dynamic AMOLED 1440x3088 QHD Pixel Screen Stereo Dual Speakers VR glasses Schulzz VRG Pro and a VR underwater experience video 2160p resolution video suitable for VR format that will attract the attention of age groups
Procedure
Each child will be admitted to the skin testing unit with hisher parents The skin testing unit has the same environmental conditions seat temperature light noise etc Participants will be randomly selected into groups The researcher will inform the participants and parents about the skin prick test and scales WB-FACES and CFS Before the procedure all participants will be asked verbally about their baseline fear status due to the skin prick test
Participants in the VR group will put on VR glasses for approximately two minutes before the skin prick test and watch a VR underwater experience video throughout the procedure Participants in the control group will undergo a routine skin prick test procedure The VR intervention and skin prick testing will terminate at the same time The researcher will use a case report form to collect data for participants and their parents Immediately after the procedure participants will describe their pain levels with WB-FACES and their fear levels with CFS Meanwhile a volunteer parent and a specialist nurse will observe the childrens behavior and perform the WB-FACES and CFS evaluations separately The data collection process will be planned to be completed in approximately ten minutes
Skin prick test
Skin prick tests will be performed over the same period by a volunteer nurse with at least 5 years of experience All participants will undergo the same aeroallergen skin test panel Skin prick tests will be performed using a prick test applicator MedBlue One Türkiye on the flexural aspect of the forearm by standard guidelines using standardized glycerinated extracts 1 weightvolume from LOFARMA Milan Italy
Statistical analysis
SPSS version 230 statistical software IBM SPSS Inc Chicago IL USA will be used for statistical analysis Categorical variables will be presented as numbers and continuous variables will be presented as meanSD and median values interquartile range-IQR Univariate analyses including categorical data will be performed using the χ2 test If data exhibit normality according to the Shapiro-Wilk normality test parametric values will be analyzed using the Students t-test and non-parametric variables will be analyzed using the Mann-Whitney U test P005 value was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None