Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04950478
Status:
COMPLETED
Last Update Posted:
2021-07-06
First Post:
2021-06-29
Brief Title:
Effect of Virtual Reality on Child Pain
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
THE EFFECT OF VIRTUAL REALITY ON PAIN EXPERIENCED BY SCHOOL-AGE CHILDREN DURING VENIPUNCTURE RANDOMIZED CONTROLLED STUDY
Status:
COMPLETED
Status Verified Date:
2021-06
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 is a randomized controlled experimental study conducted to determine effect of using virtual reality headset during venipuncture on pain level heart rate and oxygen saturation values among 7-12 year-old children The data were collected from 102 children coming to vaccination room of an university hospitals pediatric outpatient clinic Before the venipuncture state anxiety scores of children in both groups were evaluated The children in experimental group wore virtual reality headset during the venipuncture The children in control group were subjected to standard venipuncture procedure Before during and after the venipuncture pulse and oxygen saturation values were measured
Detailed Description:
The research was designed as a randomized controlled experimental study The population of the study consisted of all 7-12 year-old children who came to a vaccination room of an university hospitals pediatric outpatient clinic It is stated in the literature that the sample size should be determined as minimum 41 in both experimental and control groups in the experimental studies
In the study randomization Urn method was carried out Urn method consists of two parameters α and β These parameters are matched with two different colored balls red and white One of the balls was randomly selected and if this ball was white the individual was assigned to α group if it was red then participant was assigned to β group This process was repeated for each assignment In the study white ball was determined as control group whereas red ball was determined as experimental group In the case of a child meeting the sampling criteria these balls that the researcher had previously prepared were placed in a black bag and any nurse working in the pediatrics outpatient clinic at that time was asked to draw a ball from the bag The children were assigned to experimental or control group based on color of the selected ball so that they were randomly distributed to two groups A total of 106 children including 54 children in the experimental group and 52 children in the control group were included in the sample group by taking possible case losses into account Since 2 children in the experimental group did not want to wear the virtual reality headset during the procedure they were excluded from the sample 2 children in the control group were excluded from the sample because venipuncture procedure did not take place at once Thus the sample group consisted of 102 children in total including 52 children in the experimental group and 50 children in the control group The study followed the CONSORT guideline for reporting randomized controlled trials The data collection questionnaries included a Child and Parent Information Form State-Trait Anxiety Inventory for Children and Faces Pain Scale-Revised FPS-R
In the study randomization Urn method was carried out Urn method consists of two parameters α and β These parameters are matched with two different colored balls red and white One of the balls was randomly selected and if this ball was white the individual was assigned to α group if it was red then participant was assigned to β group This process was repeated for each assignment In the study white ball was determined as control group whereas red ball was determined as experimental group In the case of a child meeting the sampling criteria these balls that the researcher had previously prepared were placed in a black bag and any nurse working in the pediatrics outpatient clinic at that time was asked to draw a ball from the bag The children were assigned to experimental or control group based on color of the selected ball so that they were randomly distributed to two groups A total of 106 children including 54 children in the experimental group and 52 children in the control group were included in the sample group by taking possible case losses into account Since 2 children in the experimental group did not want to wear the virtual reality headset during the procedure they were excluded from the sample 2 children in the control group were excluded from the sample because venipuncture procedure did not take place at once Thus the sample group consisted of 102 children in total including 52 children in the experimental group and 50 children in the control group The study followed the CONSORT guideline for reporting randomized controlled trials The data collection questionnaries included a Child and Parent Information Form State-Trait Anxiety Inventory for Children and Faces Pain Scale-Revised FPS-R
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