Effect of Virtual Reality on Child Pain

Pain Clinical Trial

Official title:

THE EFFECT OF VIRTUAL REALITY ON PAIN EXPERIENCED BY SCHOOL-AGE CHILDREN DURING VENIPUNCTURE: RANDOMIZED CONTROLLED STUDY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04950478
• Other study ID #: Virtual Reality use on Pain
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: June 2021
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 hospital's 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.

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 hospital's 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 30, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged 7-12 who agreed to participate in the study by giving written and verbal consent,

• Parents who agreed to participate in the study verbally and in written by signing informed consent form,

• Body temperature within normal values for children (36.5- 37.2 oC),

• Children who were healthy and for whom the doctor requested a blood test for general control.

• Children who were healthy in sensory and neurologic aspects.

Exclusion Criteria:

• Having any chronic disease or any disease causing pain in children,

• Having hearing, mental or neurological disability in children,

• Having history of syncope during previous venipuncture procedures for the children,

• Having visual impairment in children,

• Unsuccessful venipuncture procedure in the first attempt.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Virtual Reality
5 minutes before the procedure, they were recorded on 'Child and Parent Information Form', State-Trait Anxiety Inventory for Children and FPS-R. Their heart rate and oxygen saturation values were read and recorded. Children wore the virtual reality headset and game was started one minute before the venipuncture. As soon as the injector inserted, the researcher turned on a stopwatch and read and recorded heart rate and oxygen saturation values. When the injector was removed, the researcher stopped the stopwatch and recorded the duration of the procedure.When the injector was removed, the stopwatch was stopped and heart rate and oxygen saturation were recorded. The children took off the virtual reality headset and were asked to evaluate their pain level through FPS-R and their responses were recorded.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa	Istanbul University - Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	The children were informed about the Faces Pain Scale-Revised (FPS-R) and they were asked to mark the children's pain levels on the scale before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.	Between 5-10 minutes
Secondary	Heart Rate	Heart rate values were read and recorded form the pulse oximeter before venipuncture, as soon as the injector inserted and after the injector removed.	Between 5-10 minutes
Secondary	Oxygen Saturation	Oxygen saturation values were read and recorded form the pulse oximeter before venipuncture, as soon as the injector inserted and after the injector removed.	Between 5-10 minutes