Effect of Virtual Reality on Child Pain

NCT ID: NCT04950478

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-05-30

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 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.

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 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).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual Reality

The children wore the virtual reality headset and game was started one minute before the venipuncture. The children took off the virtual reality headset after the venipuncture ended.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: OTHER

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.

Control Group

No intervention was performed to reduce pain in the control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Eda Orhan

PhD RN, Educator Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul University-Cerrahpaşa Florence Nightingale Faculty of Nursing

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Orhan E, Gozen D. The Effect of Virtual Reality on Pain Experienced by School-Age Children During Venipuncture: A Randomized Controlled Study. Games Health J. 2023 Aug;12(4):330-339. doi: 10.1089/g4h.2022.0232.

Reference Type: DERIVED

PMID: 37466456 (View on PubMed)

Other Identifiers

Virtual Reality use on Pain

Identifier Type: -

Identifier Source: org_study_id