The Effect of Virtual Reality Glasses on Pain on Intravenous Cannulatıon in Children

NCT ID: NCT05273866

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2019-08-31

Brief Summary

This study was carried out to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study consisted of 70 children (35 children in the virtual reality video group and 35 children in the control group). Ethics committee approval, permissions from institutions and informed voluntary consent of the children were obtained in order to conduct the study. The data of the study were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. A p value of <0.05 was considered statistically significant in data analysis.

Detailed Description

This randomized controlled experimental study was conducted to determine the effect of virtual reality glasses on reducing pain during vascular access in children. The study was conducted among children aged 7-12 years in a tertiary hospital. Children in the experimental group (n=35) and control group (n=35); Age, gender, class of education, previous hospitalization and vascular access experience criteria were selected similar (p>0.05). Data were collected with Child Descriptive Characteristics Form, Parent Descriptive Characteristics Form, Visual Analog Scale (VAS), Revised Facial Expression Pain Scale (FPS-R), Intervention Monitoring Form, Child Behavior Observation Form, and Parent Behavior Observation Form. In the study, the children in the experimental group were shown a video with virtual reality glasses during the vascular access procedure. Before and after the study; The child and his parents were asked to evaluate the pain experienced/will experience during the procedure, the children's heart rate, O2 saturation, body temperature were measured, and the behaviors of the child and the parent during the procedure were evaluated. Data were used post-power analysis, descriptive statistics, Shapiro Wilk, Pearson chi-square, Mann Whitney U and Two-Related-Samples Tests. A p value of <0.05 was considered statistically significant in data analysis.

Conditions

Pain, Procedural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Virtual reality

Virtual reality video application

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

Virtual Reality video application reduces pain by distracting. The intervention group was watched video during the procedure, starting before the procedure.

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality

Virtual Reality video application reduces pain by distracting. The intervention group was watched video during the procedure, starting before the procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• between the ages of 7-12,
• Does not have a disease that causes chronic pain,
• Not taking any analgesic medication in the last 8 hours before the procedure,
• No mental or neurological disability,
• Having no visual or auditory problems that prevent you from applying the scales or watching videos,
• Does not have eye problems and/or does not use glasses to be able to wear VR glasses,
• The first vascular access procedure was performed during this hospitalization at the clinic,
• Vascular access opened on the first try,
• Speaking and understanding Turkish,
• Children whose parents and themselves agreed to participate in the study were included in the study.

Exclusion Criteria

• Does not understand the Turkish language
• the child is under 7 years old or 12 years older
• having vision, hearing or speech problems
• having a mental or neurological disability

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

Sponsors

Nevsehir Haci Bektas Veli University

OTHER

Sponsor Role: lead

Responsible Party

Bahriye Kaplan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bahriye Kaplan, Doctor

Role: STUDY_DIRECTOR

Nevsehir Haci Bektas Veli University

Locations

Bahriye Kaplan

Nevşehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

84902927

Identifier Type: -

Identifier Source: org_study_id