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

NCT05273866 | Completed

• 1 other identifier: 84902927
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Procedural

Keywords

distraction; intravenous cannulation; pain; school-aged children; virtual reality glasses

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS), Change:

  The severity of the pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.

  2 minutes before and 2 minutes after Intravenous Cannulatıon

• Faces Pain Scale-Revised (FPS-R), Change:

  In the scale consisting of facial expressions, each facial expression has a number equivalent. The severity of pain marked by the child on the scale ranges from 0 to 10. If the severity increases after the procedure, it indicates that the pain increases, and if it decreases, it indicates that the pain decreases.

  3 minutes before and 3 minutes after Intravenous Cannulatıon

Secondary Outcomes (2)

• Physiological parameters

  2 minutes before and 2 minutes after Intravenous Cannulatıon

• Physiological parameters

  3 minutes before and 3 minutes after Intravenous Cannulatıon

Study Arms (2)

Virtual reality

EXPERIMENTAL

Virtual reality video application

Other: Virtual reality

control group

NO INTERVENTION

control group

Interventions

Virtual reality OTHER

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

Virtual reality

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nevsehir Haci Bektas Veli University: lead

Study Sites (1)

Bahriye Kaplan

Nevşehir, 50100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bahriye Kaplan, Doctor

  Nevsehir Haci Bektas Veli University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 10, 2022
• Study Start: April 29, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)