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Completed

NCT Number: NCT05273866

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahriye Kaplan

Nevşehir, 50100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

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

Primary outcomes

  1. Visual Analog Scale (VAS), Change:

    Time frame: 2 minutes before and 2 minutes after Intravenous Cannulatıon

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

    Time frame: 3 minutes before and 3 minutes after Intravenous Cannulatıon

    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.

Secondary outcomes

  1. Physiological parameters

    Time frame: 2 minutes before and 2 minutes after Intravenous Cannulatıon

    Heart Rate, Change

  2. Physiological parameters

    Time frame: 3 minutes before and 3 minutes after Intravenous Cannulatıon

    Oxygen saturation, Change

Sponsors and collaborators

Lead sponsor

Nevsehir Haci Bektas Veli University

Other

Registry information

Official study title

A Technological Intervention in Pain Control on Intravenous Cannulatıon in Children Virtual Reality Glasses: A Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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