CClinicalTrials.gg
CompletedNCT05273866Updated Mar 10, 2022

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

An interventional study of Virtual reality in Pain, Procedural, sponsored by Nevsehir Haci Bektas Veli University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Nevsehir Haci Bektas Veli University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Apr 2019, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain, Procedural

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Keywords

  • distraction
  • intravenous cannulation
  • pain
  • school-aged children
  • virtual reality glasses
03

In context

Pain, Procedural

237 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's enrollment of 70 is below the median of 83 across 223 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

Nevsehir Haci Bektas Veli University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Virtual reality

    Virtual reality video application

    Other: Virtual reality

  • No intervention
    control group

    control group

Interventions

  • OtherVirtual reality

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

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Physiological parameters

    Heart Rate, Change

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

  2. Physiological parameters

    Oxygen saturation, Change

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

07

Study locations

1 site
  • Bahriye Kaplan
    Nevşehir, 50100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05273866
Lead sponsor
Nevsehir Haci Bektas Veli University
Responsible party
Bahriye Kaplan (Principal Investigator, Nevsehir Haci Bektas Veli University) — Principal investigator
First posted
Mar 10, 2022
Start date
Apr 29, 2019
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019
Last update
Mar 10, 2022

Study contacts

Bahriye Kaplan, Doctor
study director · Nevsehir Haci Bektas Veli University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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