The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion

The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion on The Child's Emotional Responses

The purpose of this clinical trial is to evaluate the effect of the virtual reality glasses device on the child's emotional responses during invasive interventions in child health services.

The main question it aims to answer are:

- Is there a difference between the emotional responses of children who watched cartoons with virtual reality glasses (experimental group) and the children in the control group during the intravenous catheter insertion process? First, the descriptive data form for the children was filled out for the control and study groups. Then, to distract the children during the application of the intravenous catheter, they watched cartoon videos of their choice for the 7-12 age group through virtual reality glasses by using a free internet application throughout the procedure. The procedure started with tying the tourniquet and continued until the intravenous catheter insertion was completed. During this period, the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale. No intervention was applied to the control group. throughout the process the child's emotional responses were evaluated with the Children's Emotional Manifestation Scale.

No intervention was applied to the control group.

Study Overview

• Status: Completed
• Conditions: Anxiety and Fear
• Intervention / Treatment: Device: virtual reality glasses

Detailed Description

This study was conducted to determine the effect of virtual reality glasses used during intravenous catheter insertion on the child's emotional responses. The sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale. A statistically significant difference was found between the Children's Emotional Manifestation Scale scores of the children in the study and control groups. The scores of the children in the study group were statistically significantly lower than the scores of the children in the control group.During the intravenous catheter insertion process, children who watched cartoons on virtual reality glasses showed less negative emotional behavior than those who did not.The use of virtual reality glasses is a developing technology in child health services, and it is recommended to encourage their use in these services.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20160
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children who

  • were aged 7-12,
  • had parental permission,
  • gave verbal consent,
  • and whose parents could speak Turkish,
  • were conscious,
  • and did not have orthopedic, neurological, or sight-related problems that prevented wearing virtual reality glasses were included in the study.

Exclusion Criteria:

• Children who

  • had a chronic disease that required frequent vascular access,
  • had visual and hearing impairments,
  • had a mental and neurological disability,
  • had previously participated in a similar study,
  • had a febrile illness at the time of application,
  • had a history of fainting during vascular access procedures, or
  • had used medication in the last 24 hours before the application, which might have an analgesic effect, were not included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality glasses; The sample of the research, which was carried out as a randomized controlled experimental study, consisted of 102 children, including 51 in the control group and 51 in the study group, who were aged between 7 and 12 and were on treatment in the emergency department. Research data were collected using a Descriptive Data Form for Children and the Children's Emotional Manifestation Scale. During the data collection phase, first, the Descriptive Data Form for Children was filled out for the control and study groups. No intervention was applied to the control group. After the tourniquet was tied in the study group, the children started watching a video of their choice through virtual reality glasses. When the process was completed, the video was stopped. During this period, the child was evaluated using the Children's Emotional Manifestation Scale.	Device: virtual reality glasses; The population of the study consisted of children who were aged between 7- 12 and were on treatment using an intravenous catheter in the pediatric emergency unit of a state hospital in Turkey.Participants were divided into two groups, namely experimental and control groups, by using simple randomization software. The design and implementation of the study were based on the principles in the CONSORT list (Consolidated Standards of Reporting Studies). Descriptive data form for children,this form was prepared to collect information about the children included in the sample. It consists of seven questions on children's sociodemographic characteristics and previous intravenous catheter insertion experience.The Children's Emotional Manifestation Scale (CEMS), this scale was developed by Li & Lopez (2005) to measure children's emotional responses during stressful medical procedures. The VR glasses we used in our study were connected to a mobile phone.
No Intervention: standard care; Intervention during intravenous catheter insertion to the child

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Children's Emotional Manifestation Scale (CEMS)	The scale, which allows direct behavioral observation, consists of five different behavioral categories, namely facial expression, vocalization, activity, interaction, and level of cooperation. Each category includes five different observable behaviors rated by level and intensity. The scale is scored by reviewing descriptions of the behavior in each category and selecting the value that most represents the observed behavior. Each category is scored from 1 to 5. The scores obtained for each category are summed and a total score between 5- 25 is obtained. High scale scores indicate the exhibition of more negative emotional behaviors.	7 months

Collaborators and Investigators

• Sponsor: Türkan Şen

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): April 15, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Invasive procedures, Pediatrics, Emotion, Fear, Anxiety
• Other Study ID Numbers: PamukkaleU-SBF-TŞ-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No