The Effect of Virtual Reality Glasses Used During Intravenous Catheter Insertion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety and Fear Anxiety Disorders Mental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Virtual Reality Glasses

Device

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.

Primary outcomes

The Children's Emotional Manifestation Scale (CEMS)

Time frame: 7 months

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.

Sponsors and collaborators

Lead sponsor

Türkan Şen

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jan 3, 2024
Registry last updated: Jan 3, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed