The Effect of Biofeedback-Based Virtual Reality Game on Children

March 4, 2024 updated by: Eysan Hanzade Umac, Koç University

The Effect of Biofeedback-Based Virtual Reality Game on Pain, Fear and Anxiety Levels During Insertion of Port Needle in Children

The needles of port catheters, which are often used in childhood cancer treatment, must be changed every 5-7 days, which causes pain, anxiety, and fear in children every 5-7 days In recent years, the usage of virtual reality has grown to distract children during port catheter needle insertion. But it's not always easy for children to switch their attention to something else. A good child distractor must be sensory-stimulating, developmentally appropriate, and highly interactive.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Today, virtual reality applications have advanced, and software that provides biofeedback with breathing has improved engagement with the user. Our aim in this study is to examine the effect of biofeedback-based virtual reality games on pair, fear and anxiety levels during insertion of port needle insertion in children.

The randomized control trial design will be used, and The CONSORT list will be used to guide the research. This study will be conducted at the 62 pediatric oncology patients (31 experiment/ 31 control) aged 6-12 years. This study will be carry out in a university hospital in Istanbul, Turkey between January 2023, and June 2023. The research data will collect from the children's self-reports and parents through a survey form and scales. Children's pain will evaluate by the children and parent with Wong-Baker Faces Pain Rating Scale, child fear will evaluate by the children and parent with 'Child Fear Inventory', and child anxiety will evaluate by the children and parent with 'Child Anxiety Statement Scale'.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Koç University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Between the ages of 6-12,
  • Requires venous access
  • Diagnosed with childhood cancer,
  • Volunteers with at least one venous access experience.

Exclusion Criteria:

  • With neurodevelopmental delay,
  • Difficulty in verbal communication
  • Auditory or visual impairment
  • Those who have used analgesics in the last 24 hours and have a history of needle phobia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback-based virtual reality group/Intervention
When approaching the moment of the procedure (2 minutes before), children will be asked to put on the virtual reality glasses, saturation probe and respiratory sensor in addition to routine care. At this stage, the child will be assisted by the researcher. The launch of the mobile application on the researcher's phone will be provided just before the port needle placement (1 minute before). In this process, the child will provide biofeedback to the game with regular and deep breathing behavior. The game will end when the port pin placement is complete.
Device: Biofeedback-based virtual reality game
The application will be a biofeedback-based virtual reality game developed by the researchers in collaboration with engineering in line with the literature review.
No Intervention: Control group
In the pediatric oncology unit where the study will conduct, there is no standard pharmacological and non-pharmacological application use to reduce pain, anxiety, and fear during intervention. Family presence and positive encouragement are used in routine care. For children in this group, port catheter needle insertion will be performed in accordance with their clinical routines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Faces Pain Rating Scale
Time Frame: Evaluation will be done approximately 5 minutes after port catheter needle placement.
Wong-Baker Faces Pain Rating Scale. It is used in the assessment of pain in children. The scale consists of six facial expressions. Facial expressions range from 0 points of "no pain-very happy" to 10 points of "unbearable pain-crying". It is commonly used in children aged 3-18. It has good validity and reliability for the measurement of pain severity and is psychometrically suitable and widely used in clinical practice.
Evaluation will be done approximately 5 minutes after port catheter needle placement.
The Child Fear Scale (CFS)
Time Frame: It will be evaluated 5-minute before the insertion of port needle.
The Child Fear Scale (CFS). It measures procedure-related fear in children. It consists of five sex-neutral faces; 0 (no fear) - 4 (extreme fear). It is based on the Faces Anxiety Scale. The FAS changed developmentally to the CFS. It can be used by the parents during the procedure for 5-10 years old children. Assessment of construct validity revealed high concurrent convergent validity with another self-report measure of fear and moderate discriminant validity with coping and distress behavior.
It will be evaluated 5-minute before the insertion of port needle.
The Child Fear Scale (CFS)
Time Frame: It will be evaluated 5-minute after the insertion of port needle.
The Child Fear Scale (CFS). It measures procedure-related fear in children. It consists of five sex-neutral faces; 0 (no fear) - 4 (extreme fear). It is based on the Faces Anxiety Scale. The FAS changed developmentally to the CFS. It can be used by the parents during the procedure for 5-10 years old children. Assessment of construct validity revealed high concurrent convergent validity with another self-report measure of fear and moderate discriminant validity with coping and distress behavior.
It will be evaluated 5-minute after the insertion of port needle.
The Children's Anxiety Meter (CAM)
Time Frame: It will be evaluated 5-minute before the insertion of port needle.
The Children's Anxiety Meter (CAM). It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
It will be evaluated 5-minute before the insertion of port needle.
The Children's Anxiety Meter (CAM)
Time Frame: It will be evaluated 5-minute after the insertion of port needle.
The Children's Anxiety Meter (CAM). It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
It will be evaluated 5-minute after the insertion of port needle.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Study Director: Eyşan Hanzade Umaç, Koç University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Eysan Hanzade Umac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Cancer

Clinical Trials on Biofeedback-based virtual reality game

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe