The Effect of Biofeedback-Based Virtual Reality Game on Children

NCT05585840 | Completed

• 1 other identifier: Eysan Hanzade Umac
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Keywords

port catheter; pediatric oncology; pain; anxiety; fear; biofeedback; virtual reality

Outcome Measures

Primary Outcomes (5)

• Wong-Baker Faces Pain Rating Scale

  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)

  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)

  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)

  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)

  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.

Study Arms (2)

Biofeedback-based virtual reality group/Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Biofeedback-based virtual reality game DEVICE

The application will be a biofeedback-based virtual reality game developed by the researchers in collaboration with engineering in line with the literature review.

Biofeedback-based virtual reality group/Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Eyşan Hanzade Umaç

  Koç University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and Research Assistant

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 19, 2022
• Study Start: July 15, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)