The Effect of Biofeedback-Based Virtual Reality Game on Children

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585840
• Other study ID #: Eysan Hanzade Umac
• Status: Completed
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Koç University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.

Locations

Country	Name	City	State
Turkey	Koc University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.