The Effect of Biofeedback-Based Virtual Reality Game on Children

Koç University

Status: Completed

Conditions: Pediatric Cancer

Treatments: Device: Biofeedback-based virtual reality game

Study type: Interventional

Funder types: Other

Identifiers

NCT05585840

Eysan Hanzade Umac

Details and patient eligibility

About

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.

Full 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'.

Enrollment: 62 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

62 participants in 2 patient groups

Biofeedback-based virtual reality group/Intervention

Experimental group

Description:

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.

Treatment:

Device: Biofeedback-based virtual reality game

Control group

No Intervention group

Description:

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.