The Effect of Biofeedback-Based Virtual Reality Game on Children

NCT ID: NCT05585840

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2023-12-31

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.

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'.

Conditions

Pediatric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Biofeedback-based virtual reality game

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Eysan Hanzade Umac

Teaching and Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyşan Hanzade Umaç

Role: STUDY_DIRECTOR

Koç University

Locations

Koc University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Eysan Hanzade Umac

Identifier Type: -

Identifier Source: org_study_id