Clinical trial NCT05585840: The Effect of Biofeedback-Based Virtual Reality Game on Children
Official title: The Effect of Biofeedback-Based Virtual Reality Game on Pain, Fear and Anxiety Levels During Insertion of Port Needle in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: port catheter
pediatric oncology
pain
anxiety
fear
biofeedback
virtual reality
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

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'.

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.

Primary outcomes:
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: Evaluation will be done approximately 5 minutes after port catheter needle placement.
measure: The Child Fear Scale (CFS)
timeFrame: It will be evaluated 5-minute before the insertion of port needle.
measure: The Child Fear Scale (CFS)
timeFrame: It will be evaluated 5-minute after the insertion of port needle.
measure: The Children's Anxiety Meter (CAM)
timeFrame: It will be evaluated 5-minute before the insertion of port needle.
measure: The Children's Anxiety Meter (CAM)
timeFrame: It will be evaluated 5-minute after the insertion of port needle.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Eyşan Hanzade Umaç
role: STUDY_DIRECTOR
References: