Clinical trial · Interventional
The Effect of Biofeedback-Based Virtual Reality Game on Children
The Effect of Biofeedback-Based Virtual Reality Game on Pain, Fear and Anxiety Levels During Insertion of Port Needle in Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biofeedback-based virtual reality game | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Biofeedback-based virtual reality group/Intervention
- 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.
- interventionNames
- Device: Biofeedback-based virtual reality game
- type
- NO_INTERVENTION
- label
- Control 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.
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 12 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available