Clinical trial NCT06605339: Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion
Official title: Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Cancer
Keywords: pediatric
cancer
virtual reality
pain
fear
emotional behavior
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Afyonkarahisar Health Science University
First posted: 2024-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In pediatric hematology-oncology patients, the need for a central venous catheter may arise in some cases to provide treatment. Totally implanted vascular access devices are known as "ports," and port catheters are commonly used due to their lower risk of infection. To maintain the port system and prevent infection, the port needle should be replaced every 5-7 days. During the course of treatment, pediatric hematology-oncology patients undergo frequently repeated procedures associated with high levels of pain and distress. Pain and distress resulting from repeated procedures are often uncomfortable symptoms for pediatric patients and their families. There are pharmacological and non-pharmacological methods to reduce pain and anxiety during port needle procedures in pediatric hematology-oncology patients. One pharmacological method, distraction, increases pain tolerance by focusing attention away from the painful stimulus. This technique is used as a powerful tool for pain and anxiety management in pediatric pain. Virtual reality glasses, used as a distraction method, provide access to an interactive, three-dimensional, computer-simulated environment through a head-mounted device that blocks out real-world views. It is stated that distraction with virtual reality is a beneficial non-pharmacological method for children during hospital-based needle applications for pediatric patients. This study evaluated the effect of virtual reality on pain, fear, and emotional appearance related to needle procedures in pediatric hematology-oncology patients during port needle changes.

Detailed description: The study was conducted at the Pediatric Hematology and Oncology Clinic of Afyonkarahisar Health Sciences University Health Practice and Research Center.

Research Hypotheses:

H1: There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes.

H2: There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes.

Randomization:

A stratified randomization scheme was used for distributing the sample into groups. Stratification was done based on gender (female, male), age group (4-7, 8-12), and port duration (\<1 month, \>1 month).

Patients requiring port needle changes were assigned to groups according to the randomization scheme. No additional intervention was made for patients in the control group; they were observed during the procedure after obtaining consent. Patients in the study group were introduced to the virtual headset and informed that they could watch a video using the virtual reality headset during the procedure. The "Epic Roller Coasters" video game was initiated. If the child wanted to remove the glasses during the procedure, they were excluded from the study. Before the procedure, the fear score was determined by asking both the patient and the parent using the Children's Fear Scale. After the procedure, the pain levels were evaluated independently by the child, the mother, the attending nurse, and the researcher. Following the intervention, the child's emotional appearance was assessed by the nurse.

Eligibility criteria: Inclusion Criteria:

* The child having a port catheter in place.
* The child agreeing to voluntarily participate in the study.
* The parent agreeing to voluntarily participate in the study.
* Obtaining consent forms from both the child and the parent.

Exclusion Criteria:

The child had a physical or psychological deficits that would prevent the child from wearing the headset needed to watch virtual reality

Primary outcomes:
measure: Pain assesed by Wong-Baker FACES
timeFrame: after the port needle insertion
measure: Fear assesed by Child Fear Scale
timeFrame: after the port needle insertion
measure: emotional apperance assesed by Emotional Appearance Scale for Children
timeFrame: after the port needle insertion
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gülçin Özalp Gerçeker
Study officials:
affiliation: Dokuz Eylul University
name: Gulcin Ozalp Gerceker, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: