Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion

Trial Title: Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion

NCT ID: NCT06605339

Condition: Pediatric Cancer

Conditions: Keywords:
pediatric
cancer
virtual reality
pain
fear
emotional behavior

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Investigator)

Intervention:

Intervention type: Behavioral
Intervention name: Virtual Reality
Description: Virtual Reality Distraction
Arm group label: Virtual reality

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.

Criteria for 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

Gender: All

Minimum age: 4 Years

Maximum age: 12 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gülçin Özalp Gerçeker

Address:
City: İzmir
Zip: 35100
Country: Turkey

Status: Recruiting

Contact:
Last name: Gülçin Ö Gerçeker

Phone: 05306411368
Email: gulcinozalp@gmail.com

Start date: March 1, 2022

Completion date: December 30, 2024

Lead sponsor:
Agency: Dokuz Eylul University
Agency class: Other

Collaborator:
Agency: Afyonkarahisar Health Science University
Agency class: Other

Source: Dokuz Eylul University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06605339