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

NCT ID: NCT06605339

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-12-30

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.

Conditions

Pediatric Cancer

Study Design

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

Study Groups

Control

The child in the control group did not receive any additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual reality

In the study, Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used, and the Epic Roller Coasters train game, an application that would attract the attention of children, was determined by the researchers. The virtual reality application was started 2 minutes before the procedure and continued until the procedure was completed.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: BEHAVIORAL

Virtual Reality Distraction

Interventions

Virtual Reality

Virtual Reality Distraction

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Science University

UNKNOWN

Sponsor Role: collaborator

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Gülçin Özalp Gerçeker

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gulcin Ozalp Gerceker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ASBU portVR

Identifier Type: -

Identifier Source: org_study_id