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

NCT06605339 | Completed DMC

• 1 other identifier: ASBU portVR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

pediatric; cancer; virtual reality; pain; fear; emotional behavior

Outcome Measures

Primary Outcomes (3)

• Pain assesed by Wong-Baker FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10

  after the port needle insertion

• Fear assesed by Child Fear Scale

  The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.

  after the port needle insertion

• emotional apperance assesed by Emotional Appearance Scale for Children

  This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5.

  after the port needle insertion

Study Arms (2)

Control

NO INTERVENTION

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

Virtual reality

EXPERIMENTAL

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.

Behavioral: Virtual Reality

Interventions

Virtual Reality BEHAVIORAL

Virtual Reality Distraction

Virtual reality

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Afyonkarahisar Health Science University: collaborator

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gulcin Ozalp Gerceker, Assoc. Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: March 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)