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NCT Number: NCT06605339

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

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.

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Key information

Conditions

Pediatric Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Behavioral

Virtual Reality Distraction

Primary outcomes

  1. Pain assesed by Wong-Baker FACES

    Time frame: after the port needle insertion

    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

  2. Fear assesed by Child Fear Scale

    Time frame: after the port needle insertion

    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.

  3. emotional apperance assesed by Emotional Appearance Scale for Children

    Time frame: after the port needle insertion

    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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Afyonkarahisar Health Sciences University

Registry information

Official study title

Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 20, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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