Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients

Not Applicable

Completed

• Conditions: Pediatric Cancer; Virtual Reality; Pain, Acute
• Interventions: Behavioral: Virtual Reality

• Registration Number: NCT05675358
• Lead Sponsor: Dokuz Eylul University

Brief Summary

In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.

Detailed Description

This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.

Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.

Study Timeline

• Study Start: 2022-03-03
• Primary Completion: 2022-08-03
• Study Completion: 2022-09-03
• Status Verified: 2022-12
• Study First Submitted: 2022-12-29
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

the age range is between 4-12

to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken

consent of the child and parent to voluntarily participate in the study

The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.

Exclusion Criteria

having a fever (>37.5C) and severe dehydration

Before the invasive procedure, the patient was given anagesics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
virtual reality	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.

Primary Outcome Measures

Name	Time	Method
Pain assesed by Wong-Baker FACES	procedure - during the phelobotomy	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
Fear assesed by Child Fear Scale	procedure -during the phelobotomy	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.
Anxiety assesed by Children Anxiety Meter-State	procedure- during the phelobotomy	The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).

Secondary Outcome Measures

Name	Time	Method
emotional apperance assesed by Emotional Appearance Scale for Children	Baseline - before the phelobotomy	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.

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey