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

Sponsor

Dokuz Eylul University (Other)

Overall Status

Completed

CT.gov ID

NCT05675358

Collaborator

Afyonkarahisar Health Sciences University (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

34.5

Patients Per Site

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality Pain, Acute Pediatric Cancer	Behavioral: Virtual Reality	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The child's pain and fear were evaluated blindly to each other by the parent and the nurse who performed the phelobotomy attempt.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Actual Primary Completion Date :

Aug 3, 2022

Actual Study Completion Date :

Sep 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Virtual Reality Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.
No Intervention: control The child in the control group did not receive any additional intervention.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Virtual Reality

Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.

No Intervention: control

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gülçin Özalp Gerçeker	İzmir		Turkey	35100
2	Gülçin Özalp Gerçeker	İzmir		Turkey

Sponsors and Collaborators

Dokuz Eylul University
Afyonkarahisar Health Sciences University

Investigators

Principal Investigator: Gülçin Özalp Gerçeker, pHD, RN, Dokuz Eylul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University

ClinicalTrials.gov Identifier:

NCT05675358

Other Study ID Numbers:

ASBU 2022/89

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University

Additional relevant MeSH terms:

Acute Pain

Study Results

No Results Posted as of Jan 9, 2023