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

Primary Purpose

Virtual Reality, Pain, Acute, Pediatric Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Virtual Reality focused on measuring virtual reality, phlebotomy, pain, fear, anxiety, emotional apperance

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Gülçin Özalp Gerçeker
  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

virtual reality

control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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
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.
Anxiety assesed by Children Anxiety Meter-State
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
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.

Full Information

First Posted
December 29, 2022
Last Updated
December 29, 2022
Sponsor
Dokuz Eylul University
Collaborators
Afyonkarahisar Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05675358
Brief Title
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Acronym
VR-PHO
Official Title
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
September 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Afyonkarahisar Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Pain, Acute, Pediatric Cancer
Keywords
virtual reality, phlebotomy, pain, fear, anxiety, emotional apperance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
The child in the control group did not receive any additional intervention.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality
Intervention Description
Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.
Primary Outcome Measure Information:
Title
Pain assesed by Wong-Baker FACES
Description
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
Time Frame
procedure - during the phelobotomy
Title
Fear assesed by Child Fear Scale
Description
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.
Time Frame
procedure -during the phelobotomy
Title
Anxiety assesed by Children Anxiety Meter-State
Description
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).
Time Frame
procedure- during the phelobotomy
Secondary Outcome Measure Information:
Title
emotional apperance assesed by Emotional Appearance Scale for Children
Description
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.
Time Frame
Baseline - before the phelobotomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD, RN
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
Country
Turkey

12. IPD Sharing Statement

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

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