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

Pain, Acute Clinical Trial

— VR-PHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675358
• Other study ID #: ASBU 2022/89
• Status: Completed
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: September 3, 2022

Study information

• Verified date: December 2022
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Pediatric Cancer
• Virtual Reality

Intervention

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

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	procedure - during the phelobotomy
Primary	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.	procedure -during the phelobotomy
Primary	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).	procedure- during the phelobotomy
Secondary	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.	Baseline - before the phelobotomy