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Clinical Trials/NCT05675358
NCT05675358
Completed
N/A

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

Dokuz Eylul University1 site in 1 country69 target enrollmentMarch 3, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Dokuz Eylul University
Enrollment
69
Locations
1
Primary Endpoint
Pain assesed by Wong-Baker FACES
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2022
End Date
September 3, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Dokuz Eylul University

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.

Outcomes

Primary Outcomes

Pain assesed by Wong-Baker FACES

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • emotional apperance assesed by Emotional Appearance Scale for Children(Baseline - before the phelobotomy)

Study Sites (1)

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