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Completed

NCT Number: NCT05675358

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

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.

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Key information

Conditions

Virtual Reality Acute Pain Anxiety Disorders Mental Disorders Neoplasms Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Pediatric Cancer Signs and Symptoms

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker, Izmir, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  1. emotional apperance assesed by Emotional Appearance Scale for Children

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Afyonkarahisar Health Sciences University

Registry information

Acronym: VR-PHO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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