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

NCT05675358 | Completed DMC

• 1 other identifier: ASBU 2022/89
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

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.

Conditions

Virtual Reality; Pain, Acute; Pediatric Cancer

Keywords

virtual reality; phlebotomy; pain; fear; anxiety; emotional apperance

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• emotional apperance assesed by Emotional Appearance Scale for Children

  Baseline - before the phelobotomy

Study Arms (2)

virtual reality

EXPERIMENTAL

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

control

NO INTERVENTION

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

Interventions

Virtual Reality BEHAVIORAL

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

virtual reality

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• having a fever (\>37.5C) and severe dehydration
• Before the invasive procedure, the patient was given anagesics.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Afyonkarahisar Health Sciences University: collaborator

Study Sites (2)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Gülçin Özalp Gerçeker

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• Kanad N, Ozalp Gerceker G, Eker I, Sen Susam H. The effect of virtual reality on pain, fear and emotional appearance during blood draw in pediatric patients at the hematology-oncology outpatient clinic: A randomized controlled study. Eur J Oncol Nurs. 2024 Feb;68:102495. doi: 10.1016/j.ejon.2023.102495. Epub 2023 Dec 26.

  PMID: 38184927 DERIVED

MeSH Terms

Conditions

Acute Pain; Neoplasms; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülçin Özalp Gerçeker, pHD, RN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The child's pain and fear were evaluated blindly to each other by the parent and the nurse who performed the phelobotomy attempt.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: March 3, 2022
• Primary Completion: August 3, 2022
• Study Completion: September 3, 2022
• Last Updated: January 9, 2023

Record last verified: 2022-12

Locations

TU (2)