Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

NCT05818761 | Completed

• 1 other identifier: VR-DEU22
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study was planned to evaluate the effects of distraction methods, using virtual reality or a stress ball, on the emotional appearance, pain, fear, and anxiety associated with the procedure, during the phlebotomy in children aged 6-12 in a private blood collection unit.

Conditions

Pain, Acute; Fear; Anxiety State

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. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).

  up to 5 minutes after 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). This scale ranges from 0 to 10. Higher values represent higher anxiety

  up to 5 minutes after the phelobotomy

• Fear assesed by Child Fear Scale

  The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.

  up to 5 minutes after the phelobotomy

Secondary Outcomes (1)

• Emotional Appearance

  up to 5 minutes after the phelobotomy

Study Arms (3)

virtual reality

EXPERIMENTAL

watching the application by wearing virtual glasses to the child during the phlebotomy

Device: virtual reality

Stress ball

EXPERIMENTAL

a stress ball will be given to the child's hand, and he will be asked to squeeze continuously before the blood draw attempt begins, and to continue squeezing during the procedure.

Behavioral: stress ball

control

NO INTERVENTION

standard approach

Interventions

virtual reality DEVICE

wearing virtual reality glasses

virtual reality

stress ball BEHAVIORAL

squeezing the stress ball during the attempt

Stress ball

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The age range of children is between 6-12
• The child's consent to voluntarily participate in the study
• Parent's willingness to participate in the study voluntarily
• Obtaining consent forms from child and parent

You may not qualify if:

• The child has a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.
• fever (\>37.5C) and severe dehydration
• The child takes analgesics before the blood draw
• Wearing glasses

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Gerceker GO, Bektas I, Yardimci F. The effects of virtual reality and stress ball distraction on procedure-related emotional appearance, pain, fear, and anxiety during phlebotomy in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:197-204. doi: 10.1016/j.pedn.2024.08.029. Epub 2024 Sep 17.

  PMID: 39293201 DERIVED

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Gülçin Özalp Gerçeker, pHD

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Model Details: Randomised

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 19, 2023
• Study Start: November 1, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)