Virtual Reality Distraction During Phlebotomy in Children

NCT06336811 | Completed

• 1 other identifier: DEU active-pasive VR
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Acute; Child, Only; Anxiety and Fear

Keywords

phlebotomy; virtual reality

Outcome Measures

Primary Outcomes (4)

• procedure related pain

  Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).

  3 minutes after the phlebotomy

• anxiety

  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

  3 minutes before and after the phlebotomy

• fear

  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.

  3 minutes before and after the phlebotomy

• emotional apperance

  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. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors

  3 minutes before and after the phlebotomy

Study Arms (3)

Control

NO INTERVENTION

No additional intervention will be performed on the patient in the control group, and until the intervention begins, "How old are you?" Which grade are you in? What is the name of your favorite friend? Which sport do you enjoy doing more? His attention was distracted by asking questions such as.

active Virtual reality

EXPERIMENTAL

The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications.

Device: active virtual reality distraction

passive virtual reality

EXPERIMENTAL

It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application that will attract the attention of children was determined by the researchers.

Device: passive virtual reality distraction

Interventions

passive virtual reality distraction DEVICE

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

passive virtual reality

active virtual reality distraction DEVICE

The remote control of the virtual glasses will be given to the hand, and the child will start, slow down or stop the application herself.

active Virtual reality

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child agrees to participate in the study voluntarily.
• The parent agrees to participate in the study voluntarily.
• Obtaining consent forms from the child and parent

You may not qualify if:

• The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
• Having fever (\>37.5C) and severe dehydration
• The patient did not take analgesics before the intervention

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• Gerceker GO, Salmal N, Bektas I. The effect of active and passive virtual reality distractions on phlebotomy-related emotional behavior, pain, anxiety, and fear in children: A randomized controlled trial. J Pediatr Nurs. 2025 Jul-Aug;83:190-198. doi: 10.1016/j.pedn.2025.05.005. Epub 2025 May 12.

  PMID: 40359712 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

• Gulcin Ozalp

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Before blood collection, the "Emotional Appreance Scale for Children" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 29, 2024
• Study Start: May 30, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)