Virtual Reality Distraction During Phlebotomy in Children

NCT ID: NCT06336811

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The data of the study was collected with Socio-demographic Data Collection Form, Emotional Appearance Scale for Children, Facial Expression Rating Scale, Child Anxiety Scale-State, and Child Fear Scale. Demographic data and mean scores obtained from the scales were compared between the virtual reality groups, and the control group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Acute Child, Only Anxiety and Fear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

active Virtual reality

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.

Group Type EXPERIMENTAL

active virtual reality distraction

Intervention Type 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.

passive virtual reality

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.

Group Type EXPERIMENTAL

passive virtual reality distraction

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

passive virtual reality distraction

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

Intervention Type DEVICE

active virtual reality distraction

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gülçin Özalp Gerçeker

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gulcin Ozalp

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40359712 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEU active-pasive VR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality Distraction in Pediatric Patients.
NCT06355492 NOT_YET_RECRUITING PHASE4