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Completed

NCT Number: NCT06336811

Virtual Reality Distraction During Phlebotomy in Children

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.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Disorders Anxiety and Fear Child, Only Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

passive virtual reality distraction

Device

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

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.

Primary outcomes

  1. procedure related pain

    Time frame: 3 minutes after the phlebotomy

    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).

  2. anxiety

    Time frame: 3 minutes before and after the phlebotomy

    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. fear

    Time frame: 3 minutes before and after the phlebotomy

    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.

  4. emotional apperance

    Time frame: 3 minutes before and after the phlebotomy

    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

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

The Effects of Virtual Reality on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

Acronym: activeVR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

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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