Virtual Reality Distraction During Phlebotomy in Children

Dokuz Eylul University150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

150

Conditions

Pain, Acute Child, Only Anxiety and Fear

Interventions

passive virtual reality distractionDEVICE

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

active virtual reality distractionDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Gülçin Özalp Gerçeker

Izmir, Turkey (Türkiye)

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 3 minutes before and after the phlebotomy

Data from ClinicalTrials.gov

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