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Clinical Trials/NCT06336811
NCT06336811
Completed
Not Applicable

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

Dokuz Eylul University1 site in 1 country150 target enrollmentMay 30, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Dokuz Eylul University
Enrollment
150
Locations
1
Primary Endpoint
procedure related pain
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2023
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gülçin Özalp Gerçeker

Assoc. Prof.

Dokuz Eylul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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

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.

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

Study Sites (1)

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