Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children (VR-DEU22)

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

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

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Anxiety State; Fear
• Intervention / Treatment: Device: virtual reality; Behavioral: stress ball

Detailed Description

H1: There is a difference between the groups in terms of pain, fear, anxiety and emotional appearance scores related to the intervention during the blood draw attempt.

A standard approach will be applied to all children. Standard approach; giving information about the procedure, the nurse introducing herself, choosing the area together, being with the parent and talking to the child during the procedure, "I'm starting now, I'm cleaning the area, take a deep breath, I'm applying it now, it may hurt a little, you shouldn't move, it will take a very short time, I will cover it with tape " contains.

In the virtual reality glasses group, a tourniquet will be attached to the extremity where the intervention will be performed. By wearing virtual glasses, the video will be started.

In the stress ball group, before the intervention is applied, the other hand will be given a stress ball and asked to squeeze it.

In the control group, communication with the child will continue during the intervention with the questions mentioned above.

When the nurse decides on the area where the PICT will be performed (the minute will be recorded), she will use the words "I am cleaning the area, take a deep breath, now I am applying the injection, it may hurt a little, you should not move, it will be very short".

The intervention will be stopped when the blood draw attempt fails in all groups.

5 minutes after the blood draw attempt, the child will be asked to rate the most painful moment felt during the procedure using the Facial Expressions Rating Scale. The Child Fear Scale (CDS) and Child Anxiety Scale-State (CAS-D) will be given to the child to assess how anxious and frightened he is during the procedure. The child will be asked to mark with a pencil. The Emotional Appearance Scale for Children will be evaluated by the nurse after the procedure.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gülçin Özalp Gerçeker, pHD; Phone Number: 0905306411368; Email: gulcinozalp@gmail.com
• Study Contact Backup: Name: Gülçin Özalp Gerçeker, pHD; Phone Number: 0905306411368

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Gülçin Özalp Gerçeker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The age range of children is between 6-12
• The child's consent to voluntarily participate in the study
• Parent's willingness to participate in the study voluntarily
• Obtaining consent forms from child and parent

Exclusion Criteria:

• The child has a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.
• fever (>37.5C) and severe dehydration
• The child takes analgesics before the blood draw
• Wearing glasses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: virtual reality; watching the application by wearing virtual glasses to the child during the phlebotomy	Device: virtual reality; wearing virtual reality glasses
Experimental: Stress ball; a stress ball will be given to the child's hand, and he will be asked to squeeze continuously before the blood draw attempt begins, and to continue squeezing during the procedure.	Behavioral: stress ball; squeezing the stress ball during the attempt
No Intervention: control; standard approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assesed by Wong-Baker FACES	Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).	up to 5 minutes after the phelobotomy
Anxiety assesed by Children Anxiety Meter-State	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	up to 5 minutes after the phelobotomy
Fear assesed by Child Fear Scale	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. It can be used during the procedure for children aged 5-10 years.	up to 5 minutes after the phelobotomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Appearance	Emotional Appearance Scale for Children will use. 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.	up to 5 minutes after the phelobotomy

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gülçin Özalp Gerçeker, pHD, Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Acute Pain
• Other Study ID Numbers: VR-DEU22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No