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

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05818761
Collaborator
(none)
150
1
3
12
12.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: virtual reality
  • Behavioral: stress ball
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
RandomisedRandomised
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Virtual Reality and Stress Ball Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pain assesed by Wong-Baker FACES [up to 5 minutes after the phelobotomy]

    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).

  2. Anxiety assesed by Children Anxiety Meter-State [up to 5 minutes after the phelobotomy]

    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 assesed by Child Fear Scale [up to 5 minutes after the phelobotomy]

    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.

Secondary Outcome Measures

  1. Emotional Appearance [up to 5 minutes after the phelobotomy]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gülçin Özalp Gerçeker İzmir Turkey 35100

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gülçin Özalp Gerçeker, pHD, Assoc. Prof., Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05818761
Other Study ID Numbers:
  • VR-DEU22
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023