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

Primary Purpose

Pain, Acute, Fear, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality
stress ball
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gülçin Özalp Gerçeker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

virtual reality

Stress ball

control

Arm Description

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

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.

standard approach

Outcomes

Primary Outcome Measures

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).
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 30, 2023
Last Updated
May 17, 2023
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05818761
Brief Title
Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Acronym
VR-DEU22
Official Title
The Effects of Virtual Reality and Stress Ball Distraction on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Fear, Anxiety State

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual reality
Arm Type
Experimental
Arm Description
watching the application by wearing virtual glasses to the child during the phlebotomy
Arm Title
Stress ball
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
standard approach
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
wearing virtual reality glasses
Intervention Type
Behavioral
Intervention Name(s)
stress ball
Intervention Description
squeezing the stress ball during the attempt
Primary Outcome Measure Information:
Title
Pain assesed by Wong-Baker FACES
Description
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).
Time Frame
up to 5 minutes after the phelobotomy
Title
Anxiety assesed by Children Anxiety Meter-State
Description
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
up to 5 minutes after the phelobotomy
Title
Fear assesed by Child Fear Scale
Description
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.
Time Frame
up to 5 minutes after the phelobotomy
Secondary Outcome Measure Information:
Title
Emotional Appearance
Description
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.
Time Frame
up to 5 minutes after the phelobotomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülçin Özalp Gerçeker, pHD
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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