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The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children

Primary Purpose

Pain, Anxiety, Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Tablet
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The child and family agree to participate in the research,
  • The child is between the ages of 5-12
  • The child does not have a chronic and mental health problem.
  • Not having a visual and hearing disability
  • No history of sedative, analgesic or narcotic substance use within 24 hours before admission
  • Not having a febrile illness at the time of application
  • Absence of a disease causing chronic pain
  • Being treated in the green area according to the 3-level (red-yellow-green) triage system.
  • Performing the operation at once

Exclusion Criteria:

  • • The child and family's refusal to participate in the research

    • Having a visual and auditory problem
    • The child is less than 5 years old or older than 12 years old
    • The child has a chronic and mental health problem
    • Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.

Sites / Locations

  • Remziye Semerci

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Virtual reality group

Tablet group

Arm Description

Children in the control group will be received standard care. Control group children will not receive any distraction techniques.

The children in the VR groups will watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, will watch Ice Age.

The children in the tablet groups will watch the video during the blood draw with tablet. They will watch Ice Age.

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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Procedure Related Fear
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Procedure Related Fear
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Procedure Related Anxiety
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Procedure Related Anxiety
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2022
Last Updated
April 10, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05588687
Brief Title
The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children
Official Title
The Effect of Two Different Distraction Methods Applied During Venous Blood Collection Procedure on the Level of Pain, Fear and Anxiety in Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya 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
The aim of this study is to determine the effect of watching cartoons with virtual reality glasses and tablets applied during the blood collection process on the level of pain, fear and anxiety experienced by children.
Detailed Description
Needle procedures applied to children for diagnosis and treatment cause fear, anxiety, and pain. In cases where children's pain and fear cannot be controlled, health professionals and parents may experience feelings of stress, helplessness, and guilt. Many approaches reduce pain and anxiety in children during painful procedures. The most commonly used of these approaches is the distraction technique, also known as the distraction technique, which is constructed with cognitive and behavioral processes. There are many methods used to divert attention. Some of those; watching cartoons, inflating balloons, creating balloons by blowing foam, directing techniques, parent coaching, using virtual reality (VR) glasses, listening to music, kaleidoscope, and using distraction cards. The research is a randomized controlled experimental study designed to determine the effects of two different methods (watching 360-degree cartoons with virtual reality glasses and watching cartoons with a tablet) during the blood collection procedure in children, on the level of pain, fear, and anxiety experienced by children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety, Fear, Venipuncture Site Reaction, Nursing Caries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental, parallel-group (intervention-control), randomized controlled design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children in the control group will be received standard care. Control group children will not receive any distraction techniques.
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
The children in the VR groups will watch the video by wearing virtual glasses during the blood draw. By wearing the VR headsets in the VR-Rollercoaster Group, will watch Ice Age.
Arm Title
Tablet group
Arm Type
Experimental
Arm Description
The children in the tablet groups will watch the video during the blood draw with tablet. They will watch Ice Age.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
Children will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear.
Intervention Type
Device
Intervention Name(s)
Tablet
Intervention Description
Children will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear.
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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Time Frame
1 minute before the blood draw procedure
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). This scale was assessed using self-report and reports from the parents, the researcher and the nurse who attempted the blood draw after the blood draw procedure in this study.
Time Frame
1 minute after the blood draw procedure
Title
Procedure Related Fear
Description
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Time Frame
1 minute before the blood draw procedure
Title
Procedure Related Fear
Description
The Child Fear Scale (CFS) used. This scale is a one-item self-report measure for measuring pain-related fear in children. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. It can be used by the parents and researchers before and during the procedure for children aged 5-10 years.CFS were administered by the researcher to the children to assess their fear levels about blood draw before and after blood draw procedure.
Time Frame
1 minute after the blood draw procedure
Title
Procedure Related Anxiety
Description
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Time Frame
1 minute before the blood draw procedure
Title
Procedure Related Anxiety
Description
The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It validated at children aged 4-10 years during an intravenous procedure.CAM were administered by the researcher to the children to assess their anxiety levels about blood draw before and after the blood draw procedure.
Time Frame
1 minute after the blood draw procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The child and family agree to participate in the research, The child is between the ages of 5-12 The child does not have a chronic and mental health problem. Not having a visual and hearing disability No history of sedative, analgesic or narcotic substance use within 24 hours before admission Not having a febrile illness at the time of application Absence of a disease causing chronic pain Being treated in the green area according to the 3-level (red-yellow-green) triage system. Performing the operation at once Exclusion Criteria: • The child and family's refusal to participate in the research Having a visual and auditory problem The child is less than 5 years old or older than 12 years old The child has a chronic and mental health problem Being treated in the red or yellow area according to the 3-level (red-yellow-green) triage system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remziye Semerci, PhD
Organizational Affiliation
Koç University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Remziye Semerci
City
Edirne
State/Province
Center
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Two Distraction Methods on the Level of Pain, Fear and Anxiety in Children

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