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

Sponsor
Trakya University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05588687
Collaborator
(none)
159
1
3
9
17.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual reality
  • Device: Tablet
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is an experimental, parallel-group (intervention-control), randomized controlled designThis study is an experimental, parallel-group (intervention-control), randomized controlled design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Feb 1, 2022
Actual Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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

Experimental: Virtual reality group

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.

Behavioral: Virtual reality
Children will watch Ice Age in virtual reality during blood draw and the researcher will monitor their pain, anxiety and fear.

Experimental: Tablet group

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

Device: Tablet
Children will watch Ice Age with a tablet during blood draw and the researcher will monitor their pain, anxiety and fear.

Outcome Measures

Primary Outcome Measures

  1. Pain assesed by Wong-Baker FACES [1 minute before the blood draw procedure]

    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.

  2. Pain assesed by Wong-Baker FACES [1 minute after the blood draw procedure]

    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.

  3. Procedure Related Fear [1 minute before the blood draw procedure]

    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.

  4. Procedure Related Fear [1 minute after the blood draw procedure]

    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.

  5. Procedure Related Anxiety [1 minute before the blood draw procedure]

    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.

  6. Procedure Related Anxiety [1 minute after the blood draw procedure]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Remziye Semerci Edirne Center Turkey 22030

Sponsors and Collaborators

  • Trakya University

Investigators

  • Principal Investigator: Remziye Semerci, PhD, Koç University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Remziye Semerci, Assistant Professor, Trakya University
ClinicalTrials.gov Identifier:
NCT05588687
Other Study ID Numbers:
  • Koç University
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
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 Oct 20, 2022