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Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children

Primary Purpose

Procedural Anxiety, Fear, Procedural Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Virtual reality
Local cold-vibration
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Anxiety focused on measuring procedural anxiety, fear, procedural pain, peripheral intravenous catheter, virtual reality, local-cold vibration, distraction method, nonpharmacological method

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

the child;

  • between the ages of 5-10
  • PIC application will be made
  • No visual, auditory or sensory loss
  • Mental and language deficiencies
  • Those who have not taken any analgesic medication in the last 4 hours
  • Do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital.

Exclusion Criteria:

  • Unsuccessful PIC application in the first time
  • The child in the group with local cold-vibration application removes the device during the procedure (PIC application).
  • The child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (PIC application).
  • Suspecting 'Covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)

Sites / Locations

  • Ayşegül İşler Dalgiç

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Virtual Reality Group

Local Cold-Vibration Group

Control Group

Arm Description

Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization

The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization

Routine Care

Outcomes

Primary Outcome Measures

Assessing the children's anxiety with Children's State Anxiety
The Children's State Anxiety (CAS-S). The CAS-S 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
Assessing the children's anxiety with Children's State Anxiety
The Children's State Anxiety (CAS-S). The CAS-S 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
Assessing the children's fear with 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.
Assessing the children's fear with 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.
Assessing the children's pain with 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).
Assessing children's pain with 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).

Secondary Outcome Measures

Full Information

First Posted
June 17, 2022
Last Updated
June 22, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05435105
Brief Title
Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children
Official Title
The Effect of Virtual Reality and Local Cold-Vibration Methods on Reducing Anxiety, Fear and Pain Due to Peripheral Intravenous Catheterization in Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 27, 2021 (Actual)
Study Completion Date
June 27, 2022 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This is a randomized controlled trial. The aim of the study is to the effects of Virtual Reality and Local Cold-Vibration applications in reducing anxiety, fear and pain due to intravenous catheterization (PIC) in children aged 5-10 years. PIC was found to be effective in reducing anxiety, fear and pain due to peripheral intravenous catheterization.
Detailed Description
Peripheral intravenous catheterization is an administration method that is frequently used in children and causes pain. There are different non-pharmacological methods for reducing pain due to invasive procedures. The use of non-pharmacological methods is an important part of nursing care to reduce the short and long-term negative effects of painful interventions on children.This study was planned to compare the effectiveness of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain caused by PIC in children aged 5-10 years. It was planned as a randomized controlled experimental study in pre-test, post-test design. The sample of the study was carried out in the Pediatric Emergency Unit of Akdeniz University Medical Faculty Hospital. The applicant will consist of 120 children aged 5-10 years. There will be a total of three groups in the research, 2 of which are the intervention group (virtual reality, local cold-vibration) and the control group (routine application). Data will be collected using the "Child-Parent Description Form", "Child Anxiety Scale-State Scale", "Child Fear Scale", "Wong- Baker Faces Pain Scale". Data will be collected before and within the first 5 minutes after IM injection administration. Scales; to be filled in separately by the child, one of the parents, and the nurse administering the PIC. As a result of this study, it was concluded that the use of virtual reality glasses and local cold-vibration methods are effective in reducing the pain, anxiety and fear that due to PIC placement in children aged 5-10 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Anxiety, Fear, Procedural Pain, Child, Only
Keywords
procedural anxiety, fear, procedural pain, peripheral intravenous catheter, virtual reality, local-cold vibration, distraction method, nonpharmacological method

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization
Arm Title
Local Cold-Vibration Group
Arm Type
Experimental
Arm Description
The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine Care
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
Distraction method
Intervention Type
Behavioral
Intervention Name(s)
Local cold-vibration
Intervention Description
Distraction method
Primary Outcome Measure Information:
Title
Assessing the children's anxiety with Children's State Anxiety
Description
The Children's State Anxiety (CAS-S). The CAS-S 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
Before the peripheral intravenous catheterization
Title
Assessing the children's anxiety with Children's State Anxiety
Description
The Children's State Anxiety (CAS-S). The CAS-S 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
Within the first 5 minutes after the peripheral intravenous catheterization
Title
Assessing the children's fear with 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.
Time Frame
Before the peripheral intravenous catheterization
Title
Assessing the children's fear with 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.
Time Frame
Within the first 5 minutes after the peripheral intravenous catheterization
Title
Assessing the children's pain with 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
Before the peripheral intravenous catheterization
Title
Assessing children's pain with 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
Within the first 5 minutes after the peripheral intravenous catheterization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: the child; between the ages of 5-10 PIC application will be made No visual, auditory or sensory loss Mental and language deficiencies Those who have not taken any analgesic medication in the last 4 hours Do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital. Exclusion Criteria: Unsuccessful PIC application in the first time The child in the group with local cold-vibration application removes the device during the procedure (PIC application). The child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (PIC application). Suspecting 'Covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYŞEGÜL İŞLER DALGIÇ, Professor
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Ayşegül İşler Dalgiç
City
Antalya
State/Province
Akdeniz University
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children

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