search
Back to results

Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety

Primary Purpose

Procedural Pain, Fear, Procedural Anxiety

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 Pain focused on measuring child, pain, anxiety, fear, intramuscular injection, local cold-vibration, virtual reality, pediatric nurse

Eligibility Criteria

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

Inclusion Criteria:

The child is between the ages of 5 and 10

Having intramuscular (IM) injection therapy

Absence of Audio-Visual-Sensation loss problem

No communication problem

Absence of mental retardation

Absence of a disease causing chronic pain

No history of fainting during injection

Not taking any analgesic medication in the last 4 hours

Exclusion Criteria:

Failure of IM application at one time

The child in the virtual reality application group removes the virtual reality glasses during the IM injection.

The child in the group receiving Buzzy application removes the Buzzy device during IM injection.

Not wanting to fill the scales after the application

Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)

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 intramuscular injection

The local cold-vibration device is placed 5 cm above the area to be injected

standart care

Outcomes

Primary Outcome Measures

Anxiety assesed by 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
Anxiety assesed by 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
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.
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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
June 16, 2022
Last Updated
June 22, 2022
Sponsor
Akdeniz University
search

1. Study Identification

Unique Protocol Identification Number
NCT05434832
Brief Title
Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety
Official Title
The Effect of Virtual Reality and Local Cold Application-Vibration Methods on Reducing Anxiety, Fear and Pain Developed During Intramuscular Injection 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
A randomized controlled trial is conducted to evaluation of the effects of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain due to intramuscular (IM) injection in children aged 5-10 years. It has been determined that the use of Virtual Reality and local cold-vibration are effective interventions in reducing anxiety, fear and pain due to IM injection in children aged 5-10 years.
Detailed Description
Intramuscular (IM) intervention is a parenteral administration method that is frequently used in children and causes pain. In cases such as inadequacies in pain management and inability to prevent pain, physiological and psychological problems that can last a lifetime can be seen in the child. 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. However, the use of non-pharmacological methods to reduce the pain perceived by the child during painful interventions in pediatric emergency units is not common in our country. No study has been found in the literature comparing the effectiveness of virtual reality and Buzzy methods in reducing anxiety, fear and pain due to invasive procedures. This study was planned to compare the effectiveness of virtual reality and local cold application-vibration applications in reducing anxiety, fear and pain caused by intramuscular injection 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 Konya Selcuk 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, Buzzy) 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 IM injection. As a result of this study, it was concluded that the use of virtual reality glasses and local cold application-vibration (Buzzy) methods are effective in reducing the pain, anxiety and fear that develop during IM injection 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 Pain, Fear, Procedural Anxiety, Child, Only
Keywords
child, pain, anxiety, fear, intramuscular injection, local cold-vibration, virtual reality, pediatric nurse

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
117 (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 intramuscular injection
Arm Title
Local cold-vibration Group
Arm Type
Experimental
Arm Description
The local cold-vibration device is placed 5 cm above the area to be injected
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
standart 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
Anxiety assesed by 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 intramuscular injection
Title
Anxiety assesed by 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 intramuscular injection
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.
Time Frame
Before the intramuscular injection
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.
Time Frame
Within the first 5 minutes after the intramuscular injection
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
Before the intramuscular injection
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
Within the first 5 minutes after the intramuscular injection

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 is between the ages of 5 and 10 Having intramuscular (IM) injection therapy Absence of Audio-Visual-Sensation loss problem No communication problem Absence of mental retardation Absence of a disease causing chronic pain No history of fainting during injection Not taking any analgesic medication in the last 4 hours Exclusion Criteria: Failure of IM application at one time The child in the virtual reality application group removes the virtual reality glasses during the IM injection. The child in the group receiving Buzzy application removes the Buzzy device during IM injection. Not wanting to fill the scales after the application Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)
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

Learn more about this trial

Effects of Virtual Reality, External Cold and Vibration to Children During IM Injection on Pain, Fear and Anxiety

We'll reach out to this number within 24 hrs