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EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN

Primary Purpose

Pain, Acute, Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
video game playing, kaleidoscope and virtual reality glasses
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Acute focused on measuring Pain, Anxiety, Distraction, Children, Intramuscular injection

Eligibility Criteria

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

Inclusion Criteria: Children between the ages of 6-12 and their families who speak Turkish and accepted the voluntary informed consent form verbally and in writing. Children who do not have a chronic disease (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.) Children who have not taken an analgesic drug in the last 6 hours No physical or mental illness Children who have no suspicion of covid 19 transmission in their family or themselves Children whose vital signs are in parameters suitable for their age will be taken. Exclusion Criteria: Children who did not accept the voluntary informed consent form verbally and in writing Children with chronic diseases (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.) Children who have taken an analgesic drug in the past 6 hours Those who have a suspected covid 19 transmission in their family or themselves Children with any physical or mental illness will not be included.

Sites / Locations

  • Senem Merve KURT

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

distraction method

distraction

distraction methods

Arm Description

video game playing

kaleidoscope

virtual reality glasses

Outcomes

Primary Outcome Measures

Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Pain was measured by Wong- Baker Faces Pain Scale
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Fear was measured by Child Fear Scale
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2023
Last Updated
August 23, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT06011668
Brief Title
EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN
Official Title
THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin 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 thesis study was conducted in an unblinded, randomized controlled experimental manner in order to analyze the effect of attention-drawing methods that can be used during intramuscular injection in children on pain and anxiety.
Detailed Description
Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and Research Hospital between October and December 2021. Children aged 6-12 years were included in the study. In the study, the sample was divided into four groups. The study consisted of 180 children, 45 children in each group. Using the randomization program, it was determined which sample group the children would be included in. In the study, video game playing, kaleidoscope and virtual reality glasses were used as a distraction method for the experimental group. Intramuscular injection (IM) was applied to the control group without any application. The research implementation period lasted an average of one minute. Required ethical permissions were obtained prior to the research. Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale (CFS) was used to measure anxiety level in the study. Explanatory information about the application to be made to the children and their parents was given by the researcher, and the consent form was signed by informing them voluntarily. The research data were collected by the researcher by interviewing the children face to face. In line with the data obtained in the study, it was concluded that the descriptive characteristics of the children in the experimental and control groups were similar (p>0.05). It was concluded that playing video games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in the study, reduced pain and anxiety. It is expected that techniques that reduce pain and anxiety when intramuscular injections are given to children in nursing practices will be used in practice and that these practices will be included in the training of nurses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Anxiety and Fear
Keywords
Pain, Anxiety, Distraction, Children, Intramuscular injection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
distraction method
Arm Type
Experimental
Arm Description
video game playing
Arm Title
distraction
Arm Type
Experimental
Arm Description
kaleidoscope
Arm Title
distraction methods
Arm Type
Experimental
Arm Description
virtual reality glasses
Intervention Type
Device
Intervention Name(s)
video game playing, kaleidoscope and virtual reality glasses
Intervention Description
This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.
Primary Outcome Measure Information:
Title
Pain was measured by Wong- Baker Faces Pain Scale
Description
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Time Frame
at 1st minute before the procedure
Title
Pain was measured by Wong- Baker Faces Pain Scale
Description
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Time Frame
during the procedure
Title
Pain was measured by Wong- Baker Faces Pain Scale
Description
The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
Time Frame
at 1st minute after the procedure
Title
Fear was measured by Child Fear Scale
Description
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Time Frame
at 1st minute before the procedure
Title
Fear was measured by Child Fear Scale
Description
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Time Frame
during the procedure
Title
Fear was measured by Child Fear Scale
Description
In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
Time Frame
at 1st minute after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children between the ages of 6-12 and their families who speak Turkish and accepted the voluntary informed consent form verbally and in writing. Children who do not have a chronic disease (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.) Children who have not taken an analgesic drug in the last 6 hours No physical or mental illness Children who have no suspicion of covid 19 transmission in their family or themselves Children whose vital signs are in parameters suitable for their age will be taken. Exclusion Criteria: Children who did not accept the voluntary informed consent form verbally and in writing Children with chronic diseases (Children with chronic diseases such as DM, asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as their response levels to pain will vary.) Children who have taken an analgesic drug in the past 6 hours Those who have a suspected covid 19 transmission in their family or themselves Children with any physical or mental illness will not be included.
Facility Information:
Facility Name
Senem Merve KURT
City
Mersin
State/Province
Merkez
ZIP/Postal Code
33010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN

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