The Effect of Two Different Methods Applied During Intramuscular Injection on the Level of Pain and Fear in Children
The Effect of Use of Virtual Reality Glasses and Manual Pressure Method on the Level of Pain and Fear in Children During Intramuscular Injection
1 other identifier
interventional
75
1 country
1
Brief Summary
This study was planned to determine the effects of using virtual reality glasses and manual pressure during intramuscular injection on the level of pain and fear in children. The study will consist of children aged 6-10 years who come to the Pediatric Emergency Service injection room for prescription penicillin injection and meet the inclusion criteria. One of the main purposes of nursing care is to relieve the child's pain and improve the quality of life. In this context, it has been suggested that two different methods used by the researcher can positively affect the levels of pain and fear. For this reason, it is aimed to determine the efficiency level of two different methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedStudy Start
First participant enrolled
December 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2024
CompletedMarch 5, 2024
March 1, 2024
3 months
April 2, 2023
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Fear Scale
The purpose of the Child Fear Scale is to evaluate the fear level of children. It consisted of five facial expressions ranging from neutral expression (0 = No anxiety) to fearful expression (4 = Severe anxiety).
The child's fear level will be evaluated by 3 people (child, parent and researcher) 2 minutes before intramuscular penicillin injection is given to the whole group. This process will take 1 minute.
Secondary Outcomes (1)
Facial Expressions Pain Scale-Revised
Two minutes after intramuscular penicillin injection is given to the whole group, the child's pain will be evaluated by 3 people (child, parent and researcher). This process takes 1 minute.
Study Arms (3)
Virtual reality glasses group
EXPERIMENTALThe study group (n=25) will watch a video with virtual reality glasses during the intramuscular injection.
Manual pressure group
EXPERIMENTALIn the study group (n=25), pressure will be applied to the area to be injected for 10 seconds before the intramuscular injection procedure.
Control group
NO INTERVENTIONThe control group (n=25) will not be subjected to any application other than intramuscular injection, which is routinely applied in pediatric emergency.
Interventions
It is suggested that the use of virtual reality glasses during the injection will positively affect the pain and fear levels in children who received penicillin injection in the pediatric emergency department where the study was conducted.
In the pediatric emergency department where the study was conducted, pressure will be applied to the area to be injected for 10 seconds before the injection procedure in children who received penicillin injection. Pressing with the thumb of the hand, which will be passive in the pressing application, will be understood by the whitening of the nail, and thus pressure will be applied to the skin. It is suggested that it can positively affect pain and fear levels.
Eligibility Criteria
You may qualify if:
- Having applied to the pediatric emergency service for the administration of a penicillin antibiotic group drug,
- Absence of a significant chronic disease,
- Absence of visual and auditory disabilities,
- Having no communication problems and being conscious,
- No previous history of fainting during injection,
- Not taking analgesics in the last three hours,
- Percentile value is in the range of 3-97 points,
- Injection into the vastus lateralis muscle can be applied,
- The child's and parent's willingness to participate in the research.
You may not qualify if:
- The percentile value is below 3 and the percentile value is above 97,
- Family's inability to cooperate in the assessment of pain and fear,
- Having a diagnosed physical or mental disability,
- To have taken analgesics in the last 3 hours,
- Presence of incision and scar tissue in the area to be injected,
- The child's and parent's refusal to participate in the research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Selmin Koselead
Study Sites (1)
Selmin Köse
Istanbul, 34010, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EMINE KURTAR, RN
Adana City Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor Doctor
Study Record Dates
First Submitted
April 2, 2023
First Posted
April 27, 2023
Study Start
December 11, 2023
Primary Completion
February 29, 2024
Study Completion
February 29, 2024
Last Updated
March 5, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
Due to Hospital policy, the individual participant data can not be shared with anyone except researchers.