NCT05833854

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

April 2, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

manual pressurevirtual reality glassesintramuscular injectionpainfear

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

EXPERIMENTAL

The study group (n=25) will watch a video with virtual reality glasses during the intramuscular injection.

Other: Virtual reality glasses group

Manual pressure group

EXPERIMENTAL

In the study group (n=25), pressure will be applied to the area to be injected for 10 seconds before the intramuscular injection procedure.

Other: Manual pressure group

Control group

NO INTERVENTION

The 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.

Virtual reality glasses group

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.

Manual pressure group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

Selmin Köse

Istanbul, 34010, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • EMINE KURTAR, RN

    Adana City Training and Research Hospital

    PRINCIPAL INVESTIGATOR

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.

Locations