Intramuscular Benzathine Penicillin Injection Procedure | NCT04420559

Studies
Intramuscular Benzathine Penicillin Injection Procedure

NCT04420559

Sponsor

Saglik Bilimleri Universitesi

Status

Completed

Last Update Posted

Apr 17, 2024Actual

Enrollment

91Actual

Phase

Not Applicable

Conditions

Injection Site Discomfort

Interventions

Intramuscular Injection

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2018Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Apr 30, 2018Actual

First Submitted Date

Jun 1, 2020

First Submission Date that Met QC Criteria

Jun 5, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tulay Basak, Head of Fundamentals of Nursing Department, Saglik Bilimleri UniversitesiPrincipal Investigator

Lead Sponsor

Saglik Bilimleri UniversitesiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was the determination of the effect of applying VR and DC distraction methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.

The research hypothesis:

Are Virtual Reality and Distraction Card effective in reducing pain due to injection of IM benzathine penicillin?
Does the use of Virtual Reality and Distraction Card during the injection process of IM benzathine penicillin have an effect on patient satisfaction?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Virtual Reality	Experimental	Other: Intramuscular Injection
Distraction Card	Experimental	Other: Intramuscular Injection
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intramuscular Injection	Other	Intramuscular Benzathine Penicillin Injection Procedure	Distraction Card Virtual Reality

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale for pain measurement	(Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome	4 months

Secondary Outcomes

Measure	Description	Time Frame
Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)	(Minimum score: 0 ; Maximum score:10) Higher scores mean a better outcome	4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

agree to participate in the research,
being over the age of 18,
being native speaker,
not having vision and hearing problems,
being prescribed benzathine penicillin with a dose of 1.200.000 IU,
being experienced of IM injection,
not having IM injection for the last 1 month

Exclusion Criteria:

volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the VG site
volunteers are excluded if the injection process cannot be performed at one time

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tulay Basak	Saglik Bilimleri Universitesi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gulhane Training and Research Hospital		Ankara		06010	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33608955	Derived	Basak T, Demirtas A, Yorubulut SM. Virtual reality and distraction cards to reduce pain during intramuscular benzathine penicillin injection procedure in adults: A randomized controlled trial. J Adv Nurs. 2021 May;77(5):2511-2518. doi: 10.1111/jan.14782. Epub 2021 Feb 19.

ID	Term
D007267	Injections
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics