Intramuscular Benzathine Penicillin Injection Procedure

April 16, 2024 updated by: Tulay Basak, Saglik Bilimleri Universitesi

The Use of Virtual Reality and Distraction Cards to Reduce Pain During Intramuscular Benzathine Penicillin Injection Procedure in Adults: A Randomized Controlled Trial

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:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Virtual Reality
Other: Intramuscular Injection
Intramuscular Benzathine Penicillin Injection Procedure
Experimental: Distraction Card
Other: Intramuscular Injection
Intramuscular Benzathine Penicillin Injection Procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Tulay Basak, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 18/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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