NCT04420559

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:

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

June 1, 2020

Last Update Submit

April 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale for pain measurement

    (Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome

    4 months

Secondary Outcomes (1)

  • Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)

    4 months

Study Arms (3)

Virtual Reality

EXPERIMENTAL
Other: Intramuscular Injection

Distraction Card

EXPERIMENTAL
Other: Intramuscular Injection

Control

NO INTERVENTION

Interventions

Intramuscular Benzathine Penicillin Injection Procedure

Distraction CardVirtual Reality

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Injections, Intramuscular

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Tulay Basak

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Fundamentals of Nursing Department

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 9, 2020

Study Start

January 17, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations