NCT05685082

Brief Summary

The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities. Participants will assign to two groups and will attend simulation sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

December 22, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

22 days

First QC Date

December 22, 2022

Last Update Submit

January 25, 2024

Conditions

Simulation of Physical IllnessNurse's Role

Keywords

Nursing studentSimulation-based trainingStandardized patient simulationManikin-based simulation

Outcome Measures

Primary Outcomes (2)

  • Change from baseline cultural awareness level on the 36 questions Cultural Awareness Scale

    The Cultural Awareness Scale is a validated, reliable, and self-reported instrument assessing cultural awareness levels. Each statement is graded from 1=Strongly Disagree to 7=Strongly Agree. While lower scores indicate less cultural awareness, higher scores indicate greater cultural awareness (minimum = 36, maximum = 252).

    Three hour

  • Change from baseline social determinants knowledge on the 10 questions Social Determinants of Health Survey

    Social Determinants of Health Survey is a 10-question multiple-choice survey created by researchers by searching the literature. The number of responses to the answer choice is determined. The lower scores indicate fewer social determinants of health knowledge and higher scores indicate greater social determinants of health knowledge (minimum = 0, maximum = 10).

    Three hour

Study Arms (2)

Standardized patient group

EXPERIMENTAL

The standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual

Behavioral: Standardized patient simulation

Manikin-based group

EXPERIMENTAL

The manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual

Behavioral: Manikin-based simulation

Interventions

Standardized patient simulationBEHAVIORAL

The standardized patient simulation participants will receive a simulation with standardized patients on how to identify social determinants of health in an individual

Standardized patient group
Manikin-based simulationBEHAVIORAL

The manikin-based simulation participants will receive a simulation with manikins on how to identify social determinants of health in an individual

Manikin-based group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being enrolled in Nursing in the Community course
  • accepting to be a participant
  • accepting to be recorded

You may not qualify if:

  • not attending at least one of the prebriefing, simulation, or debriefing sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Study Officials

  • Semiha Asli Bozkurt, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 13, 2023

Study Start

February 2, 2023

Primary Completion

February 24, 2023

Study Completion

June 30, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)