NCT05496946

Brief Summary

In the literature, it is emphasized that the use of simulation improves the communication skills of the participants and that teamwork is important in providing patient safety and effective care. It is stated that students experience fear and anxiety in practice due to their lack of knowledge and clinical experience. Continuous repetitions and regular feedback provided by the trainings made by applying simulation increase the performance and self-confidence of the student. It is stated that the possibility of repeated application reduces the anxiety of the students. It is seen that different simulation types are used in the development of skills in nursing students in studies on this subject. As a result; It is seen that simulation has unlimited potential as an educational method and tool in nursing education. However; No study was found on a specific nursing practice and within the simulation scenario. of the study; In this study, it is aimed to evaluate the effectiveness of using standardized/simulated patient and low-fidelity patient models in head bath practice, which is one of the basic skills of nursing students. As a result of this study, the effective training method in the teaching of the head bath skill, which is taught within the scope of the nursing principles course, will be determined. In addition, it is thought that the periodical follow-up of the students (right after the teaching and at the end of the semester) and the permanence level of this education include a different aspect from other studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

Study Start

First participant enrolled

December 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 5, 2022

Last Update Submit

August 9, 2022

Conditions

Keywords

Nurse-Patient Relationssimulationstandardized patient

Outcome Measures

Primary Outcomes (2)

  • Standardized patient

    It is expected that the education method based on standard patient practice will be more effective in change the Spielberger State and Trait Anxiety Scale scores related to head washing skills in nursing students. The Spielberger State and Trait Anxiety Inventory is used to collect data about students' anxiety levels. It consists of a total of 40 items and two parts, namely "State Anxiety Inventory" and "Trait Anxiety Inventory". The State and Trait Anxiety Inventory consists of 40 items. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety.

    3 months

  • Model with Low Closeness to Reality

    It is expected that the Modified Simulation Effectiveness Tool score will be change for the nursing students who practice the skill on the model, whose closeness to reality is low in the teaching of the head bath skill. This tool consists of 19 items. The score range of the vehicle is between 18-95. An increase in the score obtained from this tool indicates that the skill performed on the simulation is effective.

    3 months

Study Arms (2)

Model with low proximity to reality group

EXPERIMENTAL

The students included in the experimental group 1 practiced the head bathing skill on a model with low proximity to reality. The model used here is a human model belonging to the Gaumard Scientific company with low proximity to reality.

Other: Head bathing skill

Standardized patient Group

EXPERIMENTAL

The students in the experimental group 2 practiced the head bath skill on the standardized patient. A standardized patient is a healthy individual pretending to be a patient.

Other: Head bathing skill

Interventions

A group of students will practice the head bathing skill in a model with low proximity to reality, while the students in the other group will practice on a healthy individual (Standardized patient) pretending to be patient.

Model with low proximity to reality groupStandardized patient Group

Eligibility Criteria

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

You may qualify if:

  • Being a first year student of a nursing undergraduate program,
  • To be taking the Nursing Basic Principles and Practices course for the first time,
  • Getting a score of at least 80 and above in the Pre-Test for Measuring Head Bath Knowledge Levels, and
  • To volunteer to participate in the study.

You may not qualify if:

  • To not volunteer to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University- Faculty of Health Sciences

Istanbul, Kartal, Turkey (Türkiye)

Location

Related Publications (10)

  • Cant RP, Cooper SJ. Simulation-based learning in nurse education: systematic review. J Adv Nurs. 2010 Jan;66(1):3-15. doi: 10.1111/j.1365-2648.2009.05240.x.

    PMID: 20423432BACKGROUND
  • Alinier G. A typology of educationally focused medical simulation tools. Med Teach. 2007 Oct;29(8):e243-50. doi: 10.1080/01421590701551185.

    PMID: 18236268BACKGROUND
  • Bradley P. The history of simulation in medical education and possible future directions. Med Educ. 2006 Mar;40(3):254-62. doi: 10.1111/j.1365-2929.2006.02394.x.

    PMID: 16483328BACKGROUND
  • Klipfel JM, Carolan BJ, Brytowski N, Mitchell CA, Gettman MT, Jacobson TM. Patient safety improvement through in situ simulation interdisciplinary team training. Urol Nurs. 2014 Jan-Feb;34(1):39-46.

    PMID: 24716380BACKGROUND
  • Leighton K, Ravert P, Mudra V, Macintosh C. Updating the Simulation Effectiveness Tool: Item Modifications and Reevaluation of Psychometric Properties. Nurs Educ Perspect. 2015 Sep-Oct;36(5):317-23. doi: 10.5480/15-1671.

    PMID: 26521501BACKGROUND
  • Maran NJ, Glavin RJ. Low- to high-fidelity simulation - a continuum of medical education? Med Educ. 2003 Nov;37 Suppl 1:22-8. doi: 10.1046/j.1365-2923.37.s1.9.x.

    PMID: 14641635BACKGROUND
  • McCaughey CS, Traynor MK. The role of simulation in nurse education. Nurse Educ Today. 2010 Nov;30(8):827-32. doi: 10.1016/j.nedt.2010.03.005. Epub 2010 May 16.

    PMID: 20483188BACKGROUND
  • Wilford A, Doyle TJ. Integrating simulation training into the nursing curriculum. Br J Nurs. 2006 Sep 28-Oct 11;15(17):926-30. doi: 10.12968/bjon.2006.15.17.21907.

    PMID: 17077785BACKGROUND
  • Yoo MS, Yoo IY. The effectiveness of standardized patients as a teaching method for nursing fundamentals. J Nurs Educ. 2003 Oct;42(10):444-8. doi: 10.3928/0148-4834-20031001-06.

    PMID: 14577730BACKGROUND
  • Stefanski RR, Rossler KL. Preparing the novice critical care nurse: a community-wide collaboration using the benefits of simulation. J Contin Educ Nurs. 2009 Oct;40(10):443-51; quiz 452-3. doi: 10.3928/00220124-20090923-03.

    PMID: 19831325BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
For randomization, a randomization table was created using the http://stattrek.com/statistics/random-numbergenerator.aspx site. As a result, the sample of the research; The purpose of the study was explained, and after the briefing, a total of 80 students, 40 students in both groups, who were allowed to participate in the research and who met the criteria for inclusion in the sample, formed.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The sample size of the study; Using the G\* Power 3.1.9.2 program, the mean and standard deviation of a similar study in the literature (İlaslan, 2019) (Spielberger State Anxiety Scale total score mean=28.8; SD=5.4 and Spielberger State Anxiety Scale total score mean=39, 5; SD=10.4). For the calculated effect size=0.91, α=0.05 and power=0.95, it was determined that there should be at least 33 students in both groups, for a total of 66 students. Students in the sample group were randomly assigned by the researcher to the Low-Reality Model (Experimental-1 Group) and Standardized Patient (Experimental-2 Group) groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 5, 2022

First Posted

August 11, 2022

Study Start

December 25, 2021

Primary Completion

February 8, 2022

Study Completion

July 30, 2022

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations