Comparing to Effect Two Simulation ModelsNCT05685459

Position and Communication Skills Simulation

A study testing Standard patient simulation model in people with Comparing to Effect Two Simulation Models, run by Sakarya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study was to compare two different simulation applications in developing the positioning skill, one of the most common nursing practices, and the communication skill, which forms the basis of nursing practices. Read more about this study

Who is it for?: Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Comparing to Effect Two Simulation Models
What is being tested?: Standard patient simulation model
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Feb 2022to 30 Mar 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 26 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Volunteering to participate in the research
First-year nursing students
Not have training in simulation

Who cannot join

Not meeting the inclusion criteria

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ozlem Dogu
Sakarya, Serdivan, 54050

Other trials in Turkey (Türkiye)

About this study

Official title: Position and Communication Skills Simulation: Comparison of Two Simulation Models in Nursing Student

Conditions: Comparing to Effect Two Simulation Models
Being tested: Standard patient simulation model
Keywords: Standardized patient, Simulation, Nurse, Positioning skills, Communication skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard patient simulation modelOther
Nursing students were trained with a standard patient simulation model for position and communication skills education.

Study groups in NCT05685459
Study group	Role	What they receive
Intervention	Experimental	The students involved in the intervention group were divided into subgroups, and the simulation was carried out using standardized patients. Each subgroup consisted of two students. Students were asked to practice supine and lateral recumbent positions in each scenario. Receives: Other: Standard patient simulation model
Control	No intervention	The students in the control group were divided into subgroups and practised the supine position and the lateral recumbent position with a high-fidelity manikin. Each subgroup consisted of two students. The applications lasted 5-10 minutes for each group, and after the applications, the debriefing phase was conducted, which lasted 20 minutes.

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparing of two simulation models
Describing the performance scores of the students in the standardized patient group and the high-fidelity simulation manikin group.
The checklist consisted of 20 steps. The student scored "0" if "the step was not applied at all" or "the step was applied incorrectly." If the "step was not fully implemented", it was graded with "1" point, and "if the step was performed correctly and completely," it was graded with "2" points. Checklists were filled out by an independent observer, who was not a researcher. Scores that can be obtained from the skill checklist ranged between 0 and 80, which were converted to 100 points.
Measured: 1 month

Secondary outcomes (2)

Therapeutic Communication Skills Questionnaire for Nursing Students
Therapeutic Communication Skills Questionnaire for Nursing Students: It is a 7-point Likert-type scale and consists of 16 items and three sub-dimensions. The highest total score that can be obtained from the scale is 112, which shows high therapeutic communication skills.
Measured: 1 month
The Student Satisfaction and Self-Confidence Scale
The Student Satisfaction and Self-Confidence Scale: The scale has a 5-point Likert-type evaluation structure and consists of 13 items and two sub-dimensions. The highest total score that can be obtained from the scale is 65, which means high satisfaction and self-confidence.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202230 Mar 2022

First posted17 Jan 2023
Study start1 Feb 2022
Primary completion1 Mar 2022
Study completion30 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Comparing to Effect Two Simulation ModelsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: The population of the study consisted of 112 second-semester nursing students who took the "Nursing Fundamentals" course in the spring semester of the 2021-2022 academic year, and the sample included volunteers who took the course for the first time. A power analysis was performed on the G\*Power (v3.1.7) software to determine the sample size. The power of a study is expressed as 1-β (β = probability of type II error), and in general, studies should have 80% power. According to Cohen's effect size coefficients, assuming that the evaluations between two independent groups would have a large effect size (d = 0.8), the sample size was calculated as 60 subjects. Students were randomly assigned to groups using computer software.
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05685459
Sponsor's protocol ID: Comparison Simulation Models
Status last verified: Jan 2023
First submitted: 24 Dec 2022
Last updated: 17 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Berman, A.,Snyder, S., &Frandsen, G. (2016). Fundamentals of nursing: concept, process, andpractice (10th ed.). New Jersey: Pearson.
Potter, P.A., Perry, A.G., &Stockert, P.A. Fundamentals of nursing(10, revised ed.). (2021). St. Louis:Elsevier.
Wilfong DN, Falsetti DJ, McKinnon JL, Daniel LH, Wan QC. The effects of virtual intravenous and patient simulator training compared to the traditional approach of teaching nurses: a research project on peripheral i.v. catheter insertion. J Infus Nurs. 2011 Jan-Feb;34(1):55-62. doi: 10.1097/NAN.0b013e31820219e2.
PubMed 21239952
McWilliams LA, Malecha A. Comparing Intravenous Insertion Instructional Methods with Haptic Simulators. Nurs Res Pract. 2017;2017:4685157. doi: 10.1155/2017/4685157. Epub 2017 Jan 29.
PubMed 28250987
Vidal VL, Ohaeri BM, John P, Helen D. Virtual reality and the traditional method for phlebotomy training among college of nursing students in Kuwait: implications for nursing education and practice. J Infus Nurs. 2013 Sep-Oct;36(5):349-55. doi: 10.1097/NAN.0b013e318243172f.
PubMed 24006114
Ignacio J, Dolmans D, Scherpbier A, Rethans JJ, Chan S, Liaw SY. Comparison of standardized patients with high-fidelity simulators for managing stress and improving performance in clinical deterioration: A mixed methods study. Nurse Educ Today. 2015 Dec;35(12):1161-8. doi: 10.1016/j.nedt.2015.05.009. Epub 2015 May 23.
PubMed 26047602
Uzen Cura S, Kocatepe V, Yildirim D, Kucukakgun H, Atay S, Unver V. Examining Knowledge, Skill, Stress, Satisfaction, and Self-Confidence Levels of Nursing Students in Three Different Simulation Modalities. Asian Nurs Res (Korean Soc Nurs Sci). 2020 Aug;14(3):158-164. doi: 10.1016/j.anr.2020.07.001. Epub 2020 Jul 9.
PubMed 32653666
Doolen J, Giddings M, Johnson M, Guizado de Nathan G, O Badia L. An evaluation of mental health simulation with standardized patients. Int J Nurs Educ Scholarsh. 2014 Mar 12;11:/j/ijnes.2014.11.issue-1/ijnes-2013-0075/ijnes-2013-0075.xml. doi: 10.1515/ijnes-2013-0075.
PubMed 24620017
Quail M, Brundage SB, Spitalnick J, Allen PJ, Beilby J. Student self-reported communication skills, knowledge and confidence across standardised patient, virtual and traditional clinical learning environments. BMC Med Educ. 2016 Feb 27;16:73. doi: 10.1186/s12909-016-0577-5.
PubMed 26919838
Olaussen C, Heggdal K, Tvedt CR. Elements in scenario-based simulation associated with nursing students' self-confidence and satisfaction: A cross-sectional study. Nurs Open. 2019 Sep 27;7(1):170-179. doi: 10.1002/nop2.375. eCollection 2020 Jan.
PubMed 31871700
MacLean S, Kelly M, Geddes F, Della P. Use of simulated patients to develop communication skills in nursing education: An integrative review. Nurse Educ Today. 2017 Jan;48:90-98. doi: 10.1016/j.nedt.2016.09.018. Epub 2016 Sep 28.
PubMed 27741440
Cabanero-Martinez MJ, Garcia-Sanjuan S, Escribano S, Fernandez-Alcantara M, Martinez-Riera JR, Julia-Sanchis R. Mixed-method study on the satisfaction of a high-fidelity simulation program in a sample of nursing-degree students. Nurse Educ Today. 2021 May;100:104858. doi: 10.1016/j.nedt.2021.104858. Epub 2021 Mar 6.
PubMed 33713986

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Position and Communication Skills Simulation: Comparison of Two Simulation Models in Nursing Student
ClinicalTrials.gov ID: NCT05685459
Acronym / sponsor ID: Comparison Simulation Models
Conditions: Comparing to Effect Two Simulation Models
Keywords: Standardized patient, Simulation, Nurse, Positioning skills, Communication skills
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Sakarya UniversityUniversity, hospital or other
Study start: 1 Feb 2022 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 30 Mar 2022 (actual)
First posted: 17 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The population of the study consisted of 112 second-semester nursing students who took the "Nursing Fundamentals" course in the spring semester of the 2021-2022 academic year, and the sample included volunteers who took the course for the first time. A power analysis was performed on the G*Power (v3.1.7) software to determine the sample size. The power of a study is expressed as 1-β (β = probability of type II error), and in general, studies should have 80% power. According to Cohen's effect size coefficients, assuming that the evaluations between two independent groups would have a large effect size (d = 0.8), the sample size was calculated as 60 subjects. Students were randomly assigned to groups using computer software.

Arm	Type	Receives
Intervention	Experimental	Other: Standard patient simulation modelThe students involved in the intervention group were divided into subgroups, and the simulation was carried out using standardized patients. Each subgroup consisted of two students. Students were asked to practice supine and lateral recumbent positions in each scenario.
Control	No intervention	–The students in the control group were divided into subgroups and practised the supine position and the lateral recumbent position with a high-fidelity manikin. Each subgroup consisted of two students. The applications lasted 5-10 minutes for each group, and after the applications, the debriefing phase was conducted, which lasted 20 minutes.

Who may qualify

Ages: 18 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Volunteering to participate in the research
First-year nursing students
Not have training in simulation

Key exclusion criteria (1 listed)

Not meeting the inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard patient simulation modelNursing students were trained with a standard patient simulation model for position and communication skills education.	Other	Intervention

Primary outcome

Comparing of two simulation models
Time frame: 1 month
Describing the performance scores of the students in the standardized patient group and the high-fidelity simulation manikin group. The checklist consisted of 20 steps. The student scored "0" if "the step was not applied at all" or "the step was applied incorrectly." If the "step was not fully implemented", it was graded with "1" point, and "if the step was performed correctly and completely," it was graded with "2" points. Checklists were filled out by an independent observer, who was not a researcher. Scores that can be obtained from the skill checklist ranged between 0 and 80, which were converted to 100 points.

2 secondary outcomes

Therapeutic Communication Skills Questionnaire for Nursing Students
Time frame: 1 month
The Student Satisfaction and Self-Confidence Scale
Time frame: 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
BackgroundBerman, A.,Snyder, S., &Frandsen, G. (2016). Fundamentals of nursing: concept, process, andpractice (10th ed.). New Jersey: Pearson.
BackgroundPotter, P.A., Perry, A.G., &Stockert, P.A. Fundamentals of nursing(10, revised ed.). (2021). St. Louis:Elsevier.
Results publication: PubMed 21239952Wilfong DN, Falsetti DJ, McKinnon JL, Daniel LH, Wan QC. The effects of virtual intravenous and patient simulator training compared to the traditional approach of teaching nurses: a research project on peripheral i.v. catheter insertion. J Infus Nurs. 2011 Jan-Feb;34(1):55-62. doi: 10.1097/NAN.0b013e31820219e2.
Results publication: PubMed 28250987McWilliams LA, Malecha A. Comparing Intravenous Insertion Instructional Methods with Haptic Simulators. Nurs Res Pract. 2017;2017:4685157. doi: 10.1155/2017/4685157. Epub 2017 Jan 29.
Results publication: PubMed 24006114Vidal VL, Ohaeri BM, John P, Helen D. Virtual reality and the traditional method for phlebotomy training among college of nursing students in Kuwait: implications for nursing education and practice. J Infus Nurs. 2013 Sep-Oct;36(5):349-55. doi: 10.1097/NAN.0b013e318243172f.
Results publication: PubMed 26047602Ignacio J, Dolmans D, Scherpbier A, Rethans JJ, Chan S, Liaw SY. Comparison of standardized patients with high-fidelity simulators for managing stress and improving performance in clinical deterioration: A mixed methods study. Nurse Educ Today. 2015 Dec;35(12):1161-8. doi: 10.1016/j.nedt.2015.05.009. Epub 2015 May 23.
Results publication: PubMed 32653666Uzen Cura S, Kocatepe V, Yildirim D, Kucukakgun H, Atay S, Unver V. Examining Knowledge, Skill, Stress, Satisfaction, and Self-Confidence Levels of Nursing Students in Three Different Simulation Modalities. Asian Nurs Res (Korean Soc Nurs Sci). 2020 Aug;14(3):158-164. doi: 10.1016/j.anr.2020.07.001. Epub 2020 Jul 9.
Results publication: PubMed 24620017Doolen J, Giddings M, Johnson M, Guizado de Nathan G, O Badia L. An evaluation of mental health simulation with standardized patients. Int J Nurs Educ Scholarsh. 2014 Mar 12;11:/j/ijnes.2014.11.issue-1/ijnes-2013-0075/ijnes-2013-0075.xml. doi: 10.1515/ijnes-2013-0075.
Results publication: PubMed 26919838Quail M, Brundage SB, Spitalnick J, Allen PJ, Beilby J. Student self-reported communication skills, knowledge and confidence across standardised patient, virtual and traditional clinical learning environments. BMC Med Educ. 2016 Feb 27;16:73. doi: 10.1186/s12909-016-0577-5.
Results publication: PubMed 31871700Olaussen C, Heggdal K, Tvedt CR. Elements in scenario-based simulation associated with nursing students' self-confidence and satisfaction: A cross-sectional study. Nurs Open. 2019 Sep 27;7(1):170-179. doi: 10.1002/nop2.375. eCollection 2020 Jan.
Results publication: PubMed 27741440MacLean S, Kelly M, Geddes F, Della P. Use of simulated patients to develop communication skills in nursing education: An integrative review. Nurse Educ Today. 2017 Jan;48:90-98. doi: 10.1016/j.nedt.2016.09.018. Epub 2016 Sep 28.
Results publication: PubMed 33713986Cabanero-Martinez MJ, Garcia-Sanjuan S, Escribano S, Fernandez-Alcantara M, Martinez-Riera JR, Julia-Sanchis R. Mixed-method study on the satisfaction of a high-fidelity simulation program in a sample of nursing-degree students. Nurse Educ Today. 2021 May;100:104858. doi: 10.1016/j.nedt.2021.104858. Epub 2021 Mar 6.
A Technological Step in Nursing Education: Intramuscular Injection ventro-simLink provided by the sponsor.
Using standardized patients to improve the hygiene care skills of first-year nursing students: A randomized controlled trialLink provided by the sponsor.
Effects of Simulation-based Education on Communication Skill and Clinical Competence in Maternity Nursing PracticumLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Şengül ÜZEN CURA, Doctorate study chair

Çanakkale On Sekiz Mart University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standard patient simulation model in people with Comparing to Effect Two Simulation Models, run by Sakarya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing of two simulation models (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05685459, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.