NCT06711484

Brief Summary

Brief Summary: This research is a randomized, pre-test post-test control group, parallel group experimental study to evaluate the effectiveness of the language training program developed for newly graduated nurses. The study will be conducted with a total of 76 newly graduated nurses, 38 in the experimental group and 38 in the control group, at Etlik City Hospital Orthopedics-Neurology Hospital in Ankara. Participants will be informed about the study at the beginning of the study. Participants who agree to participate in the study and meet the eligibility criteria will be randomly assigned to groups by an independent statistician. The language training program will be applied to the experimental group, while no intervention will be made to the control group. The training program to be given to the experimental group will consist of a total of two days and four sessions (communication, speaking, patient safety, medical error), and each session will last 90 minutes. Data collection forms will be applied to the experimental and control groups before and after the training. Data collection forms include the descriptive characteristics form, working voice scale, effective communication skills scale, attitude scale in medical errors, and feedback about the language training program. Blinding of the raters will be applied to the participants to minimize bias. Data analysis will use statistical software that uses parametric tests for normally distributed data and nonparametric tests for non-normally distributed data.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 20, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2025

Completed
Last Updated

June 3, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

November 25, 2024

Last Update Submit

May 31, 2025

Conditions

Keywords

patient safetynewly graduated nursesSpeaking-Uptraining programtransition shockempowerment

Outcome Measures

Primary Outcomes (1)

  • Employee Voice Scale

    The Employee Voice Scale was developed by Van Dyne and LePine and is a 6-item, single-dimensional scale. In our country, the Employee Voice Scale was adapted to Turkish by Çetin and Çakmakçı. All items in the scale are measured on a 5-point Likert-type scale using the following scales: disagree, somewhat agree, partially agree, mostly agree, completely agree. Higher scores indicate more employee voice behavior.

    It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).

Secondary Outcomes (3)

  • Effective Communication Skills Scale

    It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).

  • Attitude Scale in Medical Errors

    It will be evaluated seven days before the intervention (pre-test) and seven days after the intervention (post-test).

  • Evaluation Form for the Speaking-Up Training Program

    It will be collected immediately after the intervention.

Study Arms (2)

SPEAKİNG UP TRAİNİNG GROUP

EXPERIMENTAL

A pre-test will be administered to all participants seven days before the training program begins. A language training program consisting of four modules will be given to the experimental group participants. The final test of the scales and the training program evaluation form will be administered to the experimental group participants seven days after the training program is completed.

Other: Speak up traning program

NON-TRAİNİNG GROUP

NO INTERVENTION

A pre-test will be applied to all participants seven days before the training program begins. No intervention will be made to the control group participants. The post-test of the scales will be applied to the control group again seven days after the training program of the experimental group participants is completed.

Interventions

The intervention includes the training program to be applied to the experimental group. The aims and objectives of the training program, the training content and modules were prepared by the researcher in line with the needs analysis. The training program consists of four modules: Communication, Speaking UP, Patient Safety and Medical Error. Before the training program starts, the training booklet will be distributed to the experimental group participants. In the training, teaching techniques such as plain narration, question and answer, brainstorming, case study, case discussion, station technique, six thinking hats technique, video-based error scenario activity etc. will be used. The video activity to be used in the speak up session of the training program was created by recording the correct and incorrect scenarios of three patient safety errors by experienced actors.

SPEAKİNG UP TRAİNİNG GROUP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having a maximum of two years of post-graduation professional experience
  • Having a minimum of three months of post-graduation professional experience
  • Being willing to participate in the research
  • Having completed general orientation training

You may not qualify if:

  • Having received previous training in language translation
  • Those with education below undergraduate level
  • Not having attended the entire training program
  • Not having completed all the data collection tools
  • Wanting to leave the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Nursing Faculty

Ankara, Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (10)

  • Akın, B. ve Koçoğlu, D. Randomize Kontrollü Deneyler. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi. 2017 4(1): 73-92.

    BACKGROUND
  • Van Dyne, L. ve LePine, J.A. (1998). Helping and voice extra-role behavior: Evidence of construct and predictive validity. Academy of Management Journal, 41, 108-119.

    BACKGROUND
  • Çetin, Ş. ve Çakmakçı, C. (2012). Çalışan Sesliliği Ölçeğini Türkçeye Uyarlama Çalışması. Kara Harp Okulu Bilim Dergisi, 22(2), 1.

    BACKGROUND
  • Güleç, D. ve İntepeler, Ş.S. (2013). Tıbbi hatalarda tutum ölçeğinin geliştirilmesi. Hemşirelikte Araştırma Geliştirme Dergisi, 15:3, 26-41.

    BACKGROUND
  • Buluş, M., Atan, A., & Sarıkaya, H. E. (2017). Effective Communication Skills: A New Concep-tual Framework and Scale Development Study. International Online Journal of Educational Sci-ences, 9(2).

    BACKGROUND
  • Lee SE, Kim E, Lee JY, Morse BL. Assertiveness educational interventions for nursing students and nurses: A systematic review. Nurse Educ Today. 2023 Jan;120:105655. doi: 10.1016/j.nedt.2022.105655. Epub 2022 Nov 25.

    PMID: 36462396BACKGROUND
  • Wawersik DM, Boutin ER Jr, Gore T, Palaganas JC. Individual Characteristics That Promote or Prevent Psychological Safety and Error Reporting in Healthcare: A Systematic Review. J Healthc Leadersh. 2023 Apr 17;15:59-70. doi: 10.2147/JHL.S369242. eCollection 2023.

    PMID: 37091553BACKGROUND
  • Lee SE, Choi J, Lee H, Sang S, Lee H, Hong HC. Factors Influencing Nurses' Willingness to Speak Up Regarding Patient Safety in East Asia: A Systematic Review. Risk Manag Healthc Policy. 2021 Mar 12;14:1053-1063. doi: 10.2147/RMHP.S297349. eCollection 2021.

    PMID: 33737846BACKGROUND
  • Lee E, De Gagne JC, Randall PS, Kim H, Tuttle B. Effectiveness of speak-up training programs for clinical nurses: A scoping review. Int J Nurs Stud. 2022 Dec;136:104375. doi: 10.1016/j.ijnurstu.2022.104375. Epub 2022 Oct 7.

    PMID: 36327680BACKGROUND
  • O'Donovan R, McAuliffe E. A systematic review exploring the content and outcomes of interventions to improve psychological safety, speaking up and voice behaviour. BMC Health Serv Res. 2020 Feb 10;20(1):101. doi: 10.1186/s12913-020-4931-2.

    PMID: 32041595BACKGROUND

MeSH Terms

Conditions

CommunicationEmpowerment

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Since the training will be provided by the researcher, blinding the researcher will not be possible. All participants in the intervention and control groups will think that they will receive the entire language training. It will be explained that the trainings will be planned on different dates, notifications will be sent to mobile phones regarding the start and end times of the trainings, and the nurse whose turn it is will be called to the training. In this way, blinding of the participant will be ensured. After the explanation, the same informed consent form will be signed by the intervention and control group nurses. The statistician will perform the statistical analyses without knowing which group is the intervention and which group is the control.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This research is a randomized, pretest-posttest control group, parallel group experimental study that will evaluate the effectiveness of the language training program developed for newly graduated nurses. An introductory information form and a pretest evaluation of the scales will be applied to the participants who accept to participate in the research seven days before the application. Then, the groups will be randomized by an expert other than the researcher and assigned to their groups. The language training program will be applied to the experimental group seven days after the pretest evaluations. No intervention will be made to the control group. The final evaluation of the scales will be made to both groups seven days after the experimental group participants complete the training program. The language training program evaluation form will also be applied to the experimental group participants and their opinions about the training program will be obtained.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nursing

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 2, 2024

Study Start

July 20, 2023

Primary Completion

March 24, 2025

Study Completion

June 24, 2025

Last Updated

June 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations