- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07527429
Procedure Manual-Based Simulation Training to Improve Operating Room Nurses' Core Competencies
The Impact of Procedure Manual-Based Simulation Training on Operating Room Nurses' Core Competencies in a Cambodian National Hospital: A Quasi-Experimental Study
This study aims to evaluate the effectiveness of a procedure manual-based simulation training program in improving the core competencies of operating room nurses in a Cambodian national hospital. Operating room nurses play a critical role in maintaining patient safety, assisting the surgical team, and ensuring efficient surgical workflow.
This study will use a single-group quasi-experimental pre-post design. Baseline data will be collected before the intervention to assess operating room nurses' core competencies, interprofessional collaboration, job satisfaction, and surgical procedure duration.
Participants will receive structured educational sessions and simulation-based training based on standardized surgical procedure manuals. After the training phase, nurses will implement the procedure manuals during real surgical procedures for six weeks. End-line data will be collected to evaluate improvements in competency levels, teamwork, job satisfaction, and surgical efficiency.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- Background and Rationale Nurses in Cambodia face significant challenges in achieving the government's goal of Universal Health Coverage, specifically regarding the quality of care and competency levels. This study addresses the need for standardized procedure manuals in the operating room (OR) to minimize practice variation, reduce adverse outcomes, and enhance the core competencies of OR nurses at the Cambodia-China Friendship Preah Kossamak Hospital (CCFKH).
- Study Design This is a quasi-experimental study utilizing a one-group pre- and post-test design. There is no control group or randomization involved. The study aims to recruit approximately 49 registered nurses currently working in the intraoperative phase at CCFKH.
- Intervention Protocol
The intervention is divided into three distinct phases:
- Preparation: Standardized surgical procedure manuals and training videos were developed for two specific procedures: Total Hip Replacement (THR) in orthopedics and Retrograde Intrarenal Surgery (RIRS) in urology.
- Training Phase (2 weeks): Participants are divided into six small groups of approximately eight members. Each group attends two sessions biweekly. Each session consists of a 1-hour lecture and 2 hours of simulation practice. An E-manual is provided for continuous self-study.
Implementation Phase (6 weeks): Following training, participants implement the standardized protocols during real surgical procedures. During this time, the research team provides follow-up support and consultation to address clinical concerns.
- Data Collection and Outcomes
Data will be collected at baseline (pre-intervention) and after the intervention period (end-line) with primary outcome and secondary outcomes:
- Primary Outcome: Core competency is measured using a 20-item researcher-developed questionnaire based on a 5-point Likert scale (total score range: 20-100).
Secondary Outcomes: These include Interprofessional Collaboration (Relational Coordination Survey), Job Satisfaction (Short Index of Job Satisfaction), and Surgical Outcome (measured as procedure duration/surgical time).
- Analysis Statistical evaluation will include descriptive statistics and paired t-tests to analyze changes between baseline and end-line data.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: LEANG E LEN, RN, BSN, Master Student
- Phone Number: +85598735350
- Email: leangent13@gmail.com
Study Contact Backup
- Name: Michiko Moriyama, RN, MSN, Ph.D, FAAN
- Phone Number: +81-82-257-5365
- Email: morimich@hiroshima-u.ac.jp
Study Locations
-
-
Phnom Penh
-
Phnom Penh, Phnom Penh, Cambodia, 170000
- Cambodia-China Friendship Preah Kossamak Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered nurses who are appointed to work in the intraoperative phase of Cambodia-China Friendship Preah Kossamak Hospital.
- Registered nurses at Cambodia-China Friendship Preah Kossamak Hospital who are willing to participate in the study.
Exclusion Criteria:
- Registered Nurses Cambodia-China Friendship Preah Kossamak Hospital who are unable to participate in intervention requirements.
- Registered Nurses Cambodia-China Friendship Preah Kossamak Hospital who are scheduled to participate in hospital mission assignments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simulation Training Group
Registered Operating Room (OR) nurses at the Cambodia-China Friendship Preah Kossamak Hospital (CCFKH) who participate in a standardized procedure manual-based simulation training program.
This group undergoes a two-week training phase followed by a six-week clinical implementation phase.
|
The intervention consists of a simulation training program of procedure manuals focused on two surgical procedures: Total Hip Replacement (THR) and Retrograde Intrarenal Surgery (RIRS). Training Phase (2 weeks): Participants attend two sessions (one per procedure). Each session includes a 1-hour lecture and 2 hours of hands-on simulation practice. Self-Study: Participants are provided with a digital E-manual for continuous review. Implementation Phase (6 weeks): Participants apply the standardized procedure manuals in real surgical settings with follow-up support from the research team. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Core Competencies of Operating Room (OR) Nurses
Time Frame: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
Measured using a 20-item researcher-developed intraoperative core competency scale.
It uses a five-point Likert scale (1: never to 5: always).
The total score ranges from 20 to 100, where a higher score indicates a higher level of nursing competency in the operating room.
|
Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interprofessional Collaboration
Time Frame: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
Measured by the Relational Coordination Survey (RCS).
This 7-item tool uses a five-point Likert scale.
The total score ranges from 7 to 35, where a higher score represents better collaboration between surgeons, anesthetists, and nurses.
|
Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
|
Job Satisfaction
Time Frame: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
Measured by the Short Index of Job Satisfaction (SIJS).
This 5-item tool uses a five-point Likert scale.
The total score ranges from 5 to 25, where a higher score indicates greater job satisfaction among OR nurses.
|
Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
|
|
Surgical Outcome
Time Frame: Comparison of the 1 month prior to intervention (baseline) versus 1 month after the total intervention period.
|
Mean duration of the total time from "skin incision" to "skin closure" for the targeted procedures (Total Hip Replacement and Retrograde Intrarenal Surgery).
|
Comparison of the 1 month prior to intervention (baseline) versus 1 month after the total intervention period.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Michiko Moriyama, RN, MSN, Ph.D, FAAN, Hiroshima University
Publications and helpful links
General Publications
- Brayfield, A. H., & Rothe, H. F. (1951). An Index of Job Satisfaction. Journal of Applied Psychology, 35, 307-311. https://doi.org/10.1037/h0055617
- 15. Gillespie, B. M., Polit, D. F., Hamlin, L., & Chaboyer, W. (2012). Developing a model of competence in the operating theatre: psychometric validation of the perceived perioperative competence scale-revised. International journal of nursing studies, 49(1), 90-101. https://doi.org/10.1016/j.ijnurstu.2011.08.001
- Gittell JH, Fairfield KM, Bierbaum B, Head W, Jackson R, Kelly M, Laskin R, Lipson S, Siliski J, Thornhill T, Zuckerman J. Impact of relational coordination on quality of care, postoperative pain and functioning, and length of stay: a nine-hospital study of surgical patients. Med Care. 2000 Aug;38(8):807-19. doi: 10.1097/00005650-200008000-00005.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Version 1.0-28/01/2026
- NECHR-2026-175 (Other Identifier: National Ethics Committee for Health Research (NECHR), Cambodia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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