Core CompetencyNCT07527429
Procedure Manual-Based Simulation Training to Improve Operating Room Nurses' Core Competencies
A study testing Procedure Manual-Based Simulation Training in people with Core Competency and Patient Safety, run by Hiroshima University at 1 site in Cambodia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Core Competency, Patient Safety, Interprofessional Collaboration
- What is being tested?
- Procedure Manual-Based Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCambodia
- Study dates
- 20 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Cambodia1 site
Cambodia-China Friendship Preah Kossamak Hospital
Phnom Penh, Phnom Penh, 170000
About this study
Official title: 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.
Read the 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.
- Conditions
- Core Competency, Patient Safety, Interprofessional Collaboration, Surgical Outcome, Job Satisfaction
- Being tested
- Procedure Manual-Based Simulation Training
- Keywords
- Simulation Training, Procedure Manual, Operating Room Nurses, Cambodia, Quasi-Experimental Study, Nursing Education, Interprofessional Collaboration, Surgical Outcomes, Job Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure Manual-Based Simulation TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Simulation Training Group | Experimental | 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. Receives: Behavioral: Procedure Manual-Based Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Competencies of Operating Room (OR) Nurses
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.
Measured: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
Secondary outcomes (3)
Interprofessional Collaboration
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.
Measured: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
Job Satisfaction
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.
Measured: Baseline (Day 0) and End-line (8 weeks), immediately following the 2-week training and 6-week implementation phase.
Surgical Outcome
Mean duration of the total time from "skin incision" to "skin closure" for the targeted procedures (Total Hip Replacement and Retrograde Intrarenal Surgery).
Measured: Comparison of the 1 month prior to intervention (baseline) versus 1 month after the total intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start20 Apr 2026
- Primary completion20 Jul 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Core CompetencyStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a quasi-experimental, single-group study utilizing a pre- and post-test design. All enrolled participants undergo the same sequence of events: baseline data collection, followed by a two-week standardized training intervention (lectures and simulations). After the training, participants enter a six-week clinical implementation phase to apply the procedure manual in real surgical settings. Finally, end-line data is collected to evaluate changes in core competencies and secondary outcomes.
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEN Leang E, Hiroshima University
- Investigators
- Michiko Moriyama, RN, MSN, Ph.D, FAAN, Study director, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527429
- Sponsor's protocol ID
- Version 1.0-28/01/2026
- Other IDs
- NECHR-2026-175
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly to maintain the confidentiality and privacy of the operating room nurses involved in the study, as required by the National Ethics Committee for Health Research (NECHR) in Cambodia. Results will be disseminated through a Master's thesis and peer-reviewed publications using aggregated data only.
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
Gillespie BM, Polit DF, Hamlin L, Chaboyer W. Developing a model of competence in the operating theatre: psychometric validation of the perceived perioperative competence scale-revised. Int J Nurs Stud. 2012 Jan;49(1):90-101. doi: 10.1016/j.ijnurstu.2011.08.001. Epub 2011 Aug 30.
PubMed 21880313Gittell 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.
PubMed 10929993
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Procedure Manual-Based Simulation Training on Operating Room Nurses' Core Competencies in a Cambodian National Hospital: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07527429
- Acronym / sponsor ID
- Version 1.0-28/01/2026
- Conditions
- Core Competency, Patient Safety, Interprofessional Collaboration, Surgical Outcome, Job Satisfaction
- Keywords
- Simulation Training, Procedure Manual, Operating Room Nurses, Cambodia, Quasi-Experimental Study, Nursing Education, Interprofessional Collaboration, Surgical Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Apr 2026 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a quasi-experimental, single-group study utilizing a pre- and post-test design. All enrolled participants undergo the same sequence of events: baseline data collection, followed by a two-week standardized training intervention (lectures and simulations). After the training, participants enter a six-week clinical implementation phase to apply the procedure manual in real surgical settings. Finally, end-line data is collected to evaluate changes in core competencies and secondary outcomes.
| Arm | Type | Receives |
|---|---|---|
| Simulation Training Group | Experimental | Behavioral: Procedure Manual-Based Simulation TrainingRegistered 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Procedure Manual-Based Simulation TrainingThe 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. | Behavioural | Simulation Training Group |
Primary outcome
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.
3 secondary outcomes
Interprofessional Collaboration
Time frame: 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.
Surgical Outcome
Time frame: Comparison of the 1 month prior to intervention (baseline) versus 1 month after the total intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Results publicationBrayfield, A. H., & Rothe, H. F. (1951). An Index of Job Satisfaction. Journal of Applied Psychology, 35, 307-311. https://doi.org/10.1037/h0055617
- Results publication: PubMed 21880313Gillespie BM, Polit DF, Hamlin L, Chaboyer W. Developing a model of competence in the operating theatre: psychometric validation of the perceived perioperative competence scale-revised. Int J Nurs Stud. 2012 Jan;49(1):90-101. doi: 10.1016/j.ijnurstu.2011.08.001. Epub 2011 Aug 30.
- Results publication: PubMed 10929993Gittell 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.
- Hiroshima University - Graduate School of Biomedical and Health SciencesLink provided by the sponsor.
- Cambodia-China Friendship Preah Kossamak Hospital (CCFKH)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to maintain the confidentiality and privacy of the operating room nurses involved in the study, as required by the National Ethics Committee for Health Research (NECHR) in Cambodia. Results will be disseminated through a Master's thesis and peer-reviewed publications using aggregated data only.
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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.
Michiko Moriyama, RN, MSN, Ph.D, FAAN study director
Hiroshima 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 Procedure Manual-Based Simulation Training in people with Core Competency and Patient Safety, run by Hiroshima University at 1 site in Cambodia.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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 Cambodia. 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?
This study is still under way. Results are not available in the source record yet.
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?
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.). 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 NCT07527429, which also lists 3 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 8 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.