Stoma Education Methods and Nurse Learning Outcomes

NCT ID: NCT07061392

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2024-07-01

Brief Summary

The goal of this randomized controlled trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, improved meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels in oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. The main questions it aimed to answer were:

Did standardized-patient simulation produce greater gains in meaningful learning self-awareness?

Did it yield higher perceived learning scores?

Did it result in larger improvements in stoma-care skill levels?

Researchers compared Group M (standardized patient) to Group K (low-fidelity mannequin) to evaluate which method more effectively enhanced nurses' cognitive and technical outcomes.

Participants completed a 10-item demographic and background survey, answered pre-training assessments on all three scales, attended a two-hour didactic session on stoma fundamentals and evidence-based care, received two hours of hands-on practice with their assigned modality, and completed immediate post-training assessments using the same instruments.

Conditions

Stoma Care Knowledge and Skills of Nurses; Simulation Based Learning; Standardized Patient; Nurse; Self Awareness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Intervention Arm (Group M)

Participants in Group M (45 enrolled; 43 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics. They attended a two-hour didactic session on stoma indications, perioperative care, and evidence-based practices. Immediately after, each nurse engaged in a two-hour standardized-patient simulation using realistic stoma moulage. Simulations followed INACSL standards, including a 15-minute pre-briefing, \~20-minute individual in-scenario practice with cueing, peer observation, and a 15-20-minute PEARLS debriefing. All outcome measures were repeated immediately post-training to evaluate short-term cognitive and technical gains.

Group Type: EXPERIMENTAL

a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model

Intervention Type: OTHER

Control Arm (Group K) Participants randomized to Group K (n = 45 enrolled; 44 analyzed) underwent the identical sequence of baseline assessments and the same two-hour didactic session as Group M. For the practical component, they performed stoma-care simulation on a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model.

Hands-on practice was structured in small groups over two hours and included:

Pre-briefing: Overview of objectives and materials.

In-scenario: Individual stoma-care performance on the mannequin, guided by the certified stoma-care nurse with cueing as needed.

Observation: Peers observed from a separate area with scenario summaries.

Debriefing: Reflection and feedback using the PEARLS framework to consolidate learning and discuss transfer to clinical practice.

Immediate post-training assessments using the same three scales captured outcomes in meaningful learning self-awareness, perceived learning, and stoma-care skill level.

Control Arm (Group K)

Group K participants (n = 45 enrolled; 44 analyzed) completed baseline assessments of meaningful learning self-awareness, perceived learning, stoma-care skills, and demographics, and attended the same two-hour didactic session as Group M. They then performed a two-hour stoma-care simulation in small groups on a low-fidelity Prestan 2000 CPR mannequin fitted with a play-dough stoma model. Sessions followed INACSL structure: a brief pre-briefing of objectives and materials; individual mannequin practice with cueing; peer observation in an adjacent area; and a PEARLS-guided debriefing. Outcome measures were repeated immediately post-training to assess short-term cognitive and technical performance.

Group Type: EXPERIMENTAL

standardized-patient simulation

Intervention Type: OTHER

Intervention Arm (Group M) Participants randomized to Group M (n = 45 enrolled; 43 analyzed) first completed baseline assessments of meaningful learning self-awareness , perceived learning, and stoma-care skill , as well as a 10-item demographic survey. They then attended a two-hour didactic session-covering stoma indications, types, perioperative care, evidence-based practices, complications, and the stoma-care nurse's role-delivered by a certified stoma-care nurse in small groups.

Immediately following the lecture, each nurse participated in a two-hour hands-on simulation with a trained standardized patient. The standardized patient had been prepared with a realistic stoma moulage (transparent drape and egg-biscuit mixture) and received two hours of role-training. Simulation sessions adhered to INACSL Standards ("pre-briefing," "in-scenario," "observation," and "debrief

Interventions

standardized-patient simulation

Intervention Arm (Group M) Participants randomized to Group M (n = 45 enrolled; 43 analyzed) first completed baseline assessments of meaningful learning self-awareness , perceived learning, and stoma-care skill , as well as a 10-item demographic survey. They then attended a two-hour didactic session-covering stoma indications, types, perioperative care, evidence-based practices, complications, and the stoma-care nurse's role-delivered by a certified stoma-care nurse in small groups.

Immediately following the lecture, each nurse participated in a two-hour hands-on simulation with a trained standardized patient. The standardized patient had been prepared with a realistic stoma moulage (transparent drape and egg-biscuit mixture) and received two hours of role-training. Simulation sessions adhered to INACSL Standards ("pre-briefing," "in-scenario," "observation," and "debrief

Intervention Type: OTHER

a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model

Control Arm (Group K) Participants randomized to Group K (n = 45 enrolled; 44 analyzed) underwent the identical sequence of baseline assessments and the same two-hour didactic session as Group M. For the practical component, they performed stoma-care simulation on a low-fidelity Prestan 2000 adult CPR mannequin modified with a play-dough stoma model.

Hands-on practice was structured in small groups over two hours and included:

Pre-briefing: Overview of objectives and materials.

In-scenario: Individual stoma-care performance on the mannequin, guided by the certified stoma-care nurse with cueing as needed.

Observation: Peers observed from a separate area with scenario summaries.

Debriefing: Reflection and feedback using the PEARLS framework to consolidate learning and discuss transfer to clinical practice.

Immediate post-training assessments using the same three scales captured outcomes in meaningful learning self-awareness, perceived learning, and stoma-care skill level.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being a nursing graduate
• Working as a nurse in an oncology hospital for at least one year
• Working in inpatient units
• Actively providing care to patients with ostomies

Exclusion Criteria

• Holding a managerial position
• Having taken a course or received certification on stoma care within the last six months
• Being pregnant, on unpaid leave, or on sick leave
• Participating in another study during the same period
• Incomplete completion of the data collection form
• Voluntary withdrawal from the study during the research period

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Merve BEKE

Educator Nurse, MsC, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merve Beke, MsC

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024-KAEK-07

Identifier Type: -

Identifier Source: org_study_id