Stoma Education Methods and Nurse Learning Outcomes

NCT07061392 | Completed DMC

• 1 other identifier: 2024-KAEK-07
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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

Keywords

stoma; nurses; self awarness; meaningful learning; clinical simulation; standardized patients; low reality model

Outcome Measures

Primary Outcomes (1)

• practical stoma-care competence

  1. Meaningful Learning Self-Awareness Change in total and subscale scores on the 24-item Meaningful Learning Self-Awareness Scale, assessed before and immediately after training. The scale was administered as a self-report questionnaire. Higher post-training scores indicate increased awareness of metacognitive strategies and more effective transfer of learning. 2. Perceived Learning Change in total and factor scores on the 9-item Perceived Learning Scale, administered before and immediately after training. The scale measures self-perceived learning in cognitive, emotional, and psychomotor domains. Higher post-training scores reflect increased perceived learning gains. 3. Stoma-Care Skill Proficiency Description: Change in total scores on the 23-item Stoma Care Skill Rubric, based on direct observation before and immediately after training during simulated stoma-care performance. Higher post-training scores indicate improved technical competence in ostomy care.

  At baseline and immediately after training

Study Arms (2)

Intervention Arm (Group M)

EXPERIMENTAL

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.

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

Control Arm (Group K)

EXPERIMENTAL

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.

Other: standardized-patient simulation

Interventions

standardized-patient simulation 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

Control Arm (Group K)

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

Intervention Arm (Group M)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Study Officials

• Merve Beke, MsC

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In this trial, the educators who delivered the interventions, the research staff who collected the data, and the investigators who performed the analyses were all aware of participants' group assignments. Only the independent outcome assessor remained blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Educator Nurse, MsC, PhD

Model Details: The goal of this randomized, parallel-group, assessor-blinded interventional trial was to determine whether stoma-care training using standardized patients, as compared with low-fidelity mannequins, produced superior gains in meaningful learning self-awareness, perceived learning, and practical stoma-care skill levels among oncology nurses at a 600-bed tertiary oncology education and research hospital in Ankara, Turkey. Key features of the interventional study model included: Design: Two-arm, parallel assignment, assessor-blinded randomized controlled trial. Randomization: Ninety nurses were allocated 1:1 to Group M (standardized patient) or Group K (low-fidelity mannequin) using simple block randomization with allocation concealment via sealed envelopes matched to a password-protected Excel list. Sample size and flow: Based on G\*Power analysis (effect size = 0.6, α = 0.05, β = 0.20), a minimum of 42 nurses per group was required; 45 were enrolled in each arm. After excluding those

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: April 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

TU (1)