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Completed

NCT Number: NCT07061392

Stoma Education Methods and Nurse Learning Outcomes

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, 06560, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. practical stoma-care competence

    Time frame: At baseline and immediately after training

    • 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.
    • 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.
    • 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effect of Stoma Education Given to Nurses With Two Different Methods on Their Meaningful Learning Self-Awareness, Perceived Learning and Stoma Care Skill Levels: A Randomized Controlled Experimental Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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