ISRCTN ISRCTN70194768
DOI https://doi.org/10.1186/ISRCTN70194768
Sponsor Lianyungang Clinical College, Xuzhou Medical University
Funder Xuzhou Medical University
Submission date
27/03/2026
Registration date
02/04/2026
Last edited
30/03/2026
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Mr Chong Gao
Public, Scientific, Principal investigator

Lianyungang Clinical College, Xuzhou Medical University, No.41 Hailiandong Road, Haizhou District
Lianyungang
222006
China

Phone +86 15961372969
Email 448215636@qq.com

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlPlacebo
AssignmentParallel
PurposeTo evaluate whether 3D Printing combined with mind-mapping improve knowledge, skills and engagement among nursing interns in orthopedic nursing education.
Scientific title3D printing and mind mapping in clinical orthopedic nursing education: a comparative randomized controlled trial
Study objectives To evaluate whether 3D Printing combined with mind-mapping improve knowledge, skills and engagement among nursing interns in orthopedic nursing education.
Ethics approval(s)Ethics approval not required
Health condition(s) or problem(s) studiedEligible participants were third-year nursing students
Intervention• Randomisation procedure: Participants were randomly allocated (1:1) to either the control group (CG) or observation group (OG) using R software (version 4.3.1). The sample function generated a simple random allocation sequence with the random seed set to 12345 for reproducibility.
• Allocation concealment: The allocation results were printed and sealed in sequentially numbered, opaque, tamper-evident envelopes, stored in a locked cabinet. On the first day of placement, a dedicated secretary opened the next envelope in sequence to reveal group assignment; instructors remained blinded until the envelope was opened.
• Control group (CG): Received traditional orthopedic nursing teaching using PowerPoint slides, X-rays, and plastic models (20 hours over 4 weeks).
• Intervention group (OG): Received the same contact hours (20 hours over 4 weeks) enhanced with 3D printed pelvic fracture models and mind mapping (instructor-constructed and student-generated maps using X-Mind 8.0).

The observation group followed an identical schedule to the control group with equivalent total teaching time of 4 weeks and 5 contact hours per week, supplemented with three additional components. First, instructor-constructed mind maps were created using X-Mind 8.0 centred on "pelvic fracture nursing" with branches covering etiology, classification, peri-operative care and complication prevention. Second, a 1:1 scale 3D printed model of a pelvic fracture was employed to facilitate in-depth exploration of injury mechanisms, diagnostic comparisons, and the nuances of nursing care, with interactive discussions fostered among interns and the 3D model circulated to enhance learning through multiple sensory modalities. Third, student-generated mind maps were introduced from week 2, where small groups created individual maps, presented them, and revised after peer and instructor feedback, encouraging interns to construct their own mind maps aligned with educational objectives while critically analyzing variances relative to the instructor's version to bolster self-directed learning and critical thinking competencies.

A baseline theoretical assessment (T0) was conducted one day before placement commencement. Upon completion of the 4-week intervention, participants underwent both theoretical and practical assessments (T1), followed immediately by the teaching effectiveness questionnaire (T2). All assessments were administered by evaluators blinded to group allocation.

The Teaching Effectiveness Evaluation Questionnaire is a structured evaluation instrument designed to assess teaching competency specifically within the domain of orthopedic nursing education. The form employed a multi-dimensional approach, evaluating competencies across five core dimensions critical to effective orthopedic nursing instruction and practice. Learning Interest assessed the learner's engagement through active participation in orthopedic case discussions, awareness of advancements in postoperative rehabilitation, and initiative in exploring specialized literature. at Baseline theoretical assessment (T0) was conducted one day before placement commencement. Upon completion of the 4-week intervention, participants underwent both theoretical and practical assessments (T1), followed immediately by the teaching effectiveness questionnaire (T2).
Intervention typeOther
Primary outcome measure(s)
  1. Nursing knowledge competency measured using the Theoretical Assessment (100-point comprehensive examination covering etiology, pathology, clinical decision-making, and case analysis) at baseline (T0, one day before placement) and at the end of the 4-week intervention (T1)
  2. Clinical practical skills measured using the Practical Skills Assessment (structured OSCE-style evaluation based on hospital's "Clinical Nursing Technical Operation Procedures and Standards for 2019," covering preparation, key assessments, procedures, and evaluation) at the end of the 4-week intervention (T1)
Key secondary outcome measure(s)
  1. Teaching effectiveness and student competencies measured using the Teaching Effectiveness Evaluation Questionnaire (15-item, 3-point Likert scale assessing five dimensions: Learning Interest, Clinical Cognitive Abilities, Self-Learning Abilities, Communication and Collaboration Skills, and Summarization/Synthesis Abilities; see Supplementary Material 3) at the end of the 4-week intervention (T2, administered on the same day as T1, within 24 hours after course completion)
Completion date31/12/2023

Eligibility

Participant type(s)
Age groupAdult
Lower age limit18 Years
Upper age limit35 Years
SexAll
Target sample size at registration60
Total final enrolment60
Key inclusion criteria1. Third-year nursing students undertaking their first orthopaedic placement
2. No prior training in 3-D printing or mind-mapping
3. Provided voluntary written informed consent
Key exclusion criteria1. Absences exceeding 3 consecutive days or 5 cumulative days during the placement
2. Had previously participated in similar thinking-skills courses
3. Colour-vision or cognitive impairment preventing graphical learning
Date of first enrolment01/08/2019
Date of final enrolment31/08/2023

Locations

Countries of recruitment

  • China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other files 30/03/2026 No No
Other files 30/03/2026 No No
Other files 30/03/2026 No No

Additional files

49280_Supplementary Material 1_Theoretical Assessment details.pdf
Other files
49280_Supplementary material 2_Practical Skills Assessment criteria.pdf
Other files
49280_Supplementary material 3_Teaching Effectiveness Evaluation Questionnaire.pdf
Other files

Editorial Notes

30/03/2026: Study’s existence confirmed by the Academic Affairs Office of Xuzhou Medical University, China.