UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062895 |
|---|---|
| Receipt number | R000072015 |
| Scientific Title | Integrating Pendleton's Feedback with Peyton's Four-Step Approach to Enhance Clinical Skill Acquisition and Retention among Undergraduate Medical Students: A Randomized Controlled Educational Trial |
| Date of disclosure of the study information | 2026/09/12 |
| Last modified on | 2026/09/12 14:56:44 |
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Basic information
Public title
Integrating Pendleton's Feedback with Peyton's Four-Step Approach to Enhance Clinical Skill Acquisition and Retention among Undergraduate Medical Students: A Randomized Controlled Educational Trial
Acronym
Integrating Pendleton's Feedback with Peyton's Four-Step Approach to Enhance Clinical Skill Acquisition and Retention among Undergraduate Medical Students: A Randomized Controlled Educational Trial
Scientific Title
Integrating Pendleton's Feedback with Peyton's Four-Step Approach to Enhance Clinical Skill Acquisition and Retention among Undergraduate Medical Students: A Randomized Controlled Educational Trial
Scientific Title:Acronym
Integrating Pendleton's Feedback with Peyton's Four-Step Approach to Enhance Clinical Skill Acquisition and Retention among Undergraduate Medical Students: A Randomized Controlled Educational Trial
Region
| Asia(except Japan) |
Condition
Condition
Undergraduate Medical Education (Clinical Skills Training)
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective:
> To compare the effectiveness of Peyton's Four-Step Approach alone versus Peyton's Four-Step Approach integrated with Pendleton's structured feedback in improving immediate clinical skill performance in intravenous cannulation among undergraduate medical students.
Secondary objectives:
> To compare four-week skill retention, learner confidence, student satisfaction, motivation for learning, and faculty perceptions between the two teaching methods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
> Objective Structured Clinical Examination (OSCE) score for intravenous cannulation measured using a standardized 20-point checklist.
Time point:
> Immediately after completion of the teaching intervention (Day 0).
Key secondary outcomes
### Secondary outcomes
1. OSCE score (skill retention) measured using the same 20-point checklist 4 weeks after the intervention.
2. Student confidence in performing intravenous cannulation measured using a 5-point Likert scale immediately after the intervention.
3. Student satisfaction with the teaching method measured using a validated 5-point Likert questionnaire immediately after the intervention.
4. Learning motivation measured using a 5-point Likert scale immediately after the intervention.
5. Faculty perception of acceptability, feasibility, and appropriateness measured using a structured questionnaire at completion of the teaching sessions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
### Intervention Group (Experimental)-
Name: Peyton + Pendleton Group
Description:
> Students received intravenous cannulation training using Peyton's Four-Step Approach followed immediately by structured feedback based on Pendleton's feedback model. The feedback included learner self-reflection, reinforcement of strengths, identification of areas for improvement, and faculty-guided constructive feedback.
Interventions/Control_2
### Control Group
Name: Peyton Group
Description:
> Students received intravenous cannulation training using Peyton's Four-Step Approach alone, including demonstration, deconstruction, comprehension, and supervised performance, without structured Pendleton feedback.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Phase three MBBS undergraduate medical students enrolled at North DMC Medical College, Delhi, india.
-Aged eighteen to thirty years.
-Willing to participate and provided written informed consent.
-Available for immediate and four-week follow-up assessment.
Key exclusion criteria
1.Previous formal training or certification in intravenous cannulation.
2.Declined participation or did not provide informed consent.
3.Absent during the intervention or outcome assessment sessions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Anshumali |
| Middle name | |
| Last name | Gupta |
Organization
North DMC Medical College & Hindu Rao Hospital
Division name
North DMC Medical College & Hindu Rao Hospital
Zip code
110007
Address
Hindu Rao Hospital, Malka Ganj ,delhi
TEL
919910036422
doc.anshu.gupta@gmail.com
Public contact
Name of contact person
| 1st name | Siddharth |
| Middle name | |
| Last name | Sekhri |
Organization
North DMC Medical College & Hindu Rao Hospital
Division name
North DMC Medical College & Hindu Rao Hospital
Zip code
110007
Address
Hindu Rao Hospital, Malka Ganj ,delhi
TEL
918527371412
Homepage URL
siddharthsekhri1010@gmail.com
Sponsor or person
Institute
North DMC Medical College & Hindu Rao Hospital
Institute
Department
Personal name
Funding Source
Organization
North DMC Medical College & Hindu Rao Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
North DMC Medical College & Hindu Rao Hospital
Address
Hindu Rao Hospital, Malka Ganj ,delhi
Tel
919868960145
deanndmcmc@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 12 | Day |
Last modified on
| 2026 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072015
