- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552363
ChatGPT-Driven Blended Teaching for Pain Management in Nursing Students: A Randomized Controlled Trial
Effect of a ChatGPT-Driven Blended Teaching Model for Pain Management on Knowledge, Attitudes, Competence, and Self-Efficacy Among Nursing Students: A Two-Arm Parallel-Group Randomized Controlled Trial
Pain management is a core competency in nursing practice, yet nursing students consistently demonstrate insufficient knowledge, unfavorable attitudes, limited competence, and low self-efficacy in this area. Artificial intelligence (AI)-based educational tools, particularly ChatGPT, have emerged as promising resources in nursing education; however, rigorous experimental evidence on their effectiveness remains scarce.
This study is a two-arm, parallel-group randomized controlled trial (RCT) that aims to evaluate the effect of a ChatGPT-driven blended teaching model for pain management on nursing students' knowledge and attitudes toward pain, nursing competence, and learning self-efficacy.
Eligible nursing students at Shahid Beheshti University of Medical Sciences (Tehran, Iran) will be randomly assigned in a 1:1 ratio to either:
- Intervention group: ChatGPT-assisted blended clinical nursing rounds (8 sessions over 4 weeks, each 90 minutes, combining bedside rounds with AI-assisted pre- and post-round activities)
- Control group: Traditional clinical nursing rounds (same number and duration of sessions, without any AI tools)
Outcomes will be measured at baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up using validated instruments: the Nurses' Knowledge and Attitudes Survey Regarding Pain (NKASRP), the Nursing Student Competence Scale (NSCS), and the Nursing Students' Learning Self-Efficacy instrument (NLSE).
Findings will provide empirical evidence to guide educational policy and curriculum design in nursing programs, with the goal of improving pain management education and patient care outcomes.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sogand Sarmadi
- Phone Number: +989198599908
- Email: sogand.sarmadi@ymail.com
Study Locations
-
-
Tehran Province
-
Tehran, Tehran Province, Iran
- Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
-
Contact:
- Sogand Sarmadi
- Phone Number: +989198599908
- Email: sogand.sarmadi@ymail.com
-
Principal Investigator:
- sogand sarmadi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate nursing students in their fourth semester or higher, or master's or doctoral nursing students engaged in clinical training involving direct patient care
- Provision of electronic informed consent
- Access to the internet and a personal device (computer, tablet, or smartphone) for the asynchronous components of the blended teaching model
- No participation in a formal comprehensive pain management course within the previous 12 months
Exclusion Criteria:
- Inability to attend at least one face-to-face session or to complete online activities (e.g., due to repeated absences)
- Any self-reported or university-documented cognitive or mental health condition that prevented completion of questionnaires or participation in training
- Voluntary withdrawal at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ChatGPT-Driven Blended Teaching Group
Participants receive a blended teaching intervention integrating ChatGPT-assisted instruction with traditional in-person clinical nursing rounds focused on pain management.
The intervention consists of 8 sessions over 4 weeks (2 sessions per week), each approximately 90 minutes, comprising three phases: pre-round preparation (30 min) using standardized ChatGPT prompts and case-based learning; bedside nursing round (30 min) with patient assessment and instructor feedback; and post-round activities (30 min) using ChatGPT to resolve uncertainties and complete case reports.
Students are organized in groups of 4-6 and rotate through medical, surgical, and chronic pain clinical departments.
|
A blended teaching model integrating ChatGPT with in-person clinical nursing rounds for pain management education.
Delivered over 4 weeks (8 sessions × 90 minutes).
Each session includes: (1) pre-round preparation using standardized ChatGPT prompts for case analysis and evidence retrieval; (2) bedside nursing rounds with pain assessment, patient education, and instructor feedback; and (3) post-round activities using ChatGPT to resolve clinical uncertainties and complete case reports.
All ChatGPT outputs were reviewed by supervising faculty for accuracy.
Students used pre-designed, standardized prompts based on the WHO analgesic ladder and national clinical protocols.
Other Names:
|
|
Active Comparator: Traditional Clinical Nursing Rounds Group
Participants receive traditional clinical nursing rounds without any ChatGPT or AI components.
The instructor selects and introduces clinical cases; students review resources and prepare reports.
During rounds, the instructor directs all activities, including case presentation, assessment, nursing diagnosis, intervention, and outcome evaluation.
The control group receives an identical number and duration of sessions (8 sessions over 4 weeks, each approximately 90 minutes) in the same clinical departments to ensure exposure consistency.
|
Standard clinical nursing rounds without AI tools.
The instructor directs all activities including case introduction, bedside assessment, nursing diagnosis, intervention planning, and outcome evaluation.
Students primarily observe and respond to instructor questions.
Sessions match the intervention group in number, duration, and clinical setting (8 sessions × 90 minutes over 4 weeks).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge and Attitudes Toward Pain
Time Frame: Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
Measured using the Nurses' Knowledge and Attitudes Survey Regarding Pain (NKASRP), a 39-item instrument comprising 22 true/false questions, 13 multiple-choice questions, and 2 case studies.
Each correct answer scores 1 point (range: 0-39); results expressed as percentage of correct responses.
Higher scores indicate better knowledge and attitudes toward pain management.
A Persian forward-backward translation was performed, with face and content validity confirmed by a nursing faculty panel.
|
Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nursing Competence
Time Frame: Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
Measured using the Persian version of the Nursing Student Competence Scale (NSCS), a 28-item instrument across 6 subscales: medical-related knowledge, basic nursing skills, communication and cooperation, lifelong learning, global perspective, and critical thinking.
Items rated on a 5-point Likert scale (range: 28-140).
Higher scores indicate greater competence.
The Persian version demonstrated Cronbach's α = 0.90 and ICC = 0.88.
|
Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
|
Learning Self-Efficacy
Time Frame: Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
Measured using the Persian version of the Nursing Students' Learning Self-Efficacy instrument (NLSE), a 21-item instrument across 5 dimensions: conceptual understanding, higher-order cognitive skills, practical work, everyday application, and nursing communication.
Items rated on a 5-point Likert scale (range: 21-105).
Higher scores indicate greater self-efficacy.
The Persian version demonstrated Cronbach's α = 0.93 and ICC = 0.89.
|
Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.SBMU.PHARMACY.REC.1405.046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain Management
-
Yeditepe University HospitalCompletedPain Management | Breast Augmentation | Pain Management After Surgery | Pain Management in Postoperative CareTurkey
-
Kutahya Health Sciences UniversityBartın Unıversity; Mardin Artuklu UniversityCompletedPain Management | Nonpharmalogical Pain Management | Children Pain ManagementTurkey
-
Assiut UniversityNot yet recruitingPain Management | Neonates Pain Management
-
Misr University for Science and TechnologyActive, not recruitingPain | Pain Management | Pain Management in Postoperative CareEgypt
-
Wolfson Medical CenterUnknownPain Management | Post Surgical Management | Inflamation ManagementIsrael
-
Värmland County Council, SwedenSykehuset Telemark; Örebro University, Sweden; Dalarna County Council, Sweden; Region... and other collaboratorsCompletedInfant Pain Management | Parent-driven Pain ManagementSweden
-
Sintetica SACross S.A.CompletedPhase 1: Pain Management | Phase 2: Pain ManagementSwitzerland
-
University of California, Los AngelesNot yet recruitingPostoperative Pain Management
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Pain ManagementTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompleted
Clinical Trials on ChatGPT-Driven Blended Teaching Model for Pain Management
-
Hengxu WangNot yet recruitingGenerative Artificial Intelligence
-
Jordan Miller, PT, PhDUniversity Hospitals Kingston Foundation - Women's Giving CircleCompleted
-
National Taipei University of Nursing and Health...Recruiting