NCT07552363

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

ChatGPTArtificial IntelligenceBlended LearningPain ManagementNursing StudentsClinical CompetenceRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Knowledge and Attitudes Toward Pain

    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 Outcomes (2)

  • Nursing Competence

    Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up

  • Learning Self-Efficacy

    Baseline (1 week before intervention), immediate post-test (1 week after intervention), and 3-month follow-up

Study Arms (2)

ChatGPT-Driven Blended Teaching Group

EXPERIMENTAL

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.

Behavioral: ChatGPT-Driven Blended Teaching Model for Pain Management

Traditional Clinical Nursing Rounds Group

ACTIVE COMPARATOR

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.

Behavioral: Traditional Clinical Nursing Rounds

Interventions

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.

Also known as: AI-Assisted Blended Clinical Nursing Rounds
ChatGPT-Driven Blended Teaching Group

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).

Traditional Clinical Nursing Rounds Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

AgnosiaBehavior

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the educational intervention, blinding of participants and instructors was not feasible. Outcome assessors responsible for administering and scoring questionnaires, and the data analyst, remained blinded to group allocation throughout the study. All questionnaires were distributed using participant identification codes rather than names.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two-arm parallel-group design with 1:1 allocation ratio. Participants are randomly assigned to either a ChatGPT-driven blended teaching group or a traditional clinical nursing rounds group. Both groups receive the same number and duration of sessions (8 sessions over 4 weeks, each approximately 90 minutes) in the same clinical departments.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shahid Beheshti University of Medical Sciences

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations