Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:13 PM
Study NCT ID:
NCT07404020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-11
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AI-Powered OSCE Coaching in Improving Infertility Counseling Skills in Nursing Students
Sponsor:
Sakarya University
Organization:
Study Overview
Official Title:
AI-Powered OSCE Coaching in Improving Infertility Counseling Skills: A Randomized Controlled Study in Nursing Students
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AI-OSCE-Infert
Brief Summary:
This randomized controlled experimental study aims to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted with undergraduate nursing students at Bartın University Faculty of Health Sciences and follows a two-group pretest-posttest design.
A total of 96 students will be randomly assigned to either the intervention group or the control group using computer-generated randomization. The intervention group will participate in an AI-powered OSCE coaching simulation consisting of 6-8 infertility counseling micro-scenarios, incorporating structured feedback and deliberate practice cycles. The control group will receive conventional infertility counseling education using standard teaching methods.
Outcomes will be assessed using the Therapeutic Communication Skills Scale for Nursing Students, the Jefferson Scale of Empathy for Nursing Students, and a rubric-based infertility counseling communication performance assessment based on the Kalamazoo Consensus Statement. Performance evaluations will be conducted via standardized virtual patient interviews and scored by two blinded independent raters.
Data will be analyzed using ANCOVA to assess intervention effects while controlling for baseline scores. This study aims to contribute evidence on the effectiveness of AI-supported OSCE coaching in enhancing communication and empathy skills in nursing education.
A total of 96 students will be randomly assigned to either the intervention group or the control group using computer-generated randomization. The intervention group will participate in an AI-powered OSCE coaching simulation consisting of 6-8 infertility counseling micro-scenarios, incorporating structured feedback and deliberate practice cycles. The control group will receive conventional infertility counseling education using standard teaching methods.
Outcomes will be assessed using the Therapeutic Communication Skills Scale for Nursing Students, the Jefferson Scale of Empathy for Nursing Students, and a rubric-based infertility counseling communication performance assessment based on the Kalamazoo Consensus Statement. Performance evaluations will be conducted via standardized virtual patient interviews and scored by two blinded independent raters.
Data will be analyzed using ANCOVA to assess intervention effects while controlling for baseline scores. This study aims to contribute evidence on the effectiveness of AI-supported OSCE coaching in enhancing communication and empathy skills in nursing education.
Detailed Description:
This study is designed as a two-group, randomized controlled experimental trial with a pretest-posttest design to evaluate the effectiveness of a generative artificial intelligence-based "OSCE Coach" in improving infertility counseling communication and empathy skills among nursing students. The study will be conducted at Bartın University Faculty of Health Sciences, Department of Nursing, following approval from the Bartın University Social and Humanities Ethics Committee and in accordance with the principles of the Declaration of Helsinki.
The study population will consist of undergraduate nursing students who are actively enrolled in the infertility nursing course and have successfully completed the women's health and diseases nursing course. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using a computer-generated randomization sequence. Allocation will be performed by an independent individual not involved in data collection or analysis. Due to the nature of the educational intervention, participant blinding will not be possible; however, outcome assessors evaluating OSCE performance will be blinded to group allocation.
The intervention group will receive training through a generative artificial intelligence-based "OSCE Coach" designed to support deliberate practice in infertility counseling communication. The intervention consists of 6-8 structured micro-scenarios reflecting common and challenging infertility counseling situations, including establishing rapport, psychosocial assessment, managing emotional reactions, addressing partner-related concerns, responding to social stigma, providing clear information, delivering difficult news, and closing the counseling session. In each scenario, participants will provide written counseling responses, which will be analyzed by the AI system based on therapeutic communication and empathy principles. Structured, rubric-based feedback will be provided, allowing participants to revise and repeat their responses in a deliberate practice cycle.
The control group will receive conventional infertility counseling education delivered through standard teaching methods, including lectures, written case discussions, and review of example counseling dialogues. The duration and overall educational workload of the control condition will be matched to that of the intervention group to ensure comparability between groups. No AI-supported simulation or interactive feedback will be used in the control group.
Outcome assessment will be conducted using validated self-report scales and a standardized performance-based evaluation. Therapeutic communication skills will be measured using the Therapeutic Communication Skills Scale for Nursing Students, and empathy levels will be assessed using the Jefferson Scale of Empathy for Nursing Students. Counseling performance will be evaluated through standardized virtual patient interviews conducted in an examination-mode simulation environment. All participants will complete the same virtual patient scenario under identical conditions. Performances will be scored independently by two trained evaluators using a rubric developed based on the Kalamazoo Consensus Statement. Evaluators will be blinded to participants' group assignments, and inter-rater reliability will be assessed using the intraclass correlation coefficient.
Pretest assessments will be conducted prior to the educational intervention, and posttest assessments will be completed after the intervention period. Data will be analyzed using appropriate parametric or non-parametric statistical methods based on data distribution. Analysis of covariance (ANCOVA) will be used to evaluate intervention effects while controlling for baseline scores. Effect sizes will be calculated, and statistical significance will be set at p \< 0.05.
All participant data will be anonymized using unique identification codes. Only the research team will have access to the data, which will be stored securely and used solely for scientific purposes. Participants will have the right to withdraw from the study at any time without penalty. Upon completion of the study, students in the control group will be offered optional access to the AI-based OSCE coaching system in line with ethical considerations.
The study population will consist of undergraduate nursing students who are actively enrolled in the infertility nursing course and have successfully completed the women's health and diseases nursing course. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using a computer-generated randomization sequence. Allocation will be performed by an independent individual not involved in data collection or analysis. Due to the nature of the educational intervention, participant blinding will not be possible; however, outcome assessors evaluating OSCE performance will be blinded to group allocation.
The intervention group will receive training through a generative artificial intelligence-based "OSCE Coach" designed to support deliberate practice in infertility counseling communication. The intervention consists of 6-8 structured micro-scenarios reflecting common and challenging infertility counseling situations, including establishing rapport, psychosocial assessment, managing emotional reactions, addressing partner-related concerns, responding to social stigma, providing clear information, delivering difficult news, and closing the counseling session. In each scenario, participants will provide written counseling responses, which will be analyzed by the AI system based on therapeutic communication and empathy principles. Structured, rubric-based feedback will be provided, allowing participants to revise and repeat their responses in a deliberate practice cycle.
The control group will receive conventional infertility counseling education delivered through standard teaching methods, including lectures, written case discussions, and review of example counseling dialogues. The duration and overall educational workload of the control condition will be matched to that of the intervention group to ensure comparability between groups. No AI-supported simulation or interactive feedback will be used in the control group.
Outcome assessment will be conducted using validated self-report scales and a standardized performance-based evaluation. Therapeutic communication skills will be measured using the Therapeutic Communication Skills Scale for Nursing Students, and empathy levels will be assessed using the Jefferson Scale of Empathy for Nursing Students. Counseling performance will be evaluated through standardized virtual patient interviews conducted in an examination-mode simulation environment. All participants will complete the same virtual patient scenario under identical conditions. Performances will be scored independently by two trained evaluators using a rubric developed based on the Kalamazoo Consensus Statement. Evaluators will be blinded to participants' group assignments, and inter-rater reliability will be assessed using the intraclass correlation coefficient.
Pretest assessments will be conducted prior to the educational intervention, and posttest assessments will be completed after the intervention period. Data will be analyzed using appropriate parametric or non-parametric statistical methods based on data distribution. Analysis of covariance (ANCOVA) will be used to evaluate intervention effects while controlling for baseline scores. Effect sizes will be calculated, and statistical significance will be set at p \< 0.05.
All participant data will be anonymized using unique identification codes. Only the research team will have access to the data, which will be stored securely and used solely for scientific purposes. Participants will have the right to withdraw from the study at any time without penalty. Upon completion of the study, students in the control group will be offered optional access to the AI-based OSCE coaching system in line with ethical considerations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: