- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06737276
Dietary Advice Training in Nursing Using Simulation and Interactive Fiction
December 11, 2024 updated by: Antonio Jesús Marín Paz, University of Cadiz
Dietary Advice Training in Nursing Using Simulation and Interactive Fiction: a Randomised Controlled Trial
The goal of this randomised controlled trial is to evaluate the effectiveness of training nursing students using interactive fiction and role-play simulations as teaching methodologies in improving learning and decision-making competencies related to dietary advice.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cadiz
-
Algeciras, Cadiz, Spain, 11207
- Faculty of Nursing
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- First year of the Degree in Nursing at a Spanish university who were enrolled in the subject "Food, Nutrition and Dietetics".
Exclusion Criteria:
- Lack of attendance since the beginning of the course.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group 1 (EG1)
Participants received a multimodal intervention (intervention order: interactive fiction activities and role-play simulation).
|
The case studies were prepared using interactive fiction through Twine.
Each case simulated a nursing consultation with a patient requiring dietary advice, and the patient's evolution depended on the students' choices.
All cases created had similar structures, durations, and difficulties to avoid complexity-related bias.
For each circumstance, three possible dietary advice options were offered to the patient: one option that would be ideal, one suitable option, and one unsuitable option.
Role-play activity of the nursing consultation on dietary advice according to Nemec et al. (2021) recommendations.
Ten case studies of a nursing consultation on dietary advice involving a nurse and a patient were designed with the consensus of a group of nursing professionals with expertise in food and nutrition, health literacy, and communication.
Each student was assigned a role and provided with the necessary information to play their character or understand their patient's context.
The information provided was different according to the role assigned.
They had to perform a simulation of eight minutes, similar to the time available in the student's primary care consultations in the referral health system.
Thus, the patient and the family member had to explain the situation or health problem, the professional would analyse it, and together, they would try to reach a therapeutic agreement.
After the consultation, a debriefing was carried out.
|
|
Experimental: Experimental Group 2 (EG2)
Participants received a multimodal intervention (intervention order: role-play simulation and interactive fiction activities).
|
The case studies were prepared using interactive fiction through Twine.
Each case simulated a nursing consultation with a patient requiring dietary advice, and the patient's evolution depended on the students' choices.
All cases created had similar structures, durations, and difficulties to avoid complexity-related bias.
For each circumstance, three possible dietary advice options were offered to the patient: one option that would be ideal, one suitable option, and one unsuitable option.
Role-play activity of the nursing consultation on dietary advice according to Nemec et al. (2021) recommendations.
Ten case studies of a nursing consultation on dietary advice involving a nurse and a patient were designed with the consensus of a group of nursing professionals with expertise in food and nutrition, health literacy, and communication.
Each student was assigned a role and provided with the necessary information to play their character or understand their patient's context.
The information provided was different according to the role assigned.
They had to perform a simulation of eight minutes, similar to the time available in the student's primary care consultations in the referral health system.
Thus, the patient and the family member had to explain the situation or health problem, the professional would analyse it, and together, they would try to reach a therapeutic agreement.
After the consultation, a debriefing was carried out.
|
|
No Intervention: Control Group (CG)
Participants received a conventional practical teaching based on lectures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Learning
Time Frame: Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
The assessment of the learning level during the intervention was measured by correcting the three unpublished case studies created using the interactive fiction methodology.
Each case study consisted of 6 questions with 3 possible answers (1 point for the ideal answer, 0.5 points for the adequate answer and 0 points for the inadequate answer).
For readability, the final scores were reconverted proportionally out of 10 before statistical analysis.
|
Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
|
Decision-making
Time Frame: Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
Measurement instrument: Clinical Decision-Making in Nursing Scale (CDMNS).
It comprises the search for options or alternatives, information seeking and unbiased assimilation of new information, evaluation and re-evaluation of consequences, and probing of goals and values.
|
Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
|
Quality of simulations
Time Frame: Post-test 1 (30th day), and Post-test 2 (60th day)
|
Measurement instrument: Simulation Design Scale (SDS).
This scale measures students' perceptions of 5 dimensions related to simulation design: information, support, problem-solving, guided feedback and fidelity.
|
Post-test 1 (30th day), and Post-test 2 (60th day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enjoyable experience
Time Frame: Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
Measurement instrument: Gameful Experience Gamification (GAMEX) scale.
It measures 6 dimensions of students' experience in gamified experiences or environments involving interactive enjoyment mechanisms.
|
Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
|
|
Satisfaction
Time Frame: Post-test 1 (30th day), and Post-test 2 (60th day)
|
Measurement instrument: Student Satisfaction and Self-Confidence in Learning Scale (SCLS).
It has 5 items on student satisfaction with instructional methods, learning materials and instructors, as well as 8 items on self-confidence in learning.
|
Post-test 1 (30th day), and Post-test 2 (60th day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio-Jesús Marín-Paz, PhD, University of Cadiz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Lei YY, Zhu L, Sa YTR, Cui XS. Effects of high-fidelity simulation teaching on nursing students' knowledge, professional skills and clinical ability: A meta-analysis and systematic review. Nurse Educ Pract. 2022 Mar;60:103306. doi: 10.1016/j.nepr.2022.103306. Epub 2022 Feb 2.
- Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010 Mar 24;7(3):e1000251. doi: 10.1371/journal.pmed.1000251.
- Hegland PA, Aarlie H, Stromme H, Jamtvedt G. Simulation-based training for nurses: Systematic review and meta-analysis. Nurse Educ Today. 2017 Jul;54:6-20. doi: 10.1016/j.nedt.2017.04.004. Epub 2017 Apr 19.
- Pagliai G, Dinu M, Madarena MP, Bonaccio M, Iacoviello L, Sofi F. Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Br J Nutr. 2021 Feb 14;125(3):308-318. doi: 10.1017/S0007114520002688. Epub 2020 Aug 14.
- Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378.
- Marquez-Hernandez VV, Garrido-Molina JM, Gutierrez-Puertas L, Garcia-Viola A, Aguilera-Manrique G, Granados-Gamez G. How to measure gamification experiences in nursing? Adaptation and validation of the Gameful Experience Scale [GAMEX]. Nurse Educ Today. 2019 Oct;81:34-38. doi: 10.1016/j.nedt.2019.07.005. Epub 2019 Jul 12.
- Farres-Tarafa M, Bande D, Roldan-Merino J, Hurtado-Pardos B, Biurrun-Garrido A, Molina-Raya L, Raurell-Torreda M, Casas I, Lorenzo-Seva U. Reliability and validity study of the Spanish adaptation of the "Student Satisfaction and Self-Confidence in Learning Scale" (SCLS). PLoS One. 2021 Jul 23;16(7):e0255188. doi: 10.1371/journal.pone.0255188. eCollection 2021.
- Ludin SM. Does good critical thinking equal effective decision-making among critical care nurses? A cross-sectional survey. Intensive Crit Care Nurs. 2018 Feb;44:1-10. doi: 10.1016/j.iccn.2017.06.002. Epub 2017 Jun 26.
- Correa-Rodriguez M, Pocovi G, Schmidt-RioValle J, Gonzalez-Jimenez E, Rueda-Medina B. Assessment of dietary intake in Spanish university students of health sciences. Endocrinol Diabetes Nutr (Engl Ed). 2018 May;65(5):265-273. doi: 10.1016/j.endinu.2018.01.005. Epub 2018 Mar 26. English, Spanish.
- Nemec R, Brower E, Allert J. A Guide to Implementing Role-Play in the Nursing Classroom. Nurs Educ Perspect. 2021 Nov-Dec 01;42(6):E163-E164. doi: 10.1097/01.NEP.0000000000000678.
- Jeffries PR, Rodgers B, Adamson K. NLN Jeffries Simulation Theory: Brief Narrative Description. Nurs Educ Perspect. 2015 Sep-Oct;36(5):292-3. doi: 10.5480/1536-5026-36.5.292. No abstract available.
- Lo YT, Yang CC, Yeh TF, Tu HY, Chang YC. Effectiveness of immersive virtual reality training in nasogastric tube feeding education: A randomized controlled trial. Nurse Educ Today. 2022 Dec;119:105601. doi: 10.1016/j.nedt.2022.105601. Epub 2022 Oct 12.
- Karkada S, Radhakrishnan J, Natarajan J, Matua GA, Kaddoura M. Knowledge and Competency of Novice Nursing Students in Nasogastric Tube Feeding: Is Simulation Better than Case Scenario? Oman Med J. 2019 Nov;34(6):528-533. doi: 10.5001/omj.2019.96.
- Bridenbaugh JR, Tomesko J, Sandiford D, Tracey DL. Enteral Nutrition Simulation Workshop Enhances Knowledge and Skills of Graduate Nutrition Students. J Nutr Educ Behav. 2023 Apr;55(4):311-315. doi: 10.1016/j.jneb.2022.11.003. Epub 2023 Jan 18. No abstract available.
- Tinoco JDS, Enders BC, Sonenberg A, Lira ALBC. Virtual clinical simulation in nursing education: a concept analysis. Int J Nurs Educ Scholarsh. 2021 Jun 18;18(1). doi: 10.1515/ijnes-2020-0001.
- Bordelon CJ, Smith TS, Wood T, Watts P. Simulation to Enhance Communication Skills in Neonatal Nursing Practice. Neonatal Netw. 2020 Nov 1;39(6):347-355. doi: 10.1891/0730-0832/11-T-674.
- Lame G, Dixon-Woods M. Using clinical simulation to study how to improve quality and safety in healthcare. BMJ Simul Technol Enhanc Learn. 2020 Mar 4;6(2):87-94. doi: 10.1136/bmjstel-2018-000370. Epub 2018 Sep 29.
- Shea A, Brophy L, Nininger J, Abbott M, Wilson L. Nutrition integration across the nursing curriculum: A novel teaching model within a pre-licensure program. J Prof Nurs. 2021 Nov-Dec;37(6):1162-1166. doi: 10.1016/j.profnurs.2021.10.006. Epub 2021 Oct 28.
- Gianfrancesco C, Johnson M. Exploring the provision of diabetes nutrition education by practice nurses in primary care settings. J Hum Nutr Diet. 2020 Apr;33(2):263-273. doi: 10.1111/jhn.12720. Epub 2019 Dec 2.
- Tangvik RJ, Tell GS, Guttormsen AB, Eisman JA, Henriksen A, Nilsen RM, Ranhoff AH. Nutritional risk profile in a university hospital population. Clin Nutr. 2015 Aug;34(4):705-11. doi: 10.1016/j.clnu.2014.08.001. Epub 2014 Aug 12.
- Correia MITD, Perman MI, Waitzberg DL. Hospital malnutrition in Latin America: A systematic review. Clin Nutr. 2017 Aug;36(4):958-967. doi: 10.1016/j.clnu.2016.06.025. Epub 2016 Jul 19.
- Xu X, Parker D, Ferguson C, Hickman L. Where is the nurse in nutritional care? Contemp Nurse. 2017 Jun;53(3):267-270. doi: 10.1080/10376178.2017.1370782. No abstract available.
- Gan T, Cheng HL, Tse MYM. A systematic review of nurse-led dietary interventions for cancer patients and survivors. Asia Pac J Oncol Nurs. 2021 Dec 29;9(2):81-87. doi: 10.1016/j.apjon.2021.12.013. eCollection 2022 Feb.
- Crimarco A, Landry MJ, Gardner CD. Ultra-processed Foods, Weight Gain, and Co-morbidity Risk. Curr Obes Rep. 2022 Sep;11(3):80-92. doi: 10.1007/s13679-021-00460-y. Epub 2021 Oct 22.
- Chen Z, Khandpur N, Desjardins C, Wang L, Monteiro CA, Rossato SL, Fung TT, Manson JE, Willett WC, Rimm EB, Hu FB, Sun Q, Drouin-Chartier JP. Ultra-Processed Food Consumption and Risk of Type 2 Diabetes: Three Large Prospective U.S. Cohort Studies. Diabetes Care. 2023 Jul 1;46(7):1335-1344. doi: 10.2337/dc22-1993.
- Elizabeth L, Machado P, Zinocker M, Baker P, Lawrence M. Ultra-Processed Foods and Health Outcomes: A Narrative Review. Nutrients. 2020 Jun 30;12(7):1955. doi: 10.3390/nu12071955.
- Blanco-Rojo R, Sandoval-Insausti H, Lopez-Garcia E, Graciani A, Ordovas JM, Banegas JR, Rodriguez-Artalejo F, Guallar-Castillon P. Consumption of Ultra-Processed Foods and Mortality: A National Prospective Cohort in Spain. Mayo Clin Proc. 2019 Nov;94(11):2178-2188. doi: 10.1016/j.mayocp.2019.03.035. Epub 2019 Oct 14.
- Mazza E, Ferro Y, Pujia R, Mare R, Maurotti S, Montalcini T, Pujia A. Mediterranean Diet In Healthy Aging. J Nutr Health Aging. 2021;25(9):1076-1083. doi: 10.1007/s12603-021-1675-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 11, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 11, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- sol-202200229602-tra
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All data generated and teaching materials created for the interventions.
IPD Sharing Time Frame
Unending.
IPD Sharing Access Criteria
All data from this study will be available upon request to the author by correspondence, under justified reasons.
The teaching material created for the interventions will be deposited in the university's institutional repository.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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