NCT06737276

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

December 5, 2024

Last Update Submit

December 11, 2024

Conditions

Keywords

Simulation TrainingComputer SimulationDiet, Food, and NutritionNutrition AssessmentNutrition TherapyEducation, NursingTeaching Innovation

Outcome Measures

Primary Outcomes (3)

  • Learning

    The assessment of the learning level during the intervention was measured by correcting the three unpublished case studies created using the interactive fiction methodology.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

    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

    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 Outcomes (2)

  • Enjoyable experience

    Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)

  • Satisfaction

    Post-test 1 (30th day), and Post-test 2 (60th day)

Study Arms (3)

Experimental Group 1 (EG1)

EXPERIMENTAL

Participants received a multimodal intervention (intervention order: interactive fiction activities and role-play simulation).

Other: Interactive fiction activitiesOther: Role-play simulation

Experimental Group 2 (EG2)

EXPERIMENTAL

Participants received a multimodal intervention (intervention order: role-play simulation and interactive fiction activities).

Other: Interactive fiction activitiesOther: Role-play simulation

Control Group (CG)

NO INTERVENTION

Participants received a conventional practical teaching based on lectures.

Interventions

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.

Experimental Group 1 (EG1)Experimental Group 2 (EG2)

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 Group 1 (EG1)Experimental Group 2 (EG2)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First year of the Degree in Nursing at a Spanish university who were enrolled in the subject "Food, Nutrition and Dietetics".

You may not qualify if:

  • Lack of attendance since the beginning of the course.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (29)

  • 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.

    PMID: 20352064BACKGROUND
  • 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.

    PMID: 24141714BACKGROUND
  • 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.

    PMID: 31319349BACKGROUND
  • 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.

    PMID: 34297773BACKGROUND
  • 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.

    PMID: 28663105BACKGROUND
  • 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.

    PMID: 29599102BACKGROUND
  • 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.

    PMID: 32472870BACKGROUND
  • 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.

    PMID: 26521496BACKGROUND
  • 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.

    PMID: 31366597BACKGROUND
  • 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.

    PMID: 36244254BACKGROUND
  • 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.

    PMID: 31745417BACKGROUND
  • 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.

    PMID: 36670026BACKGROUND
  • 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.

    PMID: 34139113BACKGROUND
  • 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.

    PMID: 35202957BACKGROUND
  • 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.

    PMID: 33318231BACKGROUND
  • 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.

    PMID: 32133154BACKGROUND
  • 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.

    PMID: 28456053BACKGROUND
  • 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.

    PMID: 34887035BACKGROUND
  • 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.

    PMID: 31793070BACKGROUND
  • 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.

    PMID: 25159298BACKGROUND
  • 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.

    PMID: 27499391BACKGROUND
  • 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.

    PMID: 28920553BACKGROUND
  • 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.

    PMID: 35529414BACKGROUND
  • 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.

    PMID: 34677812BACKGROUND
  • 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.

    PMID: 36854188BACKGROUND
  • 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.

    PMID: 32792031BACKGROUND
  • 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.

    PMID: 32630022BACKGROUND
  • 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.

    PMID: 31623843BACKGROUND
  • 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.

    PMID: 34725664BACKGROUND

Study Officials

  • Antonio-Jesús Marín-Paz, PhD

    University of Cadiz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The researchers were blinded concerning the randomisation sequence and the allocation of participants to the interventions.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study is a two-stage simultaneous parallel (CG) and crossover (EG1 and EG2) randomised controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 17, 2024

Study Start

February 1, 2022

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

All data generated and teaching materials created for the interventions.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Unending.
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.

Locations