Simulation TrainingNCT06737276
Dietary Advice Training in Nursing Using Simulation and Interactive Fiction
A study testing Interactive fiction activities and Role-play simulation in people with Simulation Training and Computer Simulation, run by University of Cadiz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Simulation Training, Computer Simulation, Diet, Food, and Nutrition
- What is being tested?
- Interactive fiction activities and Role-play simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First year of the Degree in Nursing at a Spanish university who were enrolled in the subject "Food, Nutrition and Dietetics".
Who cannot join
- Lack of attendance since the beginning of the course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Simulation Training, Computer Simulation, Diet, Food, and Nutrition, Nutrition Assessment, Nutrition Therapy, Education, Nursing
- Being tested
- Interactive fiction activities, Role-play simulation
- Keywords
- Simulation Training, Computer Simulation, Diet, Food, and Nutrition, Nutrition Assessment, Nutrition Therapy, Education, Nursing, Teaching Innovation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive fiction activitiesOther
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 simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 (EG1) | Experimental | Participants received a multimodal intervention (intervention order: interactive fiction activities and role-play simulation). Receives: Other: Interactive fiction activities; Other: Role-play simulation |
| Experimental Group 2 (EG2) | Experimental | Participants received a multimodal intervention (intervention order: role-play simulation and interactive fiction activities). Receives: Other: Interactive fiction activities; Other: Role-play simulation |
| Control Group (CG) | No intervention | Participants received a conventional practical teaching based on lectures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post-test 1 (30th day), and Post-test 2 (60th day)
Secondary outcomes (2)
Enjoyable experience
Measurement instrument: Gameful Experience Gamification (GAMEX) scale. It measures 6 dimensions of students' experience in gamified experiences or environments involving interactive enjoyment mechanisms.
Measured: Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)
Satisfaction
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.
Measured: Post-test 1 (30th day), and Post-test 2 (60th day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Feb 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a two-stage simultaneous parallel (CG) and crossover (EG1 and EG2) randomised controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Jesús Marín Paz, University of Cadiz
- Investigators
- Antonio-Jesús Marín-Paz, PhD, Principal investigator, University of Cadiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737276
- Sponsor's protocol ID
- sol-202200229602-tra
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated and teaching materials created for the interventions.
Publications
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.
PubMed 20352064World 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.
PubMed 24141714Marquez-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.
PubMed 31319349Farres-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.
PubMed 34297773Ludin 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.
PubMed 28663105Correa-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.
PubMed 29599102Nemec 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.
PubMed 32472870Jeffries 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.
PubMed 26521496Dwan 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.
PubMed 31366597Lo 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.
PubMed 36244254Karkada 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.
PubMed 31745417Bridenbaugh 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.
PubMed 36670026Tinoco 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.
PubMed 34139113Lei 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.
PubMed 35202957Bordelon 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.
PubMed 33318231
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Advice Training in Nursing Using Simulation and Interactive Fiction: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06737276
- Acronym / sponsor ID
- sol-202200229602-tra
- Conditions
- Simulation Training, Computer Simulation, Diet, Food, and Nutrition, Nutrition Assessment, Nutrition Therapy, Education, Nursing
- Keywords
- Simulation Training, Computer Simulation, Diet, Food, and Nutrition, Nutrition Assessment, Nutrition Therapy, Education, Nursing, Teaching Innovation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a two-stage simultaneous parallel (CG) and crossover (EG1 and EG2) randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 (EG1) | Experimental | Other: Interactive fiction activities, Other: Role-play simulationParticipants received a multimodal intervention (intervention order: interactive fiction activities and role-play simulation). |
| Experimental Group 2 (EG2) | Experimental | Other: Interactive fiction activities, Other: Role-play simulationParticipants received a multimodal intervention (intervention order: role-play simulation and interactive fiction activities). |
| Control Group (CG) | No intervention | –Participants received a conventional practical teaching based on lectures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First year of the Degree in Nursing at a Spanish university who were enrolled in the subject "Food, Nutrition and Dietetics".
Key exclusion criteria (1 listed)
- Lack of attendance since the beginning of the course.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive fiction activitiesThe 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. | Other | Experimental Group 1 (EG1), Experimental Group 2 (EG2) |
| Role-play simulationRole-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. | Other | Experimental Group 1 (EG1), Experimental Group 2 (EG2) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Enjoyable experience
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 20352064Schulz 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.
- Background: PubMed 24141714World 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.
- Background: PubMed 31319349Marquez-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.
- Background: PubMed 34297773Farres-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.
- Background: PubMed 28663105Ludin 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.
- Background: PubMed 29599102Correa-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.
- Background: PubMed 32472870Nemec 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.
- Background: PubMed 26521496Jeffries 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.
- Background: PubMed 31366597Dwan 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.
- Background: PubMed 36244254Lo 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.
- Background: PubMed 31745417Karkada 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.
- Background: PubMed 36670026Bridenbaugh 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.
- Individual participant dataSharing planned: Yes. All data generated and teaching materials created for the interventions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio-Jesús Marín-Paz, PhD principal investigator
University of Cadiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive fiction activities and Role-play simulation in people with Simulation Training and Computer Simulation, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning (time frame: Pre-test (0 day), Post-test 1 (30th day), and Post-test 2 (60th day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737276, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.