ClinicalTrials.gg
CompletedNCT06405399Updated May 8, 2024

Design, Implementation and Evaluation of the Guided Observer Role in Clinical Simulation

An interventional study of Educational intervention. observation guide in Anaphylactic Reaction, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled May 2023, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
123
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study summary

The aim of this study is to assess the effectiveness of the guided observed role in a simulation learning programme for nursing students in acquiring the competence (knowledge, skills and attitudes) to care for patients affected by anaphylactic situations. This will be achieved by comparing the participants' simulation roles with the guided observed role.

The design was that of an exploratory randomised controlled trial. The variables employed to assess the efficacy of the intervention were competence and its associated attributes. These were measured using a ten-question multiple-choice test to assess knowledge; the simulation performance assessment using the Creighton Simulation Evaluation Instrument to assess skill; the learner's perception of the simulation's effectiveness in meeting their learning needs, through the Simulation Effectiveness Tool Modified (SET-M). Furthermore, the extent to which reflective thinking was achieved during the simulation was evaluated using the Self-Debriefing Reflection Rubric. Additionally, the students' perceptions of their role were assessed through seven open-ended questions.

Read the detailed description

The study was a prospective, randomised, double-blind controlled trial conducted from October to November 2023 at a Nursing Faculty. The participants were fourth-year Bachelor of Science in Nursing students from a University in the North of Spain. A convenience sample of students from the nursing programme participated in the study. The recommended sample size was 40 participants per group, accounting for a 10% allowance for withdrawals, missing data, and lost follow-up.

Following their registration to participate in the study, 123 students were screened by the researchers to determine their eligibility. Prior to the commencement of the research, the students were informed about the objectives and the project and they signed the informed consent form. Upon arrival at the simulation centre to develop the simulated experience, participants completed the pre-test assessment and were randomly assigned to either the intervention group (57 students) or the control group (56 students) at a 1:1 ratio using a computer-generated assignment. Following the simulation experience, participants completed the post-test assessment and the various tools of the research.

During the study, two participants in the intervention group and one in the control group were excluded due to missing follow-up (refusal to continue in the research), and one student in the control group was removed by statistical analysis. In total, 99 participants were included in the data analysis. The students completed the sociodemographic information (age, gender, and previous experience in simulation experiences with anaphylactic situations) and the data on different variables via the online platform Google Form.

02

Conditions studied

  • Anaphylactic Reaction

Browse trials for

Keywords

  • simulation training;
  • undergraduated students
03

In context

Anaphylaxis

100 studies on the registry are indexed under Anaphylaxis; 20 are open to participants now.

This study's enrollment of 123 is above the median of 40 across 50 interventional studies indexed under Anaphylaxis.

Browse Anaphylaxis studies →

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Students enrolled in the 4rd year of nursing at the Faculty of Nursing of the University of Navarra and who voluntarily agree to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Students who had previously undergone a simulated clinical experience of managing an anaphylactic shock.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
123 participants (actual)

Study arms

  • Experimental
    Guided observed

    Students attended the simulated clinical experience as non-participant observers, but were supported by an observation rubric. Observation took place in situ, within the simulation laboratory itself, in an adjacent video-monitored room.

    Other: Educational intervention. observation guide

  • No intervention
    Control group: Participant

    Students attended the simulated clinical experience directly as participants.

Interventions

  • OtherEducational intervention. observation guide

    An observation checklist based on the Lasater Clinical Judgment Rubric (LCJR) was created and adapted to the simulated clinical experience in order to address the learning outcomes to be achieved by nursing students. This resulted in a list of forty items divided into four main groups: patient safety (8 items), communication and relationship with the patient (7 items), teamwork (7 items) and technical skills (18 items).

    Also known as: Observation guide

06

What researchers measure

Primary outcomes

  1. Knowledge

    In order to gauge the comprehension of information pertaining to a case of anaphylactic shock, a questionnaire comprising 10 multiple-choice inquiries, each presenting four possible responses, was devised. This questionnaire encapsulates the primary algorithms delineating the contemporary approach to managing anaphylactic shock, as outlined by the European Resuscitation Council in 2021, alongside delineations of requisite nursing interventions.

    Time frame: two months

  2. Evaluation of the simulated experience: Creighton Simulation Evaluation Instrument (C-SEI)

    In order to assess the proficiency development of students allocated to the intervention group (guided observers) and the control group (participants), the Creighton Simulation Evaluation Instrument (CSEI) was employed. The CSEI, translated and validated into Spanish in 2019, comprises 22 dichotomous items divided into four different components: assessment, communication, critical creative, and technical skills. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.839. The exclusion of any one of the questions was not found to significantly enhance the internal consistency of the scale.

    Time frame: Two month

Secondary outcomes

  1. Self-Debriefing Reflection Rubric

    The tool comprised a set of six guiding questions, designed to assist with reflection on the experience based on Gibbs' (1988) Reflective Cycle. The questions are as follows: Q1-Description, Q2-Emotion, Q3-Evaluation, Q4-Analysis, Q5-Conclusion and Q6-Future Plan. The definitions of reflection levels proposed by Mezirow and the model of structured reflection were employed in the design of the Self-Debriefing Reflection Rubric for this study. The rubric comprised six items for the six questions, each with four possible rating levels. The responses were categorised as L-1 (Habitual Action), L-2 (Understanding), L-3 (Reflection), or L-4 (Critical Reflection). A mean rating of 3.0 or above for a student's submission indicated a consistent level of RT.

    Time frame: Two months

  2. Simulation Effectiveness Tool - Modified (SET-M)

    In its updated form, the SET-M (Leighton, 2015) incorporates the simulation standards of best practices and terminology that have been established by the INACSL Standards Committee (INACSL Standards of Best Practice Simulation (INACSL Standards Committee, 2016)), The Quality and Safety Education for Nurses (QSEN) competencies (2007) and the Essentials of Baccalaureate Education for Professional Nursing Practice of the American Association of Colleges of Nursing (AACN) (2008). The SET-M is a useful instrument for evaluating the learner's perception of the effectiveness of the simulation in meeting their learning needs. The SET-M comprises 19 items, scored on a 3-point Likert scale: prebriefing (2 items), learning (6 items), confidence (6 items) and debriefing (5 items). The Spanish version of the SET-M was translated and validated, resulting in an internal consistency of 0.936 (Cronbach's alpha).

    Time frame: Two months

  3. Open ended questions

    Seven open-ended questions were developed to ascertain the students' perceptions of their role (participant or guided observer) in the simulated clinical experience. A thematic review was conducted to identify the main categories, which were then used to inform the subsequent elaboration of the questions. For example, the question "Do you believe that the role of observer makes you more relaxed in the ECS?" was developed to assess the students' perceptions of the observer role. Similarly, the question "Has the observer role made you more passive in the ECS?" was designed to assess the students' views on the impact of the observer role on their behaviour.

    Time frame: Two months

07

Study locations

1 site
  • University of Navarra
    Pamplona, Navarra 31003, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Oct 2023, 5 months.

Of 13 interventional studies with no phase under Anaphylaxis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2024
First posted
May 8, 2024
StartActual
May 10, 2023
Primary completionActual
Oct 10, 2023
CompletionActual
Nov 25, 2023
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06405399
Responsible party
Sponsor
First posted
May 8, 2024
Start date
May 10, 2023
Primary completion
Oct 10, 2023
Completion
Nov 25, 2023
Last update
May 8, 2024

Study contacts

Lizarbe Marta, PhD
principal investigator · University of Navarra Pamplona, Navarra, Spain

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion