Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305505743210 Date of Approval: 16/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The impact of a virtual simulation tool on nursing students’ knowledge and skills acquisition of drug dose calculation and preparation.
Official scientific title The impact of a virtual simulation tool on nursing students’ knowledge and skill acquisition of drug dose calculation and preparation: a multicenter, single-blinded, randomized, controlled study.
Brief summary describing the background and objectives of the trial Medication administration is a continuous process that predominantly involves registered nurses. It consumes approximately 40% of nursing practice time. This process is composed of six steps: (a) Assessing the patient to obtain pertinent data, (b) Gathering and preparing medications, (c) Confirming the six rights (i.e., Right dose, patient, route, medication, time, and documentation), (d) Administering the medications, (e) Documenting administration, (f) Observing for therapeutic and untoward effects. An integrative review published in 2020 showed that using virtual simulation can promote the acquisition of essential skills in medication administration for patient safety. While several research studies have demonstrated that the use of a game-based simulation strategy can improve learning outcomes, they also highlight the need for additional research to reinforce this claim. Empirical evidence, however, is lacking about the impact of teaching drug dose calculation and preparation through virtual simulation. The primary objective of this study is to evaluate the impact of screen-based virtual simulation on undergraduate nursing students' acquisition of knowledge and skills in drug preparation and dose calculation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Screen-based virtual simulation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 08/05/2023
Actual trial start date
Anticipated date of last follow up 29/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ETHICS COMMITTEE OF THE MOHAMMED VI UNIVERSITY OF SCIENCE AND HEALTH, CASABLANCA.
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional Training Two separate sessions of one hour each In the conventional training group, students will analyze the same four cases (as the experimental group) individually, presented in text paper format and without an instructor. Afterwards, they will attend a traditional course on preparing and calculating drug doses, which will include an instructor and a PowerPoint slide kit. 150 Historical
Experimental Group Screen Based Virtual Simulation Two separate sessions of one hour each The SIMDOSE software is the tool used to answer the research questions. The experimental group will attend two one-hour sessions of the Simdose program, during which they will learn how to safely and accurately calculate drug doses and prepare different perfused drugs. All the students will undergo the same four cases: Antibiotherapy, Hydro-caloric intake, Insulin therapy, and Anti-arrhythmic. The session will take place in the computer room of the student's institution, and due to the limited number of computer stations, students will rotate according to a predefined schedule prepared in collaboration with the pedagogical coordinator. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Second-year undergraduate nursing students. Having theoretical prerequisites in terms of pharmacology and medication administration. Study specialties: general nursing, anesthesia and resuscitation nursing, emergency and intensive care nursing, neonatology nursing. Declaring Online Informed Consent (the pre-test first question). Refusal to sign the informed consent form. Reluctance to continue the research. Absence at any stage of the study. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 25/04/2023 ETHICS COMMITTEE OF THE MOHAMMED VI UNIVERSITY OF SCIENCE AND HEALTH
Ethics Committee Address
Street address City Postal code Country
Avenue Mohammed Taieb Naciri, Commune Hay Hassani Casablanca 82403 Morocco
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Undergraduate nursing students' anxiety level. First time : after having the first Simdose session. Second time : after taking the objective structured clinical examination
Primary Outcome The outcome is improvement in knowledge related to drug dose calculation and preparation, within the experimental group and between the two groups. The outcome measure is the difference between the means of the pretest and posttest for both groups. At the end of the training sessions, SIMDOSE for experimental group and conventional training for control group.
Primary Outcome The outcome is improvement in skills related to drug dose calculation and preparation. This outcome will be assessed using an observation grid, which will be completed by an outcome assessor during the objective, structured clinical examination. Immediately after the objective, structured clinical examination
Secondary Outcome Undergraduate nursing students' satisfaction. 1st time : after the posttest administration. 2nd time : after the objective structured clinical examination.
Secondary Outcome Undergraduate nursing students' self-confidence in their knowledge. 1st time : after the posttest administration. 2nd time : after the objective structured clinical examination.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Nursing and Allied Health Sciences Avenue Mohammed Taieb Naciri, Commune Hay Hassani Casablanca 82403 Morocco
The Higher Institute of Health Sciences of Settat University Complex, Casablanca road Settat 555 Morocco
The Higher School of Paramedical Sciences of Rabat Rabat International University, Technopolis Rabat-Shore, Rocade Rabat-Sale Sale 11100 Morocco
The Higher Institutes of Nursing and Health Techniques of Meknes Street Omar El Farouk Hamria Meknes 50000 Morocco
The Higher Institutes of Nursing and Health Techniques of Oujda Maghreb AL Arabi Street, Al Farabi Hospital Oujda 60000 Morocco
FUNDING SOURCES
Name of source Street address City Postal code Country
Principal Investigator Avenue Mohammed Taieb Naciri, Commune Hay Hassani Casablanca 82403 Morocco
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed VI University of Sciences and Health Avenue Mohammed Taieb Naciri, Commune Hay Hassani CASABLANCA 82403 Morocco University
COLLABORATORS
Name Street address City Postal code Country
GOUIFRANE RACHID Residence Fadaat al mohit, GH9B, Imm 18, Appt 1, Dar Bouaazza CASABLANCA 27223 Morocco
RABHAOUI EL MAHJOUB Avenue Mohammed Taieb Naciri, Commune Hay Hassani Casablanca 82403 Morocco
BELAOUCHI FOUAD Rue de sahara n41 Oujda 60000 Morocco
DECORMEILLE Guillaume 3, rue Ella maillart E127 Toulouse 31300 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fatimazahra MAHOU fmahou@um6ss.ma +212707111454 Residence Safae 4 bldg 86, apt 02 sala aljadida HSSAINE
City Postal code Country Position/Affiliation
Sale 11100 Morocco Nursing instructor and PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Fatimazahra MAHOU fmahou@um6ss.ma +212707111454 Residence Safae 4 bldg 86, apt 02 sala aljadida HSSAINE
City Postal code Country Position/Affiliation
Sale 11100 Morocco Nursing instructor and PhD candidate
Role Name Email Phone Street address
Public Enquiries Oumnia Bouaaddi obouaaddi@um6ss.ma +212676721960 Avenue Mohammed Taieb Naciri Commune Hay Hassani
City Postal code Country Position/Affiliation
Casablanca 82403 Morocco Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available, especially those that will underlie the results reported in the future article (after deidentification). The other documents that will be available are the study protocol. Data will be available immediately after publication of the results and for the next 5 years. Data will be shared with principal investigators whose proposed use has been approved by an independent review committee appointed for this purpose. For IPD meta-analysis. Data will be available for 5 years following the article's publication. Proposals should be directed to fmahou@um6ss.ma. Results will be published in an original article as well as on this clinical trial registry in PACTR. Study Protocol Data will be available immediately after publication of the results and for the next 5 years. Deidentified data may be shared upon request from the principal investigator. The quality of the requested will be assessed on a case by case basis.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information