Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306791237048 Date of Registration: 22/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of Using Hybrid Video Pedagogy in Teaching Catheterization among nursing students on Knowledge, Attitude, and Self-efficacy.
Official scientific title The effect of Using Hybrid Video Pedagogy in Teaching Catheterization among nursing students on Knowledge, Attitude, and Self-efficacy
Brief summary describing the background and objectives of the trial Worldwide, the appropriate and correct performance of clinical skills can enhance patients’ quality care, safety, and decreased hospital expenses. However, developing appropriate teaching and learning strategies to facilitate nursing students’ clinical skills and knowledge is a challenging task for the nursing faculty. The essence of this study is to determine the effectiveness of using hybrid video pedagogy in teaching catheterization on knowledge, attitude, and self-efficacy among nursing students in Tanzania.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/05/2023
Actual trial start date 15/06/2023
Anticipated date of last follow up 17/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 410
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Catheterization Procedure twice one week The control group will receive lecture on catheterization and a skills laboratory demonstration only. One-week post intervention the group will receive a post- test to assess their knowledge, attitude and self- efficacy. 205 Uncontrolled
Experimental Group Hybrid Video on Catheterization twice one week The interventional group will receive a hybrid video containing the lecture on catheterization and demonstration of the procedure and they will use the video for one week. 205
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study's participants will be Level 4 students pursuing Diploma in Nursing. Students studying at University of Dodoma (UDOM), St John’s University of Tanzania (SJUT), Deca College of Health and Allied Sciences (DECOHAS), Dodoma Institute of Health and Allied Sciences (DIHAS) and Mvumi Institute of Health and Allied Sciences (MIHAS), Kondoa School of Nursing and Morogoro college of Health and Allied sciences, and Kilimatinde Institute of Health and Allied Sciences. Those studying Fundamentals of Nursing. Those who will consent to participate in the study, whether living on or off campus Level 4 students pursuing Diploma in Nursing in the selected schools who have previous exposure to catheterization. Those nursing students who have enrolled in the universities by the equivalence criteria. Those who will not consent to the study Adult: 18 Year(s)-44 Year(s) 19 Year(s) 40 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
Yes 09/06/2023 The University of Dodoma Institutional Research Review Committee IRREC
Ethics Committee Address
Street address City Postal code Country
Benjamin Mkapa Street Dodoma 41107 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome variables include knowledge, defined as the state of awareness of catheterization and the effects of catheterization. Self- efficacy refers to an individual belief in their capacity to execute behaviors necessary to produce specific goals attainment as first proposed by Albert Bandura, (“Self-Efficacy,” 2019) It also reflects confidence in the ability to exert control over one’s own motivation, behavior and social environment,(Carey & Forsyth, 2009). Attitude refers to predisposition behavior of an individual which may create favorable or unfavorable feeling or emotion towards the particular object. A person’s attitude can significantly affect feelings, values, appreciation, and motivations towards something. Development or adjustment of a person’s attitude may take a considerable amount of time and effort. In general, it is difficult to assess the person’s feeling about something. It is even more difficult to measure how much change occurred in a person’s attitude as a result of training or educational activities., (Radha et al., 2019) Before the intervention
Secondary Outcome The dependent variables include knowledge, defined as the state of awareness of catheterization and the effects of catheterization. Self- efficacy refers to an individual belief in their capacity to execute behaviors necessary to produce specific goals attainment as first proposed by Albert Bandura, (“Self-Efficacy,” 2019) It also reflects confidence in the ability to exert control over one’s own motivation, behavior and social environment,(Carey & Forsyth, 2009). Attitude refers to predisposition behavior of an individual which may create favorable or unfavorable feeling or emotion towards the particular object. A person’s attitude can significantly affect feelings, values, appreciation, and motivations towards something. Development or adjustment of a person’s attitude may take a considerable amount of time and effort. In general, it is difficult to assess the person’s feeling about something. It is even more difficult to measure how much change occurred in a person’s attitude as a result of training or educational activities., (Radha et al., 2019) After the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dodoma Hospital Hospital street Dodoma United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Personal Funds Iringa road Dodoma 41110 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Miriam Mugo Iringa Road Dodoma 41110 United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Fabiola Mushi Benjamin Mkapa Street Dodoma 41107 United Republic of Tanzania
Stephen Kibusi Benjamin Mkapa Street Dodoma 41107 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Miriam Mugo miemutrg@gmail.com +255782373676 Iringa Road
City Postal code Country Position/Affiliation
Dodoma 41110 United Republic of Tanzania Student
Role Name Email Phone Street address
Public Enquiries Fabiola Moshi Fabiola.moshi@gmail.com +255767837019 Benjamin Mkapa
City Postal code Country Position/Affiliation
Dodoma 41107 United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Scientific Enquiries Stephen Kibusi skibusi@gmail.com +255712600966 Benjamin Mkapa
City Postal code Country Position/Affiliation
Dodoma 41107 United Republic of Tanzania Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data collected during the trial after deidentification will be available following publication to anyone who wishes to access the data through the University of Dodoma repository or the publication journals. Informed Consent Form,Study Protocol 4 months Hybrid Video Pedagogy
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