Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001289909
Ethics application status
Approved
Date submitted
12/12/2019
Date registered
30/11/2020
Date last updated
30/11/2020
Date data sharing statement initially provided
30/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Islamic based nurses’ competencies in disaster response in Banda Aceh hospital, Indonesia
Scientific title
The impact of enhancing Islamic-based nurses’ competencies in disaster response on managing psychological, psychosocial, and spiritual problems in Banda Aceh hospital, Indonesia
Secondary ID [1] 300083 0
None
Universal Trial Number (UTN)
U1111-1240-3438
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Nurses’ competencies in disaster response
 315606 0
Condition category
Condition code
Emergency medicine 313896 313896 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Evidence Based Intervention (EBI): comprised six sessions about training programs of nurses' competencies in disaster response. The intervention is carried out on a group of nurses according to the inclusion criteria at selected hospital that is determined by random sampling at the Banda Aceh hospital, Indonesia. Frequency of session is 90 minutes/session per week for six weeks. The intervention program will be delivered by two senior nurses who have expertise in disaster nursing and psychiatric health nursing from the Faculty of Nursing and one psychologist from the Psychology Program the Faculty of Medicine at Universitas Syiah Kuala. The module related nurses’ competencies in disaster response are used as a training material in delivering the program. The content of module adopted from International Council of Nurses (ICN) and World Health Organization (WHO) 2009, The European Network for Traumatic Stress / TENTS (2008), Hughes et al, (2017) concerning disaster response competencies in nurses for handling psychological, psychosocial and spiritual problems. Intervention is provided by lecturing, discussion, video, demonstration, role play, and storytelling methods.
The content of each of the sessions are as follow:
Session 1: Introduction and fostering trusting relationships between respondents
Session 2: Disaster concept
Session 3: Nurses’ competencies in disaster response in managing psychological problems
Session 4: Nurses’ competencies in disaster response in managing psychosocial problems
Session 5: Nurses’ competencies in disaster response in managing spiritual problems
Session 6: Review, conclusion and follow-up plan
Each session will be evaluated training process by the researcher with deliver three questions asked to participants. The strategy is used to maintain or improve fidelity of participants by giving door prizes for each session, snacks and food, and transportation fee, also obtaining a 6 credit point training certificate from the Indonesian National Nurses Association.
Group 2: Islamic based intervention (IBI): Islamic based intervention: comprised six sessions of training programs on Islamic nurses' competencies in disaster response. The intervention was carried out on a group of nurses according to the inclusion criteria at selected hospital that was determined by random sampling at the Banda Aceh hospital, Indonesia. Frequency of session is 90 minutes/session per week for six weeks. The intervention program will be delivered by two senior nurses who have expertise in disaster nursing and psychiatric health nursing from the Faculty of Nursing at Universitas Syiah Kuala and one Islamic psychologist from Universitas Islam Negeri Ar-Raniry Banda Aceh. The module related Islamic nurses’ competencies in disaster response are used as a training material in delivering the intervention program. The content of module adopted from the Standar dan Instrumen Sertifikasi Rumah Sakit Syariah (MUKISI, 2014) developed from the Al-Qur'an and hadiths. Intervention is provided by lecturing, discussion, video, demonstration, role play, and storytelling methods.

The content of each of the sessions are as follow:
Session 1: Introduction and fostering trusting relationships between respondents
Session 2: Disaster concept in Islamic perspective
Session 3: Islamic nurses’ competencies in disaster response in managing psychological problems
Session 4: Islamic nurses’ competencies in disaster response in managing psychosocial problems
Session 5: Islamic nurses’ competencies in disaster response in managing spiritual problems
Session 6: Review, conclusion and follow-up plan
Each session will be evaluated training process by the researcher with deliver three questions asked to participants. The strategy is used to maintain or improve fidelity of participants by giving door prizes for each session, snacks and food, and transportation fee, also obtaining a 6 credit point training certificate from the Indonesian National Nurses Association.
Intervention code [1] 316353 0
Prevention
Intervention code [2] 316355 0
Behaviour
Comparator / control treatment
Group 3: control group: In this group there is no intervention during the study (routine daily care).
Control group
Active

Outcomes
Primary outcome [1] 322288 0
Nurses' knowledge in disaster response assessed by using the Nurses' competencies disaster Response Questionaniare (NCDR). It was a self-report questionnaire prepared specifically for this study, The questionnaires consisted of 20 items in multiple-choice format.
Timepoint [1] 322288 0
Baseline, 2 weeks and 4 weeks after intervention commencement by using self-report questionnaire related nurses' knowledge in disaster response
Primary outcome [2] 323044 0
Nurses' skills in disaster response assessed by a self-report questionnaire prepared specifically for the use in this study, It includes 20 items in dichotomous format.
Timepoint [2] 323044 0
Baseline, 2 weeks and 4 weeks after intervention commencement by self-report questionnaire related nurses' skills in disaster response
Secondary outcome [1] 377982 0

Nurses' attitude in disaster response assessed by a self-report questionnaire prepared specifically for the use in this study, It includes 20 statements which are presented in five points Likert scale format, With responses ranging from 1 (strongly disagree) to 5 (strongly agree) for positively worded items, and 5 (strongly disagree) to 1 (strongly agree) for negatively worded items. Total score from 20-100. A higher score indicates that a high competencies related to attitude in disaster response.
Timepoint [1] 377982 0
Baseline, 2 weeks and 4 weeks after intervention commencement by self-report questionnaire related nurses' skills in disaster response

Eligibility
Key inclusion criteria
a)The nurses in the selected hospitals who worked at emergency department, intensive care unit, medical care ward, surgical care ward, b) Working period greater than or equal to 2 years, c) Minimum education level diploma, d) Not undergoing annual leave/study assignment. The nurses will be provided with written informed consent.
Minimum age
23 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The nurses in the selected hospitals who could not work at the criteria wards, working experience as a nurse less than 2 years, and being on leave/study assignments.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
1). Three hospitals were selected for the study using random sampling procedure with the help of Head of Nursing in selected hospitals.
2). The selected hospitals were assigned to be either a control group or one of the intervention groups using random sampling procedure, with one hospital per each group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1) List hospitals numbers
2) Generate group code
3) Generate random numbers of participant using Microsoft excel
4) Sort, copy, and paste the random numbers with the group code
5) Summarize the result
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using pre-post control group design (t -test) in three groups and repeated measure one way ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2021
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
21/04/2021
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 22181 0
Indonesia
State/province [1] 22181 0
Aceh

Funding & Sponsors
Funding source category [1] 304530 0
University
Name [1] 304530 0
Universitas Syiah Kuala
Country [1] 304530 0
Indonesia
Primary sponsor type
University
Name
Universitas Syiah Kuala, Darussalam-Banda Aceh, Indonesia
Address
Jl. Tgk Abdur Rauf, Darussalam, Banda Aceh, Aceh, Indonesia, Post code 23111
website:: www.unsyiah.ac.id
Country
Indonesia
Secondary sponsor category [1] 305181 0
None
Name [1] 305181 0
None
Address [1] 305181 0
None
Country [1] 305181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304962 0
Provincial Hospital Ethics Committee of dr. Zainoel Abidin in Banda Aceh
Ethics committee address [1] 304962 0
Ethics committee country [1] 304962 0
Indonesia
Date submitted for ethics approval [1] 304962 0
15/12/2018
Approval date [1] 304962 0
25/01/2019
Ethics approval number [1] 304962 0
1171012P

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98778 0
Mrs Cut Husna
Address 98778 0
Jl. Tgk. Tanoh Abe, Faculty of Nursing, Universitas Syiah Kuala, Darussalam, Banda Aceh, Aceh Province, Indonesia, postcode 23111
Country 98778 0
Indonesia
Phone 98778 0
+6285210097237
Fax 98778 0
+62-651-7555249
Email 98778 0
[email protected]
Contact person for public queries
Name 98779 0
Cut Husna
Address 98779 0
Jl. Tgk. Tanoh Abe, Faculty of Nursing, Universitas Syiah Kuala, Darussalam, Banda Aceh, Aceh Province, Indonesia, postcode 23111
Country 98779 0
Indonesia
Phone 98779 0
+6285210097237
Fax 98779 0
+626517555249
Email 98779 0
[email protected]
Contact person for scientific queries
Name 98780 0
Cut Husna
Address 98780 0
Jl. Tgk. Tanoh Abe, Faculty of Nursing, Universitas Syiah Kuala, Darussalam, Banda Aceh, Aceh Province, Indonesia, postcode 23111
Country 98780 0
Indonesia
Phone 98780 0
+6285210097237
Fax 98780 0
+62-651-7555249
Email 98780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.