Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12619000717156
Ethics application status
Approved
Date submitted
24/04/2019
Date registered
13/05/2019
Date last updated
13/05/2019
Date data sharing statement initially provided
13/05/2019
Date results provided
13/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health education intervention of safe patient handling on musculoskeletal disorder among nurses
Scientific title
Effect of health education intervention of safe patient handling on musculoskeletal disorder among nurses of government elderly care home nurses in West Coast Malaysia
Secondary ID [1] 298051 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal Disorder 312533 0
Condition category
Condition code
Musculoskeletal 311064 311064 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The protocol of the intervention has been published in International Journal of Public health and Clinical Science (https://doi.org/10.32827/ijphcs.6.1.222)

This study is the cluster pre-test and post-test with control group quasi experimental study design on safe patient handling among government elderly care homes nurses in West Coast Malaysia. Quasi experimental has been done due to managerial and logistic problems. This was single blinding intervention.The intervention involve health education based on health belief model theory to change the behaviour toward safe patient handling. The intervention groups were care home in Cheng Melaka, Cheras Selangor, Ulu Kinta Perak, Kuala Kubu Bharu Selangor. Control groups were Johor Bharu, Kangar Perlis, Taiping Perak and Bedong Kedah. There were 226 or nurses involved in this intervention study. after assess for eligibility, 115 nurses were in intervention groups and 111 nurses were in control groups.

The intervention development was divided into 4 elements:
1) Organisation commitment
Researcher had explained Headquarters of Social Welfare Department regarding the intervention and benefits of the intervention towards organisation, nurses and elderly. The committee of the intervention program had been developed for each care home that involve in the intervention. Work through survey had been done for assessment and the equipment of safe patient handling had been provided according to the finding. Guideline and questionnaire developed and being validated. The content of guideline presented during meeting with headquarters

2) Unit based peer leader
Supervisor had assigned 2 peer leaders in each ward and the peer leader was important to encourage the colleague to implement the intervention that had been planned by management

3) Implementation of intervention (education phase)
Questionnaire was distributed to all care homes that involve in the study to get information at baseline before the intervention was given to nurses.The health education was given within 2 months period (January until March 2018) and followed by monitoring of the implementation of 6 months duration (April until October 2018).Each nurses involved in one day training of 3 hours lecture using power point and 5 hours practical session using video. The content of three hours lecture were introduction on musculoskeletal disorder including statistic of MSD among nurses world wide and in Malaysia, pathophysiology of MSD and symptoms of MSD, explained the tasks and the risks that contribute to MSD, benefit of safe patient handling towards nurses and patient, consequences if the the nurses still practice manual handling. Emphasized on correct body posture or body mechanic while transfering the patient. Explained the principal of safe patient handling, important the elderly assessment using algorithm. Other than that the practical session on technique of safe patient handling was also has been done. The hands on session was done on 10 transferring activities. The use of algorithm for assessment was applied during this session. There were about 12 to 15 respondents attended the course training and every respondent had their opportunity to practice the techniques. The transferring activities were:
1) Transferring the patient from bed to chair or toilet using transfer board and gait belt (1 carer)
2) Transferring the patient from bed to chair or toilet using gait belt only (1 carer)
3) Re-position patient on the chair using slide sheet & pillow (1 care)
4) Transferring the patient from chair to bed using transfer board (2 carer)
5)Transferring the patient from chair to bed using mechanical lifting aid
6) Transferring patient from bed to chair using mechanical lifting aid
7) Transferring patient from floor to bed using mechanical lifting aid
8) Transferring elderly from bed to trolley using slide sheet and transfer board (2 carer)
9) Re-position the elderly on bed using slide sheet (2 carer)
10) Technique make a bed while patient on the bed (2 carer)

Prior to intervention done, guideline, pamphlet and poster of safe patient handling has been developed. The training was given by researcher herself. There were 8 session of training and it was held in Care Cheras Selangor as center of excellent for elderly in Malaysia.

4) Maintenance and monitoring phase
Committee and supervisor need to do continuous monitoring in the ward and peer leader play important role to encourage the colleague to implement the intervention. Standardized log book has been developed. The peer leader filled up the name of elderly and equipment used in log book. The supervisor need to review the log book for monitoring. After 6 month post intervention the nurses re evaluate by answering the same questionnaire to look into improvement of musculoskeletal disorder symptoms, knowledge and practice of safe patient handling
Intervention code [1] 314285 0
Prevention
Intervention code [2] 314286 0
Behaviour
Comparator / control treatment
Control also involve nurses in elderly care homes in Johor Bharu, Kangar Perlis, Taiping Perak and Bedong Kedah. Total of 111 nurses in control groups involve in this study. The control groups continue with current practice and will receive the intervention after post intervention data collection has been done in intervention groups to avoid contamination. The current practice by the nurses in control group was manual handling the patient without any equipment
Control group
Active

Outcomes
Primary outcome [1] 319845 0
to develop, implement and evaluate the effectiveness of health belief model (HBM) based educational intervention on musculoskeletal disorder (MSD) among nurses at government elderly care home in West Coast Malaysia

The symptoms of MSD was assessed through validated Nordic questionnaire
Timepoint [1] 319845 0
At baseline and 6 month post intervention
Secondary outcome [1] 369686 0
To compare the the level of knowledge safe patient handling between and within both intervention and control group

The data gather through specifically design and validated questionnaire
Timepoint [1] 369686 0
At baseline and after 6 months of intervention.
Secondary outcome [2] 369687 0
To compare the the level of practice safe patient handling between and within both intervention and control group

The data gather through specifically design and validated questionnaire
Timepoint [2] 369687 0
At baseline and 6 month post intervention
Secondary outcome [3] 369690 0
To compare health belief model constructs (perceived benefit, perceived barriers, perceived severity, perceived susceptibility, self-efficacy and cues of action) between and within both intervention and control group

The data gather through specifically design and validated questionnaire
Timepoint [3] 369690 0
At baseline and after 6 months of intervention.

Eligibility
Key inclusion criteria
The nurses is a Malaysian, permanent or temporary staff who had been working more than 12 month duration and directly manage the elderly residents.
Minimum age
19 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The nurse who are pregnant, long leave, medical leave, having spine or rheumatologic diseases or who are having MSD symptoms due trauma or accident.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Quasi experimental study (non randomization)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
The intervention groups received the safe patient handling intervention while control groups not receive any intervention but continue current practice
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation was calculated by using two proportions formula hypothesis testing by Lwanga and Lemeshow (1991). With the drop-out rate 20% and 90% respondent eligibility, the total sample size will be 232 participants with minimum cluster is 7 cluster. However 8 clusters will be involved with sample size 256 participants. Four cluster will be in intervention group and another 4 cluster will be in control group.

Data will be analysed on descriptive and inferential statistic using SPSS version 22. For bivariate analysis, The chi square test for between group and Mc Nemar’s test for within group analysis were used to analyse categorical data such as MSD symptom. The independent t test for between group and paired t test for within group analysis were used to analyse continuous data such as knowledge, practice of safe patient handling and HBM construct. For multivariate analysis, generalized linear model of Generalized Estimating Equation (GEE) will be used

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2018
Date of last participant enrolment
Anticipated
Actual
30/03/2018
Date of last data collection
Anticipated
Actual
15/01/2019
Sample size
Target
256
Accrual to date
Final
226
Recruitment outside Australia
Country [1] 21432 0
Malaysia
State/province [1] 21432 0
Perlis, Kedah, Perak, Selangor, Melaka, Johor

Funding & Sponsors
Funding source category [1] 302579 0
University
Name [1] 302579 0
Geran Universiti Putra Malaysia
Country [1] 302579 0
Malaysia
Primary sponsor type
University
Name
Geran Universiti Putra Malay
Address
Universiti Putra Malaysia, 43400 UPM Serdang, Selangor Darul Ehsan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 302487 0
None
Name [1] 302487 0
Address [1] 302487 0
Country [1] 302487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303221 0
Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Ethics committee address [1] 303221 0
Ethics committee country [1] 303221 0
Malaysia
Date submitted for ethics approval [1] 303221 0
15/02/2017
Approval date [1] 303221 0
14/04/2017
Ethics approval number [1] 303221 0
(FPSK-P035)2017

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

Contacts
Principal investigator
Name 92902 0
Dr Ezy Eriyani bt Nadzari
Address 92902 0
DU-07, Kuaters Kakitangan PLPP Bangi
Jalan Sg Merab, Bangi,
43000 Kajang
Country 92902 0
Malaysia
Phone 92902 0
+60126431450
Fax 92902 0
Email 92902 0
ezyeriyaninadzari@gmail.com
Contact person for public queries
Name 92903 0
Ezy Eriyani bt Nadzari
Address 92903 0
DU-07, Kuaters Kakitangan PLPP Bangi
Jalan Sg Merab, Bangi,
43000 Kajang
Country 92903 0
Malaysia
Phone 92903 0
+60126431450
Fax 92903 0
Email 92903 0
ezyeriyaninadzari@gmail.com
Contact person for scientific queries
Name 92904 0
Ahmad Azuhairi Bin Ariffin
Address 92904 0
Department of Community Health
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan
Country 92904 0
Malaysia
Phone 92904 0
+603-8947 2422
Fax 92904 0
Email 92904 0
zuhairifin@upm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Anonymous for confidentiality


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2013Study protocol    https://doi.org/10.32827/ijphcs.6.1.222 377461-(Uploaded-06-05-2019-14-55-59)-Study-related document.pdf



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.