Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000569606
Ethics application status
Approved
Date submitted
25/03/2023
Date registered
25/05/2023
Date last updated
11/08/2024
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of written wound care discharge guidelines in Urdu on the knowledge and satisfaction of postsurgical patients: a quasi-experimental trial
Scientific title
Impact of written wound care discharge guidelines in Urdu on the knowledge and satisfaction of postsurgical patients: a quasi-experimental trial
Secondary ID [1] 309278 0
none
Universal Trial Number (UTN)
1111-1290-1624
Trial acronym
none
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
knowledge of patients on postsurgical wound care 329435 0
Condition category
Condition code
Public Health 326378 326378 0 0
Health promotion/education
Surgery 326379 326379 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention: A standard (non-specific for each patient) printed guideline on postsurgical wound care was explicitly designed for this study. The guideline covers four domains of information;1) problems that patients could face during wound healing,2)how to change the wound dressing at home if needed, and 3)how to care for wound stitches,4)thing to do or not to do during the wound healing period. The guideline is translated into the native language (Urdu) and contains simple images and figures for illustration.
mode of delivery: an intervention group is a group that will read written postsurgical wound care guideline explicitly designed for this study and then fills out a questionnaire. A time of 40-60 minutes will be given to the patient to properly read and understand the guidelines. however, if the patient is a slow reader more time will be granted to him/her .researcher will accompany the patient to make sure that the patient is reading guidelines or not. For the intervention group, a questionnaire will be given to patients after they have read and understood the written discharge guideline.
time of intervention delivery and assessment: at the time of the patient getting discharged
Intervention code [1] 325714 0
Treatment: Other
Comparator / control treatment
Control group: group only gets postsurgical wound care information verbally from their doctor, the verbal mode of delivery is a normal routine mode that is used by doctors from all over the country to provide postsurgical wound care information to their patients. However, in the intervention group, this verbal mode of delivery is not used rather a written guideline is provided to them. In the control group, the same questionnaire will be given to patients after they have received verbal instructions regarding their wound care and post-operative management from their healthcare professional at the time of discharge.
time of assessment: at the time of discharge
Control group
Active

Outcomes
Primary outcome [1] 334232 0
% level of patients' knowledge of postoperative wound care will be assessed by the study-specific survey, which contains 21 self-reported items covering the post-surgical wound care knowledge domain.
Timepoint [1] 334232 0
at the time of discharge of the patient (varies with patient, however Patients with a duration of stay of more than 72 hours in the hospital after surgery.
Secondary outcome [1] 419924 0
% the level of satisfaction among postsurgical patients when a written wound care guideline is provided to patients. The endpoints will be assessed by the study-specific survey, which contains 1 self-reported item for it.
Timepoint [1] 419924 0
at the time of discharge of the patient (varies with patient, however Patients with a duration of stay of more than 72 hours in the hospital after surgery
Secondary outcome [2] 422318 0
% the level of comprehension among postsurgical patients when a written wound care guideline is provided to patients. The endpoints will be assessed by the study-specific survey, which contains 1 self-reported item for it.
Timepoint [2] 422318 0
at the time of discharge of the patient (varies with patient, however Patients with a duration of stay of more than 72 hours in the hospital after surgery
Secondary outcome [3] 422319 0
.% of Patient's preference on the mode of delivery (verbally, written, or both) of post-surgical wound care instruction. The endpoints will be assessed by the study-specific survey, which contains 1 self-reported item for it.
Timepoint [3] 422319 0
at the time of discharge of the patient (varies with patient, however Patients with a duration of stay of more than 72 hours in the hospital after surgery

Eligibility
Key inclusion criteria
1. Patient who can read and understand the Urdu language.
2. Patients from 18 to 50 years of age.
3. Patients who underwent elective orthopedic or general surgery and have a clean wound (not an infected wound)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a duration of stay of more than 72 hours in the hospital after surgery.
2. Patients with contaminated and infected wounds
3. Patients who underwent minimally invasive procedures like laparoscopic and arthroscopic surgeries
4. Patients who are referred to other hospitals for further treatment on their discharge
5. Patients who don’t feel well enough to participate.
6. Patients who are mentally unstable e.g. (down syndrome or other sociological diseases)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
study investigator identified patients getting discharged on a day and sent their MR number to the independent reviewer via msg or WhatsApp and the independent reviewer send back a random number to the investigator through msg or WhatsApp.the independent reviewer is not present at the intervention site (hospital) and is unaware of the study inclusion criteria. The independent reviewer is using a pre-determined allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a random number is generated by putting the MR number in excel and using random number generation function
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
will be done on the IBM SPSS Statistics version 26. the continuous variable will be reported as means ± SD and the categorical variable as frequency a percentage. Statistical analysis will be done by using student t-tests and logistic regression. A p-value of <0.05 considered a statically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2023
Actual
5/06/2023
Date of last participant enrolment
Anticipated
12/10/2023
Actual
30/03/2024
Date of last data collection
Anticipated
15/10/2023
Actual
15/04/2024
Sample size
Target
300
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 25343 0
Pakistan
State/province [1] 25343 0
karachi/sindh

Funding & Sponsors
Funding source category [1] 313473 0
Self funded/Unfunded
Name [1] 313473 0
muhammad muhib
Country [1] 313473 0
Pakistan
Primary sponsor type
Individual
Name
muhammad muhib
Address
UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh
Country
Pakistan
Secondary sponsor category [1] 315246 0
None
Name [1] 315246 0
Address [1] 315246 0
Country [1] 315246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312667 0
Research Ethics committe,United medical and dental collage
Ethics committee address [1] 312667 0
Ethics committee country [1] 312667 0
Pakistan
Date submitted for ethics approval [1] 312667 0
06/06/2022
Approval date [1] 312667 0
02/03/2023
Ethics approval number [1] 312667 0
UMDC/Ethics/14/07/21-22/06/22-03/02/23/282-311-326

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

Contacts
Principal investigator
Name 125490 0
Mr Muhammad Muhib
Address 125490 0
UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh
Country 125490 0
Pakistan
Phone 125490 0
+92213002117737
Fax 125490 0
Email 125490 0
[email protected]
Contact person for public queries
Name 125491 0
Muhammad Muhib
Address 125491 0
UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh
Country 125491 0
Pakistan
Phone 125491 0
+92213002117737
Fax 125491 0
Email 125491 0
[email protected]
Contact person for scientific queries
Name 125492 0
Muhammad Muhib
Address 125492 0
UMDC Road Near Nasir Jump Bus Stop, Sector 48 H Korangi Creek, Karachi, Karachi City, Sindh
Country 125492 0
Pakistan
Phone 125492 0
+92213002117737
Fax 125492 0
Email 125492 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


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.