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Trial registered on ANZCTR
Registration number
ACTRN12618001771246
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
29/10/2018
Date last updated
27/09/2021
Date data sharing statement initially provided
29/10/2018
Date results information initially provided
27/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Analgesia post Total Knee Replacement surgery - Comparision between Local Infiltration Analgesia and Ultrasound Guided Single Shot Adductor Canal Block.
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Scientific title
Comparison between Local Infiltration Analgesia and Ultrasound Guided Single Shot Adductor Canal Block post Total Knee Replacement Surgery.
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Secondary ID [1]
296274
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None
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Universal Trial Number (UTN)
U1111-1222-4179
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post operative Pain in Patients undergoing Total Knee Replacement Surgery
310072
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Condition category
Condition code
Anaesthesiology
308824
308824
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Title of the Study
Comparison between Local Infiltration Analgesia (LIA) and Ultrasound Guided Single Shot Adductor Canal Block (UG-SS-ACB) for post-operative pain relief in patients undergoing Total Knee Replacement surgery.
Methods:
All 60 patients enrolled for the study will receive spinal anesthesia with 0.5% bupivacaine heavy 2.8 ml with Fentanyl 20 microgram(Total volume = 3.2 ml), prior to surgery. The spinal Anesthetic will be administered in the Operation Theater (as it is the Hospital protocol). The patient will be wheeled to the operation theater and standard monitoring i.e. Electrocardiography(ECG), Pulse oximetry and Noninvasive blood pressure. After completion of the WHO surgical safety checklist and “Sign - in”, the patient will be placed in a sitting position. After proper aseptic procedures including painting the lower back with Betadine solution, a local anesthetic solution containing 1% Lidocaine 2mls will be injected in L3 - L4 interspace. Dural Puncture will be performed with 25 G Pencil Point needle, and after confirming free flow of Cerebrospinal Fluid, 3.2 ml of above-mentioned solution will be injected. There Patient will be placed in a supine position and the table tilt will be adjusted to achieve a block height between T12 and T8 sensory level. After confirming a minimum of T12 sensory level the surgical team will be allowed to clean and sterilize the limb and proceed to start the surgery. The approximate time of start of surgery from the time of spinal anesthetic in our routine cases is 30 minutes.
Group A patients will be given local infiltration analgesia at the end of surgery which will be injected at the posterior capsule (40 ml), anterior capsule (40 ml), patellar tendon (25 ml), quadriceps tendon(25 ml) and subcutaneous tissue at incision line(20 ml). The local infiltration analgesia will be prepared using a mixture of 50 ml of 0.25% bupivacaine, 10mg morphine [1ml] and 99 ml normal saline to make a volume of 150 ml.
Group B patients will be given adductor canal block under ultrasound guidance with 25 ml 0.5% bupivacaine at the mid-thigh level at the end of surgery.
Postoperatively all patients will be given Patient Controlled Analgesia(PCA) morphine 1mg bolus with a lockout of 5 minutes, the 4 hourly limits being 30 mg. In addition, all patients will receive oral paracetamol 1g every 6 Hourly and diclofenac 50mg every 8 hourly, for 24 hours starting from the end of the surgery.
The Pain management team, which consists of dedicated pain management nurses, will be notified to follow the patient and collect the data at the end of 24 hours. The pain management team will be blinded to the intervention the patient received. This team will follow up with the patient at 24 hours and collect and record the data on the data collection sheet(attached in the section of documents).
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Intervention code [1]
312681
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Treatment: Other
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Comparator / control treatment
Group A - Local Infiltration Analgesia
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Control group
Active
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Outcomes
Primary outcome [1]
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Quantitative assessment of Postoperative Pain relief by evaluating first 24 hours morphine consumption.
The log of the PCA(Patient Controlled Analgesia) Pump is retrieved by the nurse at 24 hours after the surgery and the total morphine consumption is noted on the Chart in numerics.
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Assessment method [1]
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Timepoint [1]
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0-24 Hours Post Operatively (zero time is the time of the end of surgery).
The morphine consumption is noted at following time points. 1st dose of morphine demand, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
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Primary outcome [2]
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Pain scores.
Pain scores at rest and flexion of the operated knee at 4, 6, 8, 12, 24 hours post-surgery.
A Visual Analogue Scale (VAS) is marked at one end with '0'(zero) denoting no pain and 10 denoting the worst Pain the Patient can imagine, on the other end,
The patient will be explained about the use of this scale and asked to point to a point on the scale which would describe the appropriate amount of pain he/she perceives. This will be recorded on the data collection chart in numerics.
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Assessment method [2]
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Timepoint [2]
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0 to 24 hours after the end of surgery.
Pain scores are recorded on a chart at time zero (end of surgery), 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
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Secondary outcome [1]
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Sedation scores
Sedation scores will be assessed using the Pasero opioid-induced sedation scale [POSS].
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Assessment method [1]
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Timepoint [1]
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0 to 24 hours after the end of surgery.
This is a composite secondary outcome and will note the sedation scores in the first 24 hours post-surgery at specific time points
Sedation scores are recorded on a chart at time zero (end of surgery), 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
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Secondary outcome [2]
352957
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Incidence of nausea/ vomiting.
This will be noted as a Yes/NO in appropriate boxes on the observation chart.
This is a composite secondary outcome which will note the occurrence of nausea and/or vomiting in the first 24 hours post surgery and note the time of its occurrence.
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Assessment method [2]
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Timepoint [2]
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0 to 24 hours after the end of surgery.
The incidence of Nausea and/or vomiting will be recorded in appropriate boxes on the observation chart.
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Secondary outcome [3]
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Patient satisfaction
Overall patient satisfaction scores with respect to pain relief will be assessed at the end of 24 hours’ post-op on a five-point Likert scale.
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Assessment method [3]
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Timepoint [3]
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24 hours after the end of surgery
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Eligibility
Key inclusion criteria
• Adults patients (18-75 years)
• Admitted for Total knee replacement
• ASA 1 to 3 patients
• Patients receiving spinal anesthesia for surgery
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Patients with contraindication to spinal anesthesia/ nerve block
• Patients with allergy to local anesthetics, morphine. Paracetamol and non- steroidal anti-inflammatory drugs
• Patients on regular opioid use
• ASA 4 patients
• Patient refusal
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2018
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Actual
1/11/2018
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Date of last participant enrolment
Anticipated
31/10/2019
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Actual
5/11/2019
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Date of last data collection
Anticipated
1/11/2019
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Actual
6/11/2019
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
20936
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Bahrain
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State/province [1]
20936
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Funding & Sponsors
Funding source category [1]
300867
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Hospital
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Name [1]
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King Hamad University Hospital
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Address [1]
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Building 2435, Road 2835, Block 228, Busaiteen, P.O. Box 24343
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Country [1]
300867
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Bahrain
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Primary sponsor type
Hospital
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Name
King Hamad University Hospital
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Address
Building 2435, Road 2835, Block 228, Busaiteen, P.O. Box 24343, Bahrain
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Country
Bahrain
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Secondary sponsor category [1]
300543
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None
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Name [1]
300543
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Address [1]
300543
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Country [1]
300543
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301642
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Research and Ethics, King Hamad University Hospital, Bahrain
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Ethics committee address [1]
301642
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Research and Ethics Committee,
King Hamad University Hospital,
Building 2345, Road 2835, Block 228, Busaiteen,
P. O. Box 24343, Kingdom of Bahrain.
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Ethics committee country [1]
301642
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Bahrain
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Date submitted for ethics approval [1]
301642
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Approval date [1]
301642
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17/09/2018
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Ethics approval number [1]
301642
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Ref. KHUH/Research/No.237/2018
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Summary
Brief summary
Effective analgesia in the first 24 hours post total knee replacement will ensure early ambulation and normalization of the gait pattern from a surgical perspective. It will also improve patient satisfaction, minimize post-operative cardiovascular complications and contribute to early patient discharge. This will result in better cost savings for the hospital and better management of hospital resources
This study compares 2 different modalities of post-operative pain relief in patients undergoing Total Knee Replacement Surgery. We compare the Local Infiltration Analgesia with Ultrasound Guided Single Shot Adductor Canal Block in these Patients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Priti Narayan
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Address
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Consultant, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
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Country
87638
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Bahrain
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Phone
87638
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+97333008381
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Fax
87638
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Email
87638
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[email protected]
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Contact person for public queries
Name
87639
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Dr Vijay Sahitya
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Address
87639
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Registrar, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
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Country
87639
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Bahrain
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Phone
87639
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+97335388245
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Fax
87639
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Email
87639
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[email protected]
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Contact person for scientific queries
Name
87640
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Dr Priti Narayan
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Address
87640
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Consultant, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
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Country
87640
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Bahrain
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Phone
87640
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+97333008381
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Fax
87640
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Email
87640
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
This is a new requirement, made mandatory from today i.e. 25/10/2018. The registration for this trial was started earlier and was in the review process. Furthermore, The study proposal was made and approval for it was secured from the hospitals Research and Ethics committee on 17/09/2018 without this requirement. Hence in view of all these factors, at this stage, we cannot assure what IPD we would be able to make available.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4
Ethical approval
376145-(Uploaded-25-10-2018-17-40-53)-Study-related document.pdf
5
Other
Observation sheet that will be used for data colle...
[
More Details
]
376145-(Uploaded-25-10-2018-17-41-30)-Study-related document.docx
6
Other
Scoring Systemes used in the study
376145-(Uploaded-25-10-2018-17-42-01)-Study-related document.docx
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.
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