Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000651684
Ethics application status
Approved
Date submitted
29/12/2022
Date registered
15/06/2023
Date last updated
15/06/2023
Date data sharing statement initially provided
15/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Manual lymphatic drainage and brushing during the early postoperative period after cesarean section.
Scientific title
Effects of manual lymphatic drainage and brushing in women with cesarean section during the early postoperative period: a randomized controlled trial.
Secondary ID [1] 301937 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cesarean section 318477 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316478 316478 0 0
Physiotherapy
Reproductive Health and Childbirth 325978 325978 0 0
Childbirth and postnatal care
Surgery 325979 325979 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first day after cesarean section, women will be an instructed about the manual lymphatic drainage and brushing techniques. Instructions will be performed face-to-face with a physiotherapist working in the maternity ward (a member of research team). It will last for about 20 minutes. Each participant will receive the necessary equipment: a drainage brush (surgical brush) and a printed instruction with photos illustrating each technique (proprietary, created for this study). Then the participants will perform the manual lymphatic drainage and brushing on their own - from the first to the fourth day after cesarean section. Women will be instructed to perform manual lymphatic drainage and brushing 3 times a day for 10-15 minutes. Drainage will be performed both manually (gentle finger movements) and with the surgical brush described above (brushing; also gentle movements), in the following sequence: 1. Drainage of the lymph nodes in the mandible - circular movements (manual); 2. Drainage of lymph nodes in the supraclavicular and subclavian fossae - sliding and then circular movements (manual); 3. Abdominal drainage: Above the navel, upward movements, and below the navel, downward strokes, then circular movements (manual); 4. Drainage of the inguinal pits (movement from the inside out) - sliding movements and then circular movements (manual); 5. Drainage of the groin (movement from the inside out) - sliding and then circular movements (with a brush); 6. Abdominal drainage: Above the navel, upward movements, and below the navel, downwards - sliding movements and then circular movements (with a brush). The patients will be visited daily by the physiotherapist who gave them tips on lymphatic drainage (a member of the research team) and asked how they are doing. Patients will be asked to keep a participant self-report diary. Participants in the intervention group will receive the intervention in addition to standard care during the study period.
Intervention code [1] 318224 0
Rehabilitation
Intervention code [2] 325421 0
Treatment: Other
Comparator / control treatment
standard care
Standard care includes:
1. Daily medical visits
2. Daily midwife visits
3. Standard tests: body temperature, blood pressure, blood tests and other recommended if the situation requires it
4. Postoperative wound healing control
5. Postpartum droppings (lochia) control
6. Checking the child's condition: bilirubin level, blood count
7. Breastfeeding tutorial (on request)
8. Help in caring for a newborn (e.g. bathing)
Control group
Active

Outcomes
Primary outcome [1] 324627 0
scar quality (with The Patient and Observer Scar Assessment Scale)
Timepoint [1] 324627 0
before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)
Primary outcome [2] 324628 0
scar quality (with Vancouver Scar Scale)
Timepoint [2] 324628 0
before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)
Secondary outcome [1] 385260 0
quality of life (with 36-Item Short Form Survey (SF-36))
Timepoint [1] 385260 0
before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)
Secondary outcome [2] 385261 0
self-rated depressive symptoms (with The Beck Depression Inventory)
Timepoint [2] 385261 0
before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)

Eligibility
Key inclusion criteria
Primiparous women after cesarean section delivery.
Age between 20-40 years.
Alive newborn born not earlier than 37 weeks of gestation
APGAR 9-10.
Physiological pregnancy.
The transverse incision.
Provided informed consent prior to commencing the study.
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Postoperative wound infection.
Perinatal trauma of the uterus and / or abdominal wall.
Mental health disorders.
Second degree obesity before pregnancy (BMI > 35).
Intellectual or motor disability.
Multiple sclerosis.
Cancer

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
15/09/2023
Actual
Date of last data collection
Anticipated
19/09/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 22808 0
Poland
State/province [1] 22808 0

Funding & Sponsors
Funding source category [1] 306351 0
University
Name [1] 306351 0
Poznan University School of Physical Education
Country [1] 306351 0
Poland
Primary sponsor type
University
Name
Poznan University School of Physical Education
Address
Poznan University School of Physical Education
Krolowej Jadwigi 27/39
61-871 Poznan
Country
Poland
Secondary sponsor category [1] 306859 0
None
Name [1] 306859 0
Address [1] 306859 0
Country [1] 306859 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306562 0
Bioethics committee - Poznan University of Medical Sciences
Ethics committee address [1] 306562 0
Ethics committee country [1] 306562 0
Poland
Date submitted for ethics approval [1] 306562 0
Approval date [1] 306562 0
10/06/2020
Ethics approval number [1] 306562 0

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

Contacts
Principal investigator
Name 104290 0
Dr Malgorzata Chochowska
Address 104290 0
Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski
Country 104290 0
Poland
Phone 104290 0
+48570950823
Fax 104290 0
Email 104290 0
[email protected]
Contact person for public queries
Name 104291 0
Anita Kulik
Address 104291 0
Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski
Country 104291 0
Poland
Phone 104291 0
+48957279222
Fax 104291 0
Email 104291 0
[email protected]
Contact person for scientific queries
Name 104292 0
Anita Kulik
Address 104292 0
Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski
Country 104292 0
Poland
Phone 104292 0
+48957279222
Fax 104292 0
Email 104292 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.