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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cesarean section

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Reproductive Health and Childbirth

Childbirth and postnatal care

Surgery

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]

Rehabilitation

Intervention code [2]

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]

scar quality (with The Patient and Observer Scar Assessment Scale)

Timepoint [1]

before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)

Primary outcome [2]

scar quality (with Vancouver Scar Scale)

Timepoint [2]

before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)

Secondary outcome [1]

quality of life (with 36-Item Short Form Survey (SF-36))

Timepoint [1]

before intervention (on the first day after cesarean section) and after intervention (on the fourth day after cesarean section)

Secondary outcome [2]

self-rated depressive symptoms (with The Beck Depression Inventory)

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Poland

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Poznan University School of Physical Education

Address [1]

Poznan University School of Physical Education
Krolowej Jadwigi 27/39
61-871 Poznan

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bioethics committee - Poznan University of Medical Sciences

Ethics committee address [1]

ul. Bukowska 70
60-812 Poznan

Ethics committee country [1]

Poland

Date submitted for ethics approval [1]

Approval date [1]

10/06/2020

Ethics approval number [1]

Summary

Brief summary

An important part of therapeutic procedure after caesarean section (cc), which should start in the first days after surgery, is lymphatic drainage (both manual and brushing).
According to the literature, the use of lymphatic drainage in the first days after cc surgery allows to reduce pain and thus may contribute to less fear of patients moving around after surgery, which in turn may contribute to improving mobility and general functioning in everyday life, accelerate recovery after childbirth, while improving lymphatic drainage at the surgical site may contribute to better healing of the postoperative wound and positively affect the future appearance of the scar and abdominal integuments. All the relationships described may affect the well-being of patients. The aim of the study will be to assess the impact of lymphatic drainage of abdominal wall and brushing in the first days after cesarean section on the appearance of the scar (POSASS and VSS questionnaires) and the psychophysical condition of patients ( SF-36 questionnaires and the Beck Depression Scale).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Malgorzata Chochowska

Address

Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski

Country

Poland

Phone

+48570950823

Fax

chochowska.malgorzata@gmail.com

Contact person for public queries

Name

Anita Kulik

Address

Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski

Country

Poland

Phone

+48957279222

Fax

a.kulik@awf-gorzow.edu.pl

Contact person for scientific queries

Name

Anita Kulik

Address

Zamiejscowy Wydzial Kultury Fizycznej
w Gorzowie Wielkopolskim
Akademii Wychowania Fizycznego
im. Eugeniusza Piaseckiego w Poznaniu
ul. Estkowskiego 13
66-400 Gorzów Wielkopolski

Country

Poland

Phone

+48957279222

Fax

a.kulik@awf-gorzow.edu.pl

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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