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Effectiveness of face to face physiotherapy training and education for women who are undergoing elective Cesarean section. A Randomized Controlled Trial

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SLCTR Registration Number

SLCTR/2019/029


Date of Registration

06 Sep 2019

The date of last modification

Oct 14, 2019



Application Summary


Scientific Title of Trial

Effectiveness of face to face physiotherapy training and education for women who are undergoing elective Cesarean section. A Randomized Controlled Trial


Public Title of Trial

Effectiveness of face to face physiotherapy training and education for women who are undergoing elective Cesarean section in minimizing the post-operative complications following Cesarean section. A Randomized controlled trial


Disease or Health Condition(s) Studied

Complications following elective Cesarean Section


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1234-1896


Any other number(s) assigned to the trial and issuing authority

UCP-AL-15-319: ERC Colombo


Trial Details


What is the research question being addressed?

Could face to face physiotherapy training and education for women who are undergoing elective C- section minimize the post-operative outcomes?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used : Participants


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Not Applicable


Intervention(s) planned

*Study setting - De Soysa Maternity Hospital for Women, Colombo

*Randomization method and procedure - Participants will be randomly assigned in to two groups as intervention group and control group, using the stratified block randomization procedure, with opaque and sealed envelopes containing group allocation numbers.

Intervention - Ten minutes face to face physiotherapy education will be given only for the intervention group

Face to face physiotherapy education sessions (one session) will be given to the intervention group. They will also be provided with a leaflet containing physiotherapy exercise prescription following C section, with diagrams and specific guidelines for the exercises to be followed during - The 1st 24 hours - From 1st to 7th post-operative day - Week 1 to 2 after discharge - Week 3 and beyond - Week 6 and beyond

(Most of the exercises should be done 10-12 repetitions per session and two sessions per day).

All participants will be operated by the same obstetrician (SB) and lower segment transverse incision technique will be used for the cesarean section

First the power point presentation regarding the importance of physiotherapy following Cesarean Section is delivered by the Principal investigator to the intervention group, prior to the Elective Cesarean Section.

On the same day, leaflets containing the list of physiotherapy exercises that should be followed are handed over to the intervention group.

Patients are asked to carry out physiotherapy exercises from the day of the surgery until 6th week after the surgery and are monitored by the principal investigator during this period.

Standard therapy will be given by the nurse for both intervention and control groups as follows.

For post-operative pain control, first diclofenac sodium will be introduced rectally (100mg × 2 times a day) and then tramadol (50mg ×2 times a day), paracetamol (1g × 4 times a day) and domperidone (10mg × 3 times a day) will be introduced orally for both groups.

If required by the patient, additional analgesics or anti-inflammatory medications will also administered by the nurses, who were blinded to the group assignment.

Patients will be introduced to food according to standard protocol and standard monitoring procedures will be done.

Patients of both groups will be encouraged for early mobilization after delivery such as sitting on the bed after 10 hours, sitting on the chair and then ambulation if they are not hypotensive and uterine bleeding is controlled.

Initially, patients of both groups will be ambulated 10–15 m inside their rooms, and the intensity increased in hours and days.

Patients will be usually discharged within 48–72 h in uncomplicated cases.


Inclusion criteria

• Age between 20 – 40 years

• Women who undergo Uncomplicated Category ‘4’ Cesarean delivery under spinal anesthesia, due to obstetric indications such as repeat cesarean delivery, pelvic abnormalities that preclude engagement, malpresentation of fetus, dystocia and elective CS.

• Patients who are discharged on the post-operative day 3


Exclusion criteria

  • Patients who have undergone two or several C sections or abdominal surgeries previously .

  • Patients who have complicated obstetric problems such as Diabetes Mellitus, Systemic Lupus Erythematosus, connective tissue disorders.

  • Patients on maternal sepsis.

  • Patients on Disease Modifying Anti Rheumatic Drugs (DMARDs) and oral steroids.

  • Patients who cannot be given with physiotherapy interventions.

  • Mentally ill patients.

  • Patients who are in the Intensive Care Unit (ICU).

  • Deliveries with post-operative complications.

  • C- sections with general/ epidural anesthesia and using patient controlled anesthesia.

  • Patients with abdominal hernia.

  • Patients with DRA (Diastasis Rectus abdominis) larger than 2cm.



Primary outcome(s)

1.

The post-operative pain score using the VAS (Visual Analogue Scale for pain assessment).

[

On the day of discharge. Day 3 of the CS

]
2.

Additional requirement of analgesics for the pain relief (apart from routine standard protocol) using the medical records. On the day of discharge

[

On the day of discharge. Day 3 of the CS

]
3.

The length of hospital stay using the medical records. On the day of discharge

[

On the day of discharge. Day 3 of the CS

]
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Secondary outcome(s)

1.

Quality of post-natal life of both groups using Short Form Health Survey tool (SF-36)- Self-administered questionnaire.

[

After 6 weeks of the Cesarian Section.

]

Target number/sample size

54 (27 in an arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2019-09-06


Anticipated end date

2020-04-01


Date of first enrollment

2019-09-06


Date of study completion


Recruitment status

Recruiting


Funding source

Self funded


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-06-14


Approval number

UCP-AL-15-319


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:No 271, Kynsey Road, Colombo 8, Sri Lanka
Telephone:0112695300 ext 240
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Kalani Weerasinghe
University student
No 271, Kynsey Road, Colombo 8, Sri Lanka
0112695300 ext 240
071 9881734
None
kalani.weerasingha549@gmail.com
None

Contact Person for Public Queries

Dr. MRM Rishard
tment of Obstetrics and Gynecology, Faculty of Medicine, University of Colombo
No 271, Kynsey Road, Colombo 8, Sri Lanka
0112695300 ext 240
0773741850
None
rishi7875@yahoo.com
None


Primary study sponsor/organization

BSc. Physiotherapy Degree Programme, Department of Allied Health Sciences, Faculty of Medicine, University of Colombo.





Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Study protocol will be available in addition to the data. Data will be available immediately following publication, no end date. Anyone who wishes to may access the data in order to achieve the aims in an approved proposal.


Study protocol available

Yes


Protocol version and date

Version 1.0


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results