Home » Trials » SLCTR/2019/029
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
The date of last modification
Sep 15, 2020
Trial Status
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
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
Complete: follow up complete
Funding source
Self funded
Regulatory approvals
Not applicable
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 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
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
Yes
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
Mean post-operative pain score and mean doses of additional analgesics required were significantly higher in control group compared to that of the intervention group (p < 0.05). Pain and difficulty in functional activities decreased significantly within 2 days in both groups, and the values were lower in the intervention group (p < 0.05). Intervention group showed a comparatively lesser length of hospital stay and higher quality of post natal life than that of the control group (p < 0.05).