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Mechanical massage with an electric massage chair on pain relief after a caesarean birth

The electric massage chair on post caesarean section pain: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50125423
Enrollment
220
Registered
2024-06-21
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women delivering by caesarean section Pregnancy and Childbirth

Interventions

Participants will be randomised to: a) Intervention group
a 30-minute full-body (posterior aspect) session of mechanical massage using an automated electric massage chair OR b) Placebo group
a 30-minute mechanical vibration session using an identical automated electric massage chair The session will be initiated on the day following the caesarean section. Participants are informed that

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. No later than 24 hours after Caesarean 2. Able to mobilise 3. Age 18-40 years old 4. Singleton offspring 5. Any parity 6. =37 weeks gestation age 7. Lower Segment Caesarean Section 8. Suprapubic transverse skin incision 9. BMI <40 kg/m2 10. Regional anaesthesia only for caesarean

Exclusion criteria

Exclusion criteria: 1. Complicated caesarean (severe PPH >1500 ml, bowel or bladder injury, balloon tamponade etc) 2. Neonatal complications (admission, structural anomaly etc) 3. Stillbirth 4. ICU/HDU care 5. Ongoing Patient-Controlled Analgesia (PCA) or regional analgesia

Design outcomes

Primary

MeasureTime frame
Pain measured using the 0-10 Numerical Rating Scale (NRS) (higher score more pain) scores immediately after the massage chair session, then at 1, 2, 4 and 8 hours later

Secondary

MeasureTime frame
1. Participants’ likelihood to recommend their allocated massage chair treatment to a friend measured using a 5-grade Likert scale as reported by participants 8 hours after the massage chair session 2. Additional opiate analgesia measured using data collected from medical charts from intervention to hospital discharge 3. Intervention to hospital discharge interval measured using data collected from medical charts from intervention to hospital discharge 4. Prescribed analgesics at hospital discharge measured using data collected from medical charts from intervention to hospital discharge 5. Bleeding from the transverse suprapubic incision measured using data collected from medical charts at hospital discharge 6. Separation (=5mm) of the transverse suprapubic incision site measured using data collected from medical charts at hospital discharge 7. Estimated vaginal bleeding =500 ml measured using data collected from medical charts from intervention to hospital discharge 8. Repeated measures analysis of the serial pain scores (from primary outcome 0-10 NRS pain score immediately after the massage chair session, then at 1, 2, 4 and 8 hours later)

Countries

Malaysia

Contacts

Public ContactNor Atiqah Mohd Salleh
atiqah.msalleh@ummc.edu.my+60379492059

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026