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Massage by an electric massage chair compared to nitrous oxide gas as first-line pain relief in labour

Electric massage chair compared to nitrous oxide gas as first-line analgesic in nulliparous labour: a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39001643
Enrollment
464
Registered
2024-04-29
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

First-line labour pain relief in nulliparas Pregnancy and Childbirth

Interventions

Participants who have provided informed written consent will be randomised in a 1-to-1 ratio. Randomisation will be effected by opening the lowest numbered sealed opaque envelope available to reveal t
holding the mouthpiece themselves, putting their lips around the flat, white tube, making an air-tight seal, and taking slow deep breaths, starting just as a contraction begins. Once the contraction i

Sponsors

University Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Admitted to the ward for birth (for labour or induction of labour) 2. Planned vaginal delivery 3. Accepts either nitrous oxide or massage chair as first-line labour analgesia 4. Nulliparous (no prior delivery > 20 weeks) 5. Age = 18 years 6. Gestational age of = 37 weeks 7. Singleton pregnancy 8. Cephalic presentation 9. Reassuring fetal heart rate tracing 10. Estimated fetal weight of 2 to 4 kg 11. Requesting labour pain relief

Exclusion criteria

Exclusion criteria: 1. Contraindication or unsuitability for nitrous oxide or massage chair 2. Known major fetal malformations 3. COVID 19 infection or SARS-CoV2 positive

Design outcomes

Primary

MeasureTime frame
1. Additional analgesic in labour (from the medical record) 2. Maternal satisfaction with their allocated first-line pain reliever (by Numerical rating scale [NRS] 0-10, completely dissatisfied to completely satisfied - asked after the delivery)

Secondary

MeasureTime frame
1. Pain score (by NRS 0-10, a higher score denoted greater pain – asked at 30, 60 and 120 minutes) 2. Time from intervention start to time of (from the medical record): 2.1. initiation of other labour analgesia (if any) 2.2. initiation of epidural (if any) 2.3. second stage of labour 2.4. delivery 3. Epidural analgesia during labour (from the medical record) 4. Opiate analgesia during labour (from the medical record) 5. Side effects during labour (asked after delivery) 5.1. Vomiting 5.2. Dizziness 5.3. Drowsiness 5.4. Back pain 5.5. Body pain 5.6. Back bruising 6. Mode of delivery (from the medical record) 7. Indication for operative delivery (from the medical record) 8. Perineal condition after delivery (from the medical record) 9. Estimated delivery blood loss (from the medical record) 10. Fever (from the medical record) 11. Birthweight (from the medical record) 12. Apgar score at (from the medical record) 1 minute and 5 minutes 13. Umbilical cord artery blood (from the medical record): 13.1. pH 13.2. base excess 14. Neonatal admission (from the medical record) 15. Indication for admission (from the medical record) 16. For first-line labour pain relief in the future, I prefer to use (Asked after delivery): -Massage chair OR Nitrous oxide (Gas – Nitrous oxide)

Countries

Malaysia

Contacts

Public ContactTan Peng Chiong
pctan@um.edu.my+60 123052970

Outcome results

None listed

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