Post-operative Emesis and Pain Outcomes After Cesarean Delivery

Active, not recruitingOBSERVATIONAL
Enrollment

595

Participants

Timeline

Start Date

May 24, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Pain, PostoperativeCesarean SectionNausea, PostoperativeVomiting, Postoperative
Interventions
PROCEDURE

Mechanical Temporal Summation assessment

A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.

OTHER

Preoperative pain assessment

"Patients will be asked to rate, using a 0-10mm visual analog scale (VAS), their surgical anxiety level (On a scale of 0-100, with 0 being not anxious at all to 100 being extremely anxious, how anxious are you about your upcoming surgery?), their anticipated pain (On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing after your upcoming surgery?), and using a categorical scale, their anticipated pain medication need (On a scale of 0 to 5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much pain medication do you anticipate needing after your upcoming surgery?)."

OTHER

Questionnaires

Questionnaires including Hospital Anxiety and Depression Scale (HADS), EQ-5D-3L, Edinburgh Postnatal Depression Scale (EPDS), Pain Catastrophizing Scale (PCS), Central Sensitisation Inventory (CSI), pain survey and breastfeeding questionnaire will be administered to the patient.

OTHER

Headspace

The mindfulness exercise mobile application, Headspace, will be downloaded into the patients' mobile devices. Patients will be asked to experience a mindfulness exercise for 10-30 minutes before delivery. HADS and pain score will be asked after the intervention.

Trial Locations (1)

229899

KK Women's and Children's Hospital, Singapore

All Listed Sponsors
lead

KK Women's and Children's Hospital

OTHER_GOV

NCT03645239 - Post-operative Emesis and Pain Outcomes After Cesarean Delivery | Biotech Hunter | Biotech Hunter