Sensory Stimuli During Cesarean Delivery
ConditionIntraoperative Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia
About this trial
This study will follow people having a planned cesarean birth with a spinal or combined spinal-epidural anesthetic. The investigators will ask what kinds of sensations participants feel during the operation, how often these happen, and whether any of the sensations feel as unacceptable or too uncomfortable.
Participants will be asked a few short questions at six set times during the surgery. Participants will also complete short questionnaires before surgery and again after birth (up to 6 months) to help us understand mood, stress, and overall wellbeing.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy pregnant patients ≥36 weeks gestational age
ASA Physical Status Class 2-3
Elective cesarean delivery
Age ≥19 years
Disqualifiers
Known history of chronic pain or pain disorders
Currently taking medications with analgesic properties
Known history of neurological conditions that may impair normal sensation
Cesarean delivery requiring epidural top-up or de novo general anesthesia
Trial population
Healthy pregnant patients ≥36 weeks gestational age undergoing elective cesarean delivery under neuraxial anesthesia at BC Women's Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standardized intraoperative and postoperative patient-reported assessments
Other interventionBrief patient self-assessments at six intraoperative time points (questions + VAS + diagram), and postoperative questionnaires (PDI, EPDS, PCL-5) through 6 months postpartum.
Treatment groups
310 Participants
are divided into 1 treatment groupGroup A: Single cohort1 intervention
Trial outcomes
Primary outcomes
1
Incidence of intraoperative sensory stimuli perceived as unacceptable
Proportion of participants who report experiencing any intraoperative sensory stimulus that they subjectively self-report as unacceptable.
Time frame
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.Secondary outcomes
1
Qualitative description of unacceptable sensory stimuli
Thematic categorization of participant responses
Time frame
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.2
Severity of intraoperative sensory stimuli
Sensation intensity rated using a 0-10 visual analog scale (VAS) at each intraoperative assessment time point.
Time frame
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.3
Total intraoperative supplemental IV analgesia received
Total dose(s) of supplemental IV analgesic medications administered intraoperatively, abstracted from the medical record/anesthesia record.
Time frame
From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.4
PTSD symptoms over time
PTSD Checklist for DSM-5 (PCL-5) score measured longitudinally.
Time frame
From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: