Clinical trial NCT04363281: The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception
Official title: The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception : A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 193
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients will be approached and consented for participation in the women's surgery unit on the day of surgery when they aren't under any pain or sedatives.

Brief summary: In this study we will assess the incidence and severity of intraoperative and postoperative pain and determine the effect of preoperative anxiety on intraoperative and postoperative pain incidence. Secondary outcome is to assess provider perception of pain.

Detailed description: This is a prospective, observational study. Following obtaining written formal consent parturients will be requested to fill out the following questionnaires

1. Three questions to predict acute pain:

   * Verbal numeric score Anxiety 0-10
   * Anticipated postoperative pain level
   * Anticipated analgesic requirements
2. Speilberger STATE-TRATE inventory index
3. Pain Catastrophizing Scale In the post anesthesia care unit (PACU) parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea. Furthermore parturients will also be approached at 12 hours and 48 hours postpartum and questioned regarding anxiety levels and medication consumption and requested to fill out the OBSQOR 11 questionnaire at 12 hours postpartum.

Additionally, both the attending anesthesiologist and obstetrician will be questioned regarding the parturient's level of intraoperative pain, postoperative pain levels anxiety medication consumption, uteronic management, surgical technique and management.

Eligibility criteria: Inclusion Criteria:

\*Women undergoing an elective cesarean section under spinal anesthesia with the ability to comply with the study requirements will be eligible for participation

Exclusion Criteria:

* All women unable to receive spinal anesthesia or with inadequate spinal anesthesia prior to the beginning of surgery (Less than T4 Sensory Level to pinprick assessed from blunt tip needle in caudal to cranial direction )
* All women receiving antianxiety medication
* Language barrier

Primary outcomes:
measure: Verbal numeric Score of postoperative pain
timeFrame: 24 hours
measure: Verbal numeric Score of intraoperative pain
timeFrame: 1 hour during surgery
measure: Preoperative Anxiety
timeFrame: 2 hours before surgery
Secondary outcomes:
measure: Patient provider perception of pain
timeFrame: 1 hour during surgey
Other outcomes:
Locations:
city: Petach tikvah
country: Israel
facility: Beilinson hospital
Study officials:
References:
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citation: Gorkem U, Togrul C, Sahiner Y, Yazla E, Gungor T. Preoperative anxiety may increase postcesarean delivery pain and analgesic consumption. Minerva Anestesiol. 2016 Sep;82(9):974-80. Epub 2016 Mar 30.
citation: Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.
citation: McCombe K, Bogod DG. Learning from the Law. A review of 21 years of litigation for pain during caesarean section. Anaesthesia. 2018 Feb;73(2):223-230. doi: 10.1111/anae.14119. Epub 2017 Nov 1.