Skip to main content
Clinical Trials/NCT04363281
NCT04363281
Completed
Not Applicable

The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception : A Prospective Observational Study

Rabin Medical Center1 site in 1 country193 target enrollmentFebruary 25, 2020
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Rabin Medical Center
Enrollment
193
Locations
1
Primary Endpoint
Verbal numeric Score of postoperative pain
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2020
End Date
February 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

sharonorbach

Professor Sharon Orbach-Zinger

Rabin Medical Center

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

Outcomes

Primary Outcomes

Verbal numeric Score of postoperative pain

Time Frame: 24 hours

measured by a verbal numeric score from 0-10

Preoperative Anxiety

Time Frame: 2 hours before surgery

Score from 0-10

Verbal numeric Score of intraoperative pain

Time Frame: 1 hour during surgery

measured by a verbal numeric score from 0-10

Secondary Outcomes

  • Patient provider perception of pain(1 hour during surgey)

Study Sites (1)

Loading locations...

Similar Trials