The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception

Completed

• Conditions: Pain

• Registration Number: NCT04363281
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study Start: 2020-02-25
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Primary Completion: 2020-12-01
• Study Completion: 2021-02-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2021-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verbal numeric Score of intraoperative pain	1 hour during surgery	measured by a verbal numeric score from 0-10
Verbal numeric Score of postoperative pain	24 hours	measured by a verbal numeric score from 0-10
Preoperative Anxiety	2 hours before surgery	Score from 0-10

Secondary Outcome Measures

Name	Time	Method
Patient provider perception of pain	1 hour during surgey	measured by a verbal numeric score from 0-10

Trial Locations

Locations (1)

Beilinson hospital; 🇮🇱 Petach tikvah, Israel