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

NCT04363281 | Completed

• 1 other identifier: 409-19
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Verbal numeric Score of postoperative pain

  measured by a verbal numeric score from 0-10

  24 hours

• Verbal numeric Score of intraoperative pain

  measured by a verbal numeric score from 0-10

  1 hour during surgery

• Preoperative Anxiety

  Score from 0-10

  2 hours before surgery

Secondary Outcomes (1)

• Patient provider perception of pain

  1 hour during surgey

Interventions

preoperative questionnaire OTHER

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

PACU questionnaire OTHER

parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea.

Postoperative questionnaire OTHER

Parturients will be approached at 24 hours postpartum and questioned regarding anxiety levels and medication consumption and requested to fill out the OBSQOR 11 questionnaire at 24 hours postpartum.

Postoperative questionnaire- Obstetrician OTHER

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

Postoperative questionnaire- anesthesiologist OTHER

he attended anesthesiologist 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

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Beilinson hospital

Petach Tikvah, Israel

Location

Related Publications (7)

• Bierke S, Petersen W. Influence of anxiety and pain catastrophizing on the course of pain within the first year after uncomplicated total knee replacement: a prospective study. Arch Orthop Trauma Surg. 2017 Dec;137(12):1735-1742. doi: 10.1007/s00402-017-2797-5. Epub 2017 Sep 30.

  PMID: 28965133 BACKGROUND

• Raichle KA, Osborne TL, Jensen MP, Ehde DM, Smith DG, Robinson LR. Preoperative state anxiety, acute postoperative pain, and analgesic use in persons undergoing lower limb amputation. Clin J Pain. 2015 Aug;31(8):699-706. doi: 10.1097/AJP.0000000000000150.

  PMID: 26153780 BACKGROUND

• Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.

  PMID: 26499321 BACKGROUND

• Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.

  PMID: 19672167 BACKGROUND

• 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.

  PMID: 27028449 BACKGROUND

• 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.

  PMID: 23485992 BACKGROUND

• 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.

  PMID: 29090735 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Sharon Orbach-Zinger

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: April 27, 2020
• Study Start: February 25, 2020
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

IL (1)