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NCT04363281 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04363281
Other study ID # 409-19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 25, 2020
Est. completion date February 1, 2021

Study information
Verified date December 2021
Source Rabin Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 193
Est. completion date February 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• preoperative questionnaire
Three questions to predict acute pain: Verbal numeric score Anxiety 0-10 Anticipated postoperative pain level Anticipated analgesic requirements Speilberger STATE-TRATE inventory index Pain Catastrophizing Scale
• PACU questionnaire
parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea.
• Postoperative questionnaire
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
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
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.

Locations
Country Name City State
Israel Beilinson hospital Petach tikvah

Sponsors (1)
Lead Sponsor Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

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. — View Citation

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. — View 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. — View Citation

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. Review. — View 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. — View 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Verbal numeric Score of postoperative pain measured by a verbal numeric score from 0-10 24 hours
Primary Verbal numeric Score of intraoperative pain measured by a verbal numeric score from 0-10 1 hour during surgery
Primary Preoperative Anxiety Score from 0-10 2 hours before surgery
Secondary Patient provider perception of pain measured by a verbal numeric score from 0-10 1 hour during surgey
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