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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04363281
Enrollment
193
Registered
2020-04-27
Start date
2020-02-25
Completion date
2021-02-01
Last updated
2021-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

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.

OTHERpreoperative questionnaire

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

OTHERPACU questionnaire

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

OTHERPostoperative 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.

OTHERPostoperative 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.

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Verbal numeric Score of postoperative pain24 hoursmeasured by a verbal numeric score from 0-10
Verbal numeric Score of intraoperative pain1 hour during surgerymeasured by a verbal numeric score from 0-10
Preoperative Anxiety2 hours before surgeryScore from 0-10

Secondary

MeasureTime frameDescription
Patient provider perception of pain1 hour during surgeymeasured by a verbal numeric score from 0-10

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026