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NCT Number: NCT04363281

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Beilinson hospital

Petach Tikvah, Israel

About this study

This is a prospective, observational study. Following obtaining written formal consent parturients will be requested to fill out the following questionnaires

  • 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoperative questionnaire

Other
  • 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

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.

Primary outcomes

  1. Verbal numeric Score of postoperative pain

    Time frame: 24 hours

    measured by a verbal numeric score from 0-10

  2. Verbal numeric Score of intraoperative pain

    Time frame: 1 hour during surgery

    measured by a verbal numeric score from 0-10

  3. Preoperative Anxiety

    Time frame: 2 hours before surgery

    Score from 0-10

Secondary outcomes

  1. Patient provider perception of pain

    Time frame: 1 hour during surgey

    measured by a verbal numeric score from 0-10

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 27, 2020
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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