PainNCT04363281
The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception
An observational study of Pain, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- preoperative questionnaire, PACU questionnaire and Postoperative questionnaire
- How many people
- 193 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Feb 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Women undergoing an elective cesarean section under spinal anesthesia with the ability to comply with the study requirements will be eligible for participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception : A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- preoperative questionnaire, PACU questionnaire, Postoperative questionnaire, Postoperative questionnaire- Obstetrician, Postoperative questionnaire- anesthesiologist
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative questionnaireOther
- 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 questionnaireOther
parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea.
Postoperative questionnaireOther
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- ObstetricianOther
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- anesthesiologistOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal numeric Score of postoperative pain
measured by a verbal numeric score from 0-10
Measured: 24 hours
Verbal numeric Score of intraoperative pain
measured by a verbal numeric score from 0-10
Measured: 1 hour during surgery
Preoperative Anxiety
Score from 0-10
Measured: 2 hours before surgery
Secondary outcomes (1)
Patient provider perception of pain
measured by a verbal numeric score from 0-10
Measured: 1 hour during surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start25 Feb 2020
- Primary completion1 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharonorbach, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363281
- Sponsor's protocol ID
- 409-19
- Status last verified
- Dec 2021
- First submitted
- 13 Feb 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28965133Raichle 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.
PubMed 26153780Aouad 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.
PubMed 26499321Ip 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.
PubMed 19672167Gorkem 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.
PubMed 27028449Pan 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.
PubMed 23485992McCombe 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.
PubMed 29090735
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception : A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04363281
- Acronym / sponsor ID
- 409-19
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women undergoing an elective cesarean section under spinal anesthesia with the ability to comply with the study requirements will be eligible for participation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative questionnaire1. 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 | Other | – |
| PACU questionnaireparturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea. | Other | – |
| Postoperative questionnaireParturients 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. | Other | – |
| Postoperative questionnaire- ObstetricianThe 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. | Other | – |
| Postoperative questionnaire- anesthesiologisthe 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. | Other | – |
Primary outcome
Verbal numeric Score of postoperative pain
Time frame: 24 hours
measured by a verbal numeric score from 0-10
Verbal numeric Score of intraoperative pain
Time frame: 1 hour during surgery
measured by a verbal numeric score from 0-10
Preoperative Anxiety
Time frame: 2 hours before surgery
Score from 0-10
1 secondary outcome
Patient provider perception of pain
Time frame: 1 hour during surgey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Background: PubMed 28965133Bierke 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.
- Background: PubMed 26153780Raichle 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.
- Background: PubMed 26499321Aouad 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.
- Background: PubMed 19672167Ip 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.
- Background: PubMed 27028449Gorkem 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.
- Background: PubMed 23485992Pan 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.
- Background: PubMed 29090735McCombe 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal numeric Score of postoperative pain (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04363281, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.