AnxietyNCT00638404
Severity Postoperative Pain Prediction
An observational study of Anxiety and Pain, run by Wake Forest University at 1 site in United States.
Trial summary
A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Pain, Postoperative Pain
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Sep 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries
Who may be able to join
- Healthy ASA physical status class 1 or 2
- Aged 18 years or above
- Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections
Who cannot join
- ASA >3
- < 36 weeks for Cesarean Section
- < 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Predicting Severity of Postoperative Pain After Surgery
A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.
Read the detailed description
The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.
Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.
- Conditions
- Anxiety, Pain, Postoperative Pain
- Keywords
- Preoperative somatic questions, Preoperative audio tone evaluations, Preoperative anxiety and previous experience with postop pain
- Medical subject headings
- Anxiety Disorders, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Elective Cesarean Sections-this portion completed | |
| 3 | Any in-patient gynecologic procedure- this portion completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoked Pain at 24 Hours VAS
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
Measured: evoked pain at 24 hours
Secondary outcomes (3)
Anticipated Pain Medication Requirement
measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required
Measured: 24 hours
Anticipated Postoperative Pain at Preoperative Evaluation
anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable
Measured: anticipated postoperative pain
Anxiety
measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious
Measured: anticipated anxiety prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter H. Pan, MSEE, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638404
- Sponsor's protocol ID
- Pain Prediction
- Status last verified
- Aug 2017
- First submitted
- 12 Mar 2008
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Severity of Postoperative Pain After Surgery
- ClinicalTrials.gov ID
- NCT00638404
- Acronym / sponsor ID
- Pain Prediction
- Conditions
- Anxiety, Pain, Postoperative Pain
- Keywords
- Preoperative somatic questions, Preoperative audio tone evaluations, Preoperative anxiety and previous experience with postop pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Mar 2008 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.
Detailed description
The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.
Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Elective Cesarean Sections-this portion completed |
| 3 | – | –Any in-patient gynecologic procedure- this portion completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries
Key inclusion criteria (3 listed)
- Healthy ASA physical status class 1 or 2
- Aged 18 years or above
- Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections
Key exclusion criteria (3 listed)
- ASA >3
- < 36 weeks for Cesarean Section
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evoked Pain at 24 Hours VAS
Time frame: evoked pain at 24 hours
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
3 secondary outcomes
Anticipated Pain Medication Requirement
Time frame: 24 hours
Anticipated Postoperative Pain at Preoperative Evaluation
Time frame: anticipated postoperative pain
Anxiety
Time frame: anticipated anxiety prior to surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter H. Pan, MSEE, MD principal investigator
Wake Forest University Health Sciences
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 Anxiety and Pain, run by Wake Forest University at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 6 Aug 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evoked Pain at 24 Hours VAS (time frame: evoked pain at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2018.