Anxiety, Pain, Postoperative Pain
Conditions
Keywords
Preoperative somatic questions, Preoperative audio tone evaluations, Preoperative anxiety and previous experience with postop pain
Brief 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.
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.
Interventions
None listed
Sponsors
Wake Forest University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* ASA \>3 * \< 36 weeks for Cesarean Section * \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evoked Pain at 24 Hours VAS | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anticipated Pain Medication Requirement | 24 hours | measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required |
| Anticipated Postoperative Pain at Preoperative Evaluation | anticipated postoperative pain | anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable |
| Anxiety | anticipated anxiety prior to surgery | measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious |
Countries
United States
Participant flow
Recruitment details
200 Elective cesarean sections and 100 gynecological patients were enrolled prior to their surgery with presurgical testing completed. All subjects were then also seen postoperatively for followup
Pre-assignment details
no randomization, only observational study
Participants by arm
| Arm | Count |
|---|---|
| 1-elective Cesarean Sections Elective Cesarean Sections-this portion completed | 192 |
| 3-inpatient Gynecologic Procedures Any in-patient gynecologic procedure- this portion completed | 100 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 8 | 0 |
Baseline characteristics
| Characteristic | 1-elective Cesarean Sections | 3-inpatient Gynecologic Procedures | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 192 Participants | 100 Participants | 292 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 4.8 | 44.5 years STANDARD_DEVIATION 9 | 34.95 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized African American | 44 Participants | 18 Participants | 62 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 140 Participants | 80 Participants | 220 Participants |
| Region of Enrollment United States | 192 Participants | 100 Participants | 292 Participants |
| Sex: Female, Male Female | 192 Participants | 100 Participants | 292 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 192 | 0 / 100 |
| other Total, other adverse events | 0 / 192 | 0 / 100 |
| serious Total, serious adverse events | 0 / 192 | 0 / 100 |
Outcome results
Primary
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
Time frame: evoked pain at 24 hours
Population: evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-elective Cesarean Section | Evoked Pain at 24 Hours VAS | 44 units on a scale | Standard Deviation 26 |
| 3-inpatient Gynecologic Procedures | Evoked Pain at 24 Hours VAS | 49.3 units on a scale | Standard Deviation 30.7 |
p-value: <0.001Spearman Correlation
p-value: <0.001Spearman Correlation
p-value: <0.001Spearman Correlation
p-value: <0.001Spearman Correlation
Secondary
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
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1-elective Cesarean Section | Anticipated Pain Medication Requirement | 3 units on a scale |
| 3-inpatient Gynecologic Procedures | Anticipated Pain Medication Requirement | 3 units on a scale |
Comparison: preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possiblep-value: <0.001Spearman Correlation
Secondary
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
Time frame: anticipated postoperative pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-elective Cesarean Section | Anticipated Postoperative Pain at Preoperative Evaluation | 57 units on a scale | Standard Deviation 26 |
| 3-inpatient Gynecologic Procedures | Anticipated Postoperative Pain at Preoperative Evaluation | 60.8 units on a scale | Standard Deviation 27.2 |
p-value: <0.001Spearman Correlation
Secondary
Anxiety
measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious
Time frame: anticipated anxiety prior to surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1-elective Cesarean Section | Anxiety | 52 units on a scale | Standard Deviation 32 |
| 3-inpatient Gynecologic Procedures | Anxiety | 57.5 units on a scale | Standard Deviation 34.8 |
p-value: <0.001Spearman Correlation