Postoperative PainiPANDANCT04822493
Improving Pain Perceptions After Initiating a Delivery Application
A study testing Counseling Aid in people with Postoperative Pain and Pain, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
The investigators of this study have developed a standardized counseling aid using an electronic mobile device to help women learn about what to expect during labor and subsequent vaginal delivery or cesarean delivery, specifically regarding pain expectations. 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
- Postoperative Pain, Pain
- What is being tested?
- Counseling Aid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Aug 2021
- Phase
- Interventional
- 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
Who may be able to join
- Pregnant women > 18 years of age
- Gestational age 35 weeks to 41 weeks
- English or Spanish speaking
- Plan for vaginal delivery or cesarean delivery at Greenville Memorial Hospital
- Singleton or twin gestation
Who cannot join
- Non-English or Non-Spanish speaking patients
- Inability to read English, inability to read Spanish
- Pregnancy diagnosed with fetal anomalies
- Intrauterine fetal demise
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health-Upstate
Greenville, South Carolina, 29605
About this study
The investigators of this study have developed a standardized counseling aid using an electronic mobile device to help women learn about what to expect during labor and subsequent vaginal delivery or cesarean delivery, specifically regarding pain expectations. Half of women will complete the counseling aid and the other half will receive standard counseling and care. The study aims to determine if the counseling aid improves patient satisfaction and perception of pain control.
Read the detailed description
- Objective To compare perception of postpartum pain and patient satisfaction between women who receive routine obstetric care to those who receive routine obstetric care and complete a standardized counseling aid antepartum.
- Background Enhanced Recovery After Surgery (ERAS) is a standardized, evidenced-based method for the perioperative management of surgical patients. ERAS protocols have been well studied in several surgical specialties, including gynecologic oncology and benign gynecology, and have been shown to reduce hospital length of stay and costs without increasing rates of complications or readmission.
The use of ERAS in obstetrics is also growing. Recent studies have shown that an enhanced recovery pathway after cesarean delivery can decrease hospital stay and cost and reduce opioid use. Guidelines have been developed for evidence-based recommendations for preoperative, intraoperative and postoperative phases of care.
An important component of any ERAS protocol is pre-operative counseling. Postoperative pain management starts with counseling prior to surgery. Guidelines suggest that preoperative counseling should include patient-centered education on the options for management of pain. This process also allows an opportunity to engage patients in the decision making process. Previous studies have shown that counseling on pain expectations can improve patient outcomes.
The aim of our study is to develop a standardized antepartum counseling aid and improve postpartum pain perceptions and patient experience.
- Study Methodology
- Study Design The study is a randomized control trial. Patients will be assigned 1:1 to the study group and control group.
- Comparison Groups:
1: Group 1:
- Study Group: Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling. 2: Group 2:
- Control Group: Women will receive standard care and counseling.
- Procedures:
Identification of Potentially Eligible Patients
- Potentially eligible patients will be identified through screening of clinic patients at time of routine prenatal visit at the Prisma Health OBGYN Center between 35 to 41 weeks gestation. Study Enrollment
- Investigators will review charts of women scheduled for routine obstetric appointments and screen for eligibility. Eligible women will be contacted at the time of their prenatal appointment.
- Study fliers advertising the study will also be posted in OB clinics at the OBGYN Center.
- Women who are interested in enrollment will be counseled and consented by study personnel at their scheduled appointment.
- The enrollment process involves a face-to-face interview with one of the study investigators for verification of study eligibility and counseling regarding study procedures as well as potential benefits and risks prior to obtaining written consent. Treatment Allocation
- On day of enrollment, patients will be randomized into the treatment group or the control group using a computer-generated randomization scheme.
- Randomization will be stratified by plan for delivery with plan for vaginal delivery versus plan for cesarean delivery, as content of the educational videos will be geared towards mode of delivery.
- Randomization assignment will not be blinded.
- All participants will complete an initial demographic questionnaire immediately following randomization via self- administered assessments within the test application using a mobile tablet.
- Subjects allocated to Group 1: will:
- Complete the demographic questionnaire, the survey questions, and then complete the counseling aid.
- Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
- Subjects allocated to Group 2: will:
- Complete the demographic questionnaire and survey questions without watching the educational video.
- Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
- Research staff will complete chart reviews to confirm delivery information and other study related data.
- Outcomes:
- Primary: What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectations during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies.
- Secondary outcomes: Perception of pain control intrapartum and postpartum based on postpartum questionnaires, expectations of what type and how much pain medication at time of discharge, use of narcotics postpartum as determined by chart review, pain perceptions in patients with history of mood disorder as determined by questionnaire, pain perceptions in patients with history of substance abuse as determined by questionnaire.
- Conditions
- Postoperative Pain, Pain
- Being tested
- Counseling Aid
- Keywords
- Pain perception, Postpartum, Counseling aid, ERAS, Postpartum pain, Pain expectations
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling AidOther
Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
| Study group | Role | What they receive |
|---|---|---|
| Counseling Aid | Experimental | A. Complete the demographic questionnaire, the survey questions, and then complete the counseling aid. Receive standard counseling as part of routine prenatal care.
B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application. Receives: Other: Counseling Aid |
| Standard Care | No intervention | A. Complete the demographic questionnaire and survey questions without watching the educational video. Receive standard counseling as part of routine prenatal care. B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).
What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectation counseling during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction of pain expectation counseling will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies.
Participants will respond on a scale of 0 to 10. 0 indicating they were extremely dissatisfied and 10 indicating they were extremely satisfied.
Measured: 1 year
Secondary outcomes (4)
Medication at discharge
Expectations of how much pain medication at time of discharge. Patient's will be asked to report what they expect to receive at discharge. Answer will be a multiple choice response. A) Tylenol/Motrin B) Narcotics 3) All of the above D) None of the above
Measured: 1 year
Narcotic use
Amount of narcotics used in postpartum period. Charts will be reviewed to determine actual usage of narcotics during admission
Measured: 1 year
Effects of pain on recovery
Patients will be asked how much their pain interfered with their healing or recovery. Participants will be asked to respond on a scale of 0 to 10 with 0 indicating no interference with daily activities to 10 indicating complete interference.
Measured: 1 year
Pain and mood
Patients will be asked to rate how much their pain affected their mood. Participants will be asked to rate how much their pain affected their mood on a scale of 0 to 10 with 0 indicating not at all and 10 indicating extremely.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators plan to use block randomization with stratification. The randomization schedule will have 1:1 allocation with a fixed block size of 4. To ensure equivalent numbers for planned cesarean and planned vaginal deliveries, patients will be stratified based on expected mode of delivery. Randomization will occur at the time of enrollment. A computer-generated randomization scheme has been developed within the mobile application. When the participant is assigned a study number, the application with randomly assign them to the study or control group, based on the scheme described above.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Creighton Likes, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822493
- Sponsor's protocol ID
- Pro00099027
- Acronym
- iPANDA
- Status last verified
- Jun 2022
- First submitted
- 11 Sep 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Bisch SP, Wells T, Gramlich L, Faris P, Wang X, Tran DT, Thanh NX, Glaze S, Chu P, Ghatage P, Nation J, Capstick V, Steed H, Sabourin J, Nelson G. Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: System-wide implementation and audit leads to improved value and patient outcomes. Gynecol Oncol. 2018 Oct;151(1):117-123. doi: 10.1016/j.ygyno.2018.08.007. Epub 2018 Aug 9.
PubMed 30100053Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
PubMed 30580100Fay EE, Hitti JE, Delgado CM, Savitsky LM, Mills EB, Slater JL, Bollag LA. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019 Oct;221(4):349.e1-349.e9. doi: 10.1016/j.ajog.2019.06.041. Epub 2019 Jun 22.
PubMed 31238038Hedderson M, Lee D, Hunt E, Lee K, Xu F, Mustille A, Galin J, Campbell C, Quesenberry C, Reyes V, Huang M, Nicol B, Paulson S, Liu V. Enhanced Recovery After Surgery to Change Process Measures and Reduce Opioid Use After Cesarean Delivery: A Quality Improvement Initiative. Obstet Gynecol. 2019 Sep;134(3):511-519. doi: 10.1097/AOG.0000000000003406.
PubMed 31403591Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18.
PubMed 30240657Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15.
PubMed 30118692Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14.
PubMed 30995461Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540.
PubMed 26945235Bialosky JE, Bishop MD, Cleland JA. Individual expectation: an overlooked, but pertinent, factor in the treatment of individuals experiencing musculoskeletal pain. Phys Ther. 2010 Sep;90(9):1345-55. doi: 10.2522/ptj.20090306. Epub 2010 Jun 30.
PubMed 20592270
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain Perceptions After Initiating a Delivery Application
- ClinicalTrials.gov ID
- NCT04822493
- Acronym / sponsor ID
- iPANDA / Pro00099027
- Conditions
- Postoperative Pain, Pain
- Keywords
- Pain perception, Postpartum, Counseling aid, ERAS, Postpartum pain, Pain expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 30 Mar 2021 (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.
The investigators of this study have developed a standardized counseling aid using an electronic mobile device to help women learn about what to expect during labor and subsequent vaginal delivery or cesarean delivery, specifically regarding pain expectations. Half of women will complete the counseling aid and the other half will receive standard counseling and care. The study aims to determine if the counseling aid improves patient satisfaction and perception of pain control.
Detailed description
- Objective To compare perception of postpartum pain and patient satisfaction between women who receive routine obstetric care to those who receive routine obstetric care and complete a standardized counseling aid antepartum.
- Background Enhanced Recovery After Surgery (ERAS) is a standardized, evidenced-based method for the perioperative management of surgical patients. ERAS protocols have been well studied in several surgical specialties, including gynecologic oncology and benign gynecology, and have been shown to reduce hospital length of stay and costs without increasing rates of complications or readmission.
The use of ERAS in obstetrics is also growing. Recent studies have shown that an enhanced recovery pathway after cesarean delivery can decrease hospital stay and cost and reduce opioid use. Guidelines have been developed for evidence-based recommendations for preoperative, intraoperative and postoperative phases of care.
An important component of any ERAS protocol is pre-operative counseling. Postoperative pain management starts with counseling prior to surgery. Guidelines suggest that preoperative counseling should include patient-centered education on the options for management of pain. This process also allows an opportunity to engage patients in the decision making process. Previous studies have shown that counseling on pain expectations can improve patient outcomes.
The aim of our study is to develop a standardized antepartum counseling aid and improve postpartum pain perceptions and patient experience.
- Study Methodology
- Study Design The study is a randomized control trial. Patients will be assigned 1:1 to the study group and control group.
- Comparison Groups:
1: Group 1:
- Study Group: Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling. 2: Group 2:
- Control Group: Women will receive standard care and counseling.
- Procedures:
Identification of Potentially Eligible Patients
- Potentially eligible patients will be identified through screening of clinic patients at time of routine prenatal visit at the Prisma Health OBGYN Center between 35 to 41 weeks gestation. Study Enrollment
- Investigators will review charts of women scheduled for routine obstetric appointments and screen for eligibility. Eligible women will be contacted at the time of their prenatal appointment.
- Study fliers advertising the study will also be posted in OB clinics at the OBGYN Center.
- Women who are interested in enrollment will be counseled and consented by study personnel at their scheduled appointment.
- The enrollment process involves a face-to-face interview with one of the study investigators for verification of study eligibility and counseling regarding study procedures as well as potential benefits and risks prior to obtaining written consent. Treatment Allocation
- On day of enrollment, patients will be randomized into the treatment group or the control group using a computer-generated randomization scheme.
- Randomization will be stratified by plan for delivery with plan for vaginal delivery versus plan for cesarean delivery, as content of the educational videos will be geared towards mode of delivery.
- Randomization assignment will not be blinded.
- All participants will complete an initial demographic questionnaire immediately following randomization via self- administered assessments within the test application using a mobile tablet.
- Subjects allocated to Group 1: will:
- Complete the demographic questionnaire, the survey questions, and then complete the counseling aid.
- Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
- Subjects allocated to Group 2: will:
- Complete the demographic questionnaire and survey questions without watching the educational video.
- Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application.
- Research staff will complete chart reviews to confirm delivery information and other study related data.
- Outcomes:
- Primary: What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectations during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies.
- Secondary outcomes: Perception of pain control intrapartum and postpartum based on postpartum questionnaires, expectations of what type and how much pain medication at time of discharge, use of narcotics postpartum as determined by chart review, pain perceptions in patients with history of mood disorder as determined by questionnaire, pain perceptions in patients with history of substance abuse as determined by questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators plan to use block randomization with stratification. The randomization schedule will have 1:1 allocation with a fixed block size of 4. To ensure equivalent numbers for planned cesarean and planned vaginal deliveries, patients will be stratified based on expected mode of delivery. Randomization will occur at the time of enrollment. A computer-generated randomization scheme has been developed within the mobile application. When the participant is assigned a study number, the application with randomly assign them to the study or control group, based on the scheme described above.
| Arm | Type | Receives |
|---|---|---|
| Counseling Aid | Experimental | Other: Counseling AidA. Complete the demographic questionnaire, the survey questions, and then complete the counseling aid. Receive standard counseling as part of routine prenatal care. B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application. |
| Standard Care | No intervention | –A. Complete the demographic questionnaire and survey questions without watching the educational video. Receive standard counseling as part of routine prenatal care. B. Prior to discharge after delivery, study personnel will administer the postpartum questionnaire via a mobile tablet. The questionnaire is programmed into the study application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women > 18 years of age
- Gestational age 35 weeks to 41 weeks
- English or Spanish speaking
- Plan for vaginal delivery or cesarean delivery at Greenville Memorial Hospital
- Singleton or twin gestation
Key exclusion criteria (4 listed)
- Non-English or Non-Spanish speaking patients
- Inability to read English, inability to read Spanish
- Pregnancy diagnosed with fetal anomalies
- Intrauterine fetal demise
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 |
|---|---|---|
| Counseling AidWomen will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling. | Other | Counseling Aid |
Primary outcome
Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).
Time frame: 1 year
What is the impact of a standardized antepartum counseling aid on patient satisfaction with pain expectation counseling during hospital admission for labor and delivery compared to women who do not use the counseling aid and receive routine counseling only? Satisfaction of pain expectation counseling will be measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management QI activities and measures 6 aspects of quality including: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmocological strategies. Participants will respond on a scale of 0 to 10. 0 indicating they were extremely dissatisfied and 10 indicating they were extremely satisfied.
4 secondary outcomes
Medication at discharge
Time frame: 1 year
Narcotic use
Time frame: 1 year
Effects of pain on recovery
Time frame: 1 year
Pain and mood
Time frame: 1 year
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 2 Jun 2022.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 30100053Bisch SP, Wells T, Gramlich L, Faris P, Wang X, Tran DT, Thanh NX, Glaze S, Chu P, Ghatage P, Nation J, Capstick V, Steed H, Sabourin J, Nelson G. Enhanced Recovery After Surgery (ERAS) in gynecologic oncology: System-wide implementation and audit leads to improved value and patient outcomes. Gynecol Oncol. 2018 Oct;151(1):117-123. doi: 10.1016/j.ygyno.2018.08.007. Epub 2018 Aug 9.
- Background: PubMed 30580100Scheib SA, Thomassee M, Kenner JL. Enhanced Recovery after Surgery in Gynecology: A Review of the Literature. J Minim Invasive Gynecol. 2019 Feb;26(2):327-343. doi: 10.1016/j.jmig.2018.12.010. Epub 2018 Dec 20.
- Background: PubMed 31238038Fay EE, Hitti JE, Delgado CM, Savitsky LM, Mills EB, Slater JL, Bollag LA. An enhanced recovery after surgery pathway for cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol. 2019 Oct;221(4):349.e1-349.e9. doi: 10.1016/j.ajog.2019.06.041. Epub 2019 Jun 22.
- Background: PubMed 31403591Hedderson M, Lee D, Hunt E, Lee K, Xu F, Mustille A, Galin J, Campbell C, Quesenberry C, Reyes V, Huang M, Nicol B, Paulson S, Liu V. Enhanced Recovery After Surgery to Change Process Measures and Reduce Opioid Use After Cesarean Delivery: A Quality Improvement Initiative. Obstet Gynecol. 2019 Sep;134(3):511-519. doi: 10.1097/AOG.0000000000003406.
- Background: PubMed 30240657Wilson RD, Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G. Guidelines for Antenatal and Preoperative care in Cesarean Delivery: Enhanced Recovery After Surgery Society Recommendations (Part 1). Am J Obstet Gynecol. 2018 Dec;219(6):523.e1-523.e15. doi: 10.1016/j.ajog.2018.09.015. Epub 2018 Sep 18.
- Background: PubMed 30118692Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15.
- Background: PubMed 30995461Macones GA, Caughey AB, Wood SL, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for postoperative care in cesarean delivery: Enhanced Recovery After Surgery (ERAS) Society recommendations (part 3). Am J Obstet Gynecol. 2019 Sep;221(3):247.e1-247.e9. doi: 10.1016/j.ajog.2019.04.012. Epub 2019 Apr 14.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- Background: PubMed 26945235Peerdeman KJ, van Laarhoven AIM, Keij SM, Vase L, Rovers MM, Peters ML, Evers AWM. Relieving patients' pain with expectation interventions: a meta-analysis. Pain. 2016 Jun;157(6):1179-1191. doi: 10.1097/j.pain.0000000000000540.
- Background: PubMed 20592270Bialosky JE, Bishop MD, Cleland JA. Individual expectation: an overlooked, but pertinent, factor in the treatment of individuals experiencing musculoskeletal pain. Phys Ther. 2010 Sep;90(9):1345-55. doi: 10.2522/ptj.20090306. Epub 2010 Jun 30.
- Individual participant dataSharing planned: No
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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.
Creighton Likes, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling Aid in people with Postoperative Pain and Pain, run by Prisma Health-Upstate 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 5 inclusion and 4 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 2 Jun 2022. 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?
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?
Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R). (time frame: 1 year). 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 NCT04822493, which also lists 11 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 2 Jun 2022.