Prisma Health-Upstate
Greenville, South Carolina, 29605, United States
NCT Number: NCT04822493
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Greenville, South Carolina, 29605, United States
A. 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.
B. 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.
C. Study Methodology
1: Group 1:
2: Group 2:
Identification of Potentially Eligible Patients
Study Enrollment
Treatment Allocation
A. Complete the demographic questionnaire, the survey questions, and then complete the counseling aid.
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.
A. Complete the demographic questionnaire and survey questions without watching the educational video.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
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.
Time frame: 1 year
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
Time frame: 1 year
Amount of narcotics used in postpartum period. Charts will be reviewed to determine actual usage of narcotics during admission
Time frame: 1 year
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.
Time frame: 1 year
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.
Prisma Health-Upstate
Other
Acronym: iPANDA
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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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