Improving Pain Perceptions After Initiating a Delivery Application

NCT04822493 | Completed DMC

• 1 other identifier: Pro00099027
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain; Pain

Keywords

Pain perception; Postpartum; Counseling aid; ERAS; Postpartum pain; Pain expectations

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (4)

• Medication at discharge

  1 year

• Narcotic use

  1 year

• Effects of pain on recovery

  1 year

• Pain and mood

  1 year

Study Arms (2)

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.

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.

Interventions

Counseling Aid OTHER

Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.

Counseling Aid

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English or Non-Spanish speaking patients
• Inability to read English, inability to read Spanish
• Pregnancy diagnosed with fetal anomalies
• Intrauterine fetal demise

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

Location

Related Publications (11)

• 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.

  PMID: 28097305 BACKGROUND

• Bisch 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.

  PMID: 30100053 BACKGROUND

• Scheib 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.

  PMID: 30580100 BACKGROUND

• Fay 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.

  PMID: 31238038 BACKGROUND

• Hedderson 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.

  PMID: 31403591 BACKGROUND

• Wilson 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.

  PMID: 30240657 BACKGROUND

• Caughey 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.

  PMID: 30118692 BACKGROUND

• Macones 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.

  PMID: 30995461 BACKGROUND

• Chou 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.

  PMID: 26827847 BACKGROUND

• Peerdeman 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.

  PMID: 26945235 BACKGROUND

• Bialosky 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.

  PMID: 20592270 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Creighton Likes, MD

  Prisma Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: March 30, 2021
• Study Start: January 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)