Improving Pain Perceptions After Initiating a Delivery Application (iPANDA)

June 1, 2022 updated by: Prisma Health-Upstate
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Study Design The study is a randomized control trial. Patients will be assigned 1:1 to the study group and control group.
  2. 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.

    3. Procedures:

Identification of Potentially Eligible Patients

  1. 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

  2. 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.
  3. Study fliers advertising the study will also be posted in OB clinics at the OBGYN Center.
  4. Women who are interested in enrollment will be counseled and consented by study personnel at their scheduled appointment.

  5. 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

  6. On day of enrollment, patients will be randomized into the treatment group or the control group using a computer-generated randomization scheme.
  7. 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.
  8. Randomization assignment will not be blinded.
  9. All participants will complete an initial demographic questionnaire immediately following randomization via self- administered assessments within the test application using a mobile tablet.

  10. Subjects allocated to Group 1: will:

    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.

  11. Subjects allocated to Group 2: will:

    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.

  12. Research staff will complete chart reviews to confirm delivery information and other study related data.

4. Outcomes:

  1. 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.
  2. 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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health-Upstate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant women > 18 years of age
  2. Gestational age 35 weeks to 41 weeks
  3. English or Spanish speaking
  4. Plan for vaginal delivery or cesarean delivery at Greenville Memorial Hospital
  5. Singleton or twin gestation

Exclusion Criteria:

  1. Non-English or Non-Spanish speaking patients
  2. Inability to read English, inability to read Spanish
  3. Pregnancy diagnosed with fetal anomalies
  4. Intrauterine fetal demise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Counseling Aid

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
Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
No Intervention: Standard Care

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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication at discharge
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
1 year
Narcotic use
Time Frame: 1 year
Amount of narcotics used in postpartum period. Charts will be reviewed to determine actual usage of narcotics during admission
1 year
Effects of pain on recovery
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.
1 year
Pain and mood
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Creighton Likes, MD, Prisma Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

March 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00099027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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