Pain Relief Satisfaction With New Educational Materials

August 22, 2024 updated by: Kathleen Reyes, University of New Mexico

Satisfaction of Pain Relief During Labor and Delivery Following Access to New Educational Materials

This study compares patient satisfaction after labor and delivery with access to either the default educational materials available, or to a table computer set to display an educational website, thepainlesspush.com.

Study Overview

Detailed Description

This is a prospective randomized controlled study. The investigators hypothesize that parturients with access to the website will exhibit greater satisfaction with labor and delivery pain control.

Potential participants will be recruited from the University of New Mexico Hospital (UNMH) Labor & Delivery floor. Patients will be enrolled following an oral consent process. They will be randomized into either control group or intervention group. Control group participants will have their standard of care visit with an anesthesiologist and routine hospital pain-relief information. Intervention group participants will have their standard of care visit with an anesthesiologist, plus one hour in which to view the patient education website thepainlesspush.com, on an iPad provided by the Anesthesiology department for this purpose. After their delivery and transfer to the mother/baby unit, participants will complete a satisfaction survey brought to them by a study team member. Participants will complete the survey following their delivery and prior to discharge. The primary team will notify us with expected discharge in which we will retrieve the survey from them in their room and answer any last questions. Their active participation in the study will be complete at this time. After a participant completes the satisfaction survey, research team members will collect demographic information and relevant obstetric/medical history information from the electronic medical record.

Study Type

Interventional

Enrollment (Actual)

106

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

    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Hospital

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

Description

Inclusion Criteria:

  • All English- or Spanish-speaking patients who are admitted to UNMH Labor and Delivery for planned progression to active labor.

Exclusion Criteria:

  • Age under 18 years
  • Patients unable to provide consent for medical procedures
  • Patients who do not speak either English or Spanish

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Baseline Group
Access to existing educational materials about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to routine pain-control information
Experimental: Website Group
Access to a tablet computer set to display an educational website (thepainlesspush.com) with information about labor/delivery pain relief options, as well as an opportunity to ask physicians, nurses, and other relevant personnel for more information.
Access to informational website: thepainlesspush.com

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction With Pain Control in Labor
Time Frame: Following delivery and prior to discharge, up to two days
Satisfaction as measured by agreement with Likert scale questionnaire item "I was satisfied with my choice for pain control in labor" where 1 = strongly disagree, 3 = neither agree nor disagree, and 5 = strongly agree. High scores indicate high satisfaction.
Following delivery and prior to discharge, up to two days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidural Analgesia Utilization Rate
Time Frame: On day of delivery
Number of patients receiving epidural analgesia
On day of delivery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kathleen Reyes, MD, University of New Mexico Health Sciences Center

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)

October 1, 2018

Primary Completion (Actual)

April 9, 2020

Study Completion (Actual)

April 9, 2020

Study Registration Dates

First Submitted

October 3, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 18-642

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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