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Pain Relief Satisfaction With New Educational Materials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698773
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kathleen Reyes, University of New Mexico

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patient Satisfaction Other: Access to routine information Other: Access to website Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Satisfaction of Pain Relief During Labor and Delivery Following Access to New Educational Materials
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : April 9, 2020
Actual Study Completion Date : April 9, 2020
Arms and Interventions
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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.
 Other: Access to routine 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.
 Other: Access to website
Access to informational website: thepainlesspush.com


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction with pain control in labor [ Time Frame: Up to two days ]
    Satisfaction as measured on 10-item Likert scale questionnaire


Secondary Outcome Measures :
  1. Epidural analgesia utilization rate [ Time Frame: Up to two days ]
    Proportion of patients receiving epidural analgesia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698773


Locations
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United States, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
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Principal Investigator: Kathleen Reyes, MD University of New Mexico Health Sciences Center
More Information
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Responsible Party: Kathleen Reyes, Assistant Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT03698773    
Other Study ID Numbers: 18-642
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No