NCT03698773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2020

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 24, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

1.5 years

First QC Date

October 3, 2018

Results QC Date

January 7, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction With Pain Control in Labor

    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 Outcomes (1)

  • Epidural Analgesia Utilization Rate

    On day of delivery

Study Arms (2)

Baseline Group

ACTIVE COMPARATOR

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

Website Group

EXPERIMENTAL

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

Interventions

Access to routine pain-control information

Baseline Group

Access to informational website: thepainlesspush.com

Website Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Research Officer
Organization
University of New Mexico Anesthesiology Department

Study Officials

  • Kathleen Reyes, MD

    University of New Mexico Health Sciences Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 9, 2018

Study Start

October 1, 2018

Primary Completion

April 9, 2020

Study Completion

April 9, 2020

Last Updated

August 27, 2024

Results First Posted

June 24, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations