A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia (PrepDM)

April 14, 2026 updated by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

A Randomized Controlled Trial of a Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia

Labour analgesia decisions are often made under time pressure, while in pain, which may lead patients to feel unprepared or uninformed. Shared decision-making (SDM) enhances patient satisfaction, promotes alignment with personal values, and improves trust in clinical care. Digital tools can support SDM by providing accessible, evidence-based information.

The Society for Obstetric Anesthesia and Perinatology (SOAP) is an international organization made up of doctors who specialize in managing pain and anesthesia during pregnancy. Their focus is the wellbeing and safety of mothers and their babies from early pregnancy through delivery and recovery. The Painless Push digital resource educates mothers about ways to manage pain during labour.

This trial aims to evaluate whether directing patients to access to the website https://thepainlesspush.com/ improves preparedness for shared decision-making compared to the current care, which is access to the Mount Sinai Obstetric Anesthesia website.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X5
        • Mount Sinai Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sanaz Bayani, MD

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant individuals ≥ 18 years
  • Visiting OB clinic at Mount Sinai hospital during their 3rd trimester of pregnancy (≥ 28 weeks gestation)
  • Singleton gestation
  • Nulliparous
  • Considering labour epidural analgesia for childbirth

Exclusion Criteria:

  • Sensory, cognitive, or language barriers precluding participation
  • Limited English proficiency

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Society for Obstetric Anesthesia and Perinatology (SOAP) Painless push website
Comparator: The Painless Push digital resource educates mothers about ways to manage pain during labour.
Other: Preparation for Decision Making (PrepDM) Scale
Electronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100.
Other: Questionnaire
Electronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale.
Other: Mount Sinai Obstetric Anesthesia website
Control group: website currently available to patients.
Other: Preparation for Decision Making (PrepDM) Scale
Electronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100.
Other: Questionnaire
Electronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preparation for Decision Making (PrepDM) score
Time Frame: Immediately following intervention (reading material)
PrepDM is a 10-item validated tool scored from 0 to 100. Higher scores reflect greater readiness for informed and shared decision-making
Immediately following intervention (reading material)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire - additional questions about digital material provided
Time Frame: Immediately following intervention (reading material)
Additional questions about the clarity of the information, perceived understanding, likelihood of recommending, and intent to engage in shared decision-making in future health decisions.
Immediately following intervention (reading material)

Collaborators and Investigators

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

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Investigators

  • Principal Investigator: Ronald George, MD, Mount Sinai Hospital

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-01

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.

Clinical Trials on Labour Analgesia

Clinical Trials on Preparation for Decision Making (PrepDM) Scale

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe