CClinicalTrials.gg
Not yet recruitingNCT07516171PrepDMUpdated Apr 17, 2026

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

An interventional study of Preparation for Decision Making (PrepDM) Scale and Questionnaire in Labour Analgesia, sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. Not yet recruiting at 1 site in Canada. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Labour Analgesia

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Keywords

  • labour pain
  • education
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 325 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital is the lead sponsor of 135 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Sensory, cognitive, or language barriers precluding participation
  • Limited English proficiency
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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 · Other: Questionnaire

  • Other
    Mount Sinai Obstetric Anesthesia website

    Control group: website currently available to patients.

    Other: Preparation for Decision Making (PrepDM) Scale · Other: Questionnaire

Interventions

  • OtherPreparation for Decision Making (PrepDM) Scale

    Electronic questionnaire: (PrepDM) Scale, a 10-item validated tool scored from 0 to 100.

  • OtherQuestionnaire

    Electronic questionnaire, to determine clarity and understanding. Scored on 5-point Likert scale.

06

What researchers measure

Primary outcomes

  1. Preparation for Decision Making (PrepDM) score

    PrepDM is a 10-item validated tool scored from 0 to 100. Higher scores reflect greater readiness for informed and shared decision-making

    Time frame: Immediately following intervention (reading material)

Secondary outcomes

  1. Questionnaire - additional questions about digital material provided

    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.

    Time frame: Immediately following intervention (reading material)

07

Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07516171
Lead sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Apr 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 17, 2026

Study contacts

Ronald George, MD
Contact
ron.george@uhn.ca
416-586-4800 ext. 2681
Kristi Downey, MSc
Contact
kristi.downey@uhn.ca
416-586-4800 ext. 2366
Ronald George, MD
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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