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Not yet recruiting NCT07516171

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

No phase Interventional Labour Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preparation for Decision Making (PrepDM) Scale, Questionnaire.
Who it may be relevant to
Registry conditions: Labour Analgesia. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Preparation for Decision Making (PrepDM) score [Time frame: Immediately following intervention (reading material)]
Secondary outcome measures (1)
  • Questionnaire - additional questions about digital material provided [Time frame: Immediately following intervention (reading material)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Mount Sinai Hospital — Toronto

Identifiers

NCT: NCT07516171 · 26-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗