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NCT Number: NCT07516171

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.

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Key information

Conditions

Labour Analgesia Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preparation for Decision Making (PrepDM) Scale

Other

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

Questionnaire

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristi Downey, MSc

CONTACT

[email protected]

416-586-4800 ext. 2366

Ronald George, MD

CONTACT

[email protected]

416-586-4800 ext. 2681

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Acronym: PrepDM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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