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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07516171

Acronym

PrepDM

Enrollment

200

Registered

2026-04-07

Start date

2026-04-01

Completion date

2026-12-01

Last updated

2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Analgesia

Keywords

labour pain, education

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

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

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

Design outcomes

Primary

Measure	Time frame	Description
Preparation for Decision Making (PrepDM) score	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

Measure	Time frame	Description
Questionnaire - additional questions about digital material provided	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.

Countries

Canada

Contacts

CONTACTRonald George, MD

ron.george@uhn.ca416-586-4800

CONTACTKristi Downey, MSc

kristi.downey@uhn.ca416-586-4800

PRINCIPAL_INVESTIGATORRonald George, MD

MOUNT SINAI HOSPITAL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026