Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, an RCT (LOVE)

February 24, 2026 updated by: Fraser Health

Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, a Randomized Controlled Trial

The goal of this clinical trial is to investigate whether a structured educational video improves outcomes related to fear of birth and patient preparedness for pregnant adults who are planning to labour.

The primary objective is to evaluate whether an educational video can reduce fear of childbirth more effectively than a pamphlet.

Patients will complete a baseline questionnaire assessing their knowledge of labour pain relief options and their current fear of childbirth. The control group will be provided an electronic version of a pamphlet while the intervention group will watch an educational video outlining pharmacologic and non-pharmacologic options for labour pain relief. Immediately after the intervention, all participants will complete the same questionnaire to assess changes in fear and knowledge.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design

The study will employ a randomized controlled trial design. Participants will be randomly assigned to one of two parallel arms: (1) a written pamphlet or (2) an intervention (7-minute educational video).

On the study day, all participants will complete a baseline questionnaire assessing their knowledge of labour pain relief options and their current fear of childbirth. Following informed consent, participants in the control group will be provided an electronic version of the pamphlet; those in the intervention group will watch the video. Immediately after the intervention, all participants will complete the same questionnaires to assess changes in fear and knowledge.

Participant Selection

Participants will be recruited during their routine prenatal appointments at antenatal clinics affiliated with this hospital. Every eligible patient will be invited to participate.

Inclusion criteria

  1. Adults aged 19 years and over
  2. Primiparous patients over 32 weeks of gestation planning to labour

Exclusion Criteria

  1. Emergency delivery / already in labour
  2. Patients who are not intending to labour (i.e. primary elective cesarean sections)
  3. Unable to give consent
  4. Unable to communicate in English.

Recruitment

Recruitment will occur at prenatal interactions using multiple methods:

  • Self-referral via posters and flyers
  • In-person recruitment
  • Clinic staff assistance

Randomization Participants will be randomized in a 1:1 ratio to either the intervention group (educational video) or the control group (written pamphlet). Allocation concealment will be preserved by randomizing the allocation table within REDCap, which will remain hidden from study personnel during the randomization process. Group assignment will be revealed only after participants have completed the baseline assessment and have been enrolled in the study.

Follow-up Questionnaires Follow-up will be conducted two weeks after their estimated due date (EDD). If the follow-up questionnaire is incomplete, one email follow-up reminder will be sent 2-weeks later (at 4-weeks post EDD).

Sample Size Calculation The primary outcome of this study is the change in fear of birth, measured using a validated 2-item Visual Analog Scale (VAS), with each item scored from 0 to 100 and averaged. To detect a 10-point difference with 90% power and a two-sided alpha of 0.05, we estimate that a total of 88 participants (44 per group) are needed. To account for an anticipated attrition rate, we plan to recruit a total of 100 participants (50 per group). This sample size will ensure the study is adequately powered to assess the effectiveness of the educational video in reducing fear of birth compared to standard pamphlet-based education.

Analysis Plan All data will be analyzed using Stata 13.1. P<0.05 will be considered significant. Normally distributed continuous and count variables will be compared using paired t-tests. Ordinal/categorical variables will be analyzed with t-tests, and binary categorial variables (yes/no) will be analyzed using Fisher's exact or Chi-Square tests.

Study Type

Interventional

Enrollment (Estimated)

100

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults age 19 years and over
  • Primiparous patients over 32 weeks of gestation
  • Planning to labour

Exclusion Criteria:

  • Emergency delivery/already in labour
  • Patients who are not intending to labour
  • Unable to give consent
  • Unable to communicate in English

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pamphlet
A pamphlet about labour pain relief options produced by BC Women's Hospital and published on their website
Behavioral: Pamphlet
Electronic version of pamphlet with comprehensive and up-to-date content on both pharmacologic and non-pharmacologic pain relief options during labour.
Experimental: Video
A video about labour pain relief options produced by Royal Columbian Hospital anesthesiologists
Behavioral: Video
An educational video featuring anesthesiologists explaining both pharmacologic and non-pharmacologic pain relief options

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fear of birth (FOB)
Time Frame: From enrollment to end of post-intervention questionnaire (same day)
The primary outcome is the change in fear of birth (FOB), as assessed immediately after reviewing the educational material using a two-item visual analog scale. The FOB total score is derived by calculating the average of the two items that assess fear and worry regarding the upcoming birth, each ranging from 0 to 100, with higher scores indicating higher FOB.
From enrollment to end of post-intervention questionnaire (same day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in fear and worry scores
Time Frame: From enrollment to end of post-intervention questionnaire (same day)
From enrollment to end of post-intervention questionnaire (same day)
Changes in knowledge about pain relief options
Time Frame: From enrollment to end of post-intervention questionnaire (same day)
From enrollment to end of post-intervention questionnaire (same day)
Birth satisfaction
Time Frame: From enrollment to end of follow-up (2 weeks post estimated delivery date)
From enrollment to end of follow-up (2 weeks post estimated delivery date)
Type of analgesia used during labour
Time Frame: From enrollment to end of follow-up (2 weeks post estimated delivery date)
From enrollment to end of follow-up (2 weeks post estimated delivery date)

Collaborators and Investigators

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

Sponsor

Fraser Health

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)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHREB 2025154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share anonymized IPD to the extent that it is permitted by institutional privacy agreements, and specifically share with any requesting researcher. No identifying information will be shared. De-intentified data set will be available via Open Science Foundation.

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.

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