CClinicalTrials.gg
Not yet recruitingNCT07437703LOVEUpdated Feb 27, 2026

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

An interventional study of Pamphlet and Video in Labour Pain, sponsored by Fraser Health. Not yet recruiting. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Fraser Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years and older
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Labour Pain

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Keywords

  • Labour pain
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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 100 is close to the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

Fraser Health is the lead sponsor of 36 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Emergency delivery/already in labour
  • Patients who are not intending to labour
  • Unable to give consent
  • Unable to communicate in English
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Pamphlet

    A pamphlet about labour pain relief options produced by BC Women's Hospital and published on their website

    Behavioral: Pamphlet

  • Experimental
    Video

    A video about labour pain relief options produced by Royal Columbian Hospital anesthesiologists

    Behavioral: Video

Interventions

  • BehavioralPamphlet

    Electronic version of pamphlet with comprehensive and up-to-date content on both pharmacologic and non-pharmacologic pain relief options during labour.

  • BehavioralVideo

    An educational video featuring anesthesiologists explaining both pharmacologic and non-pharmacologic pain relief options

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What researchers measure

Primary outcomes

  1. Change in fear of birth (FOB)

    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.

    Time frame: From enrollment to end of post-intervention questionnaire (same day)

Secondary outcomes

  1. Change in fear and worry scores

    Time frame: From enrollment to end of post-intervention questionnaire (same day)

  2. Changes in knowledge about pain relief options

    Time frame: From enrollment to end of post-intervention questionnaire (same day)

  3. Birth satisfaction

    Time frame: From enrollment to end of follow-up (2 weeks post estimated delivery date)

  4. Type of analgesia used during labour

    Time frame: From enrollment to end of follow-up (2 weeks post estimated delivery date)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07437703
Lead sponsor
Fraser Health
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Susan M Lee, MD
Contact
susanlee.anesthesia@gmail.com
778-712-3221
Michelle Mozel, MSc
Contact
michelle.mozel@fraserhealth.ca
604-724-2697

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 Feb 2026. You cannot join it, but the record below documents what was studied.

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