Labour PainLOVENCT07437703
Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, an RCT
A study testing Pamphlet and Video in people with Labour Pain, run by Fraser Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Labour Pain
- What is being tested?
- Pamphlet and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 19 years and over
- Primiparous patients over 32 weeks of gestation
- Planning to labour
Who cannot join
- Emergency delivery/already in labour
- Patients who are not intending to labour
- Unable to give consent
- Unable to communicate in English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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
- Adults aged 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 (i.e. primary elective cesarean sections)
- Unable to give consent
- 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.
- Conditions
- Labour Pain
- Being tested
- Pamphlet, Video
- Keywords
- Labour pain
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamphletBehavioural
Electronic version of pamphlet with comprehensive and up-to-date content on both pharmacologic and non-pharmacologic pain relief options during labour.
VideoBehavioural
An educational video featuring anesthesiologists explaining both pharmacologic and non-pharmacologic pain relief options
| Study group | Role | What they receive |
|---|---|---|
| Pamphlet | Active comparator | A pamphlet about labour pain relief options produced by BC Women's Hospital and published on their website Receives: Behavioral: Pamphlet |
| Video | Experimental | A video about labour pain relief options produced by Royal Columbian Hospital anesthesiologists Receives: Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of post-intervention questionnaire (same day)
Secondary outcomes (4)
Change in fear and worry scores
Measured: From enrollment to end of post-intervention questionnaire (same day)
Changes in knowledge about pain relief options
Measured: From enrollment to end of post-intervention questionnaire (same day)
Birth satisfaction
Measured: From enrollment to end of follow-up (2 weeks post estimated delivery date)
Type of analgesia used during labour
Measured: From enrollment to end of follow-up (2 weeks post estimated delivery date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437703
- Sponsor's protocol ID
- FHREB 2025154
- Acronym
- LOVE
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07437703
- Acronym / sponsor ID
- LOVE / FHREB 2025154
- Conditions
- Labour Pain
- Keywords
- Labour pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Adults aged 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 (i.e. primary elective cesarean sections)
- Unable to give consent
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamphlet | Active comparator | Behavioral: PamphletA pamphlet about labour pain relief options produced by BC Women's Hospital and published on their website |
| Video | Experimental | Behavioral: VideoA video about labour pain relief options produced by Royal Columbian Hospital anesthesiologists |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 19 years and over
- Primiparous patients over 32 weeks of gestation
- Planning to labour
Key exclusion criteria (4 listed)
- Emergency delivery/already in labour
- Patients who are not intending to labour
- Unable to give consent
- Unable to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamphletElectronic version of pamphlet with comprehensive and up-to-date content on both pharmacologic and non-pharmacologic pain relief options during labour. | Behavioural | Pamphlet |
| VideoAn educational video featuring anesthesiologists explaining both pharmacologic and non-pharmacologic pain relief options | Behavioural | Video |
Primary outcome
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.
4 secondary outcomes
Change in fear and worry scores
Time frame: 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)
Birth satisfaction
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Pamphlet and Video in people with Labour Pain, run by Fraser Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan M Lee, MD (778-712-3221, susanlee.anesthesia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fear of birth (FOB) (time frame: From enrollment to end of post-intervention questionnaire (same day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.