Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07437703
Brief 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.
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:
NCT07437703
Study Brief:
Protocol Section:
NCT07437703