Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:07 AM
Study NCT ID:
NCT07437703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, an RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fear of birth (FOB)', 'timeFrame': 'From enrollment to end of post-intervention questionnaire (same day)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in fear and worry scores', 'timeFrame': 'From enrollment to end of post-intervention questionnaire (same day)'}, {'measure': 'Changes in knowledge about pain relief options', 'timeFrame': 'From enrollment to end of post-intervention questionnaire (same day)'}, {'measure': 'Birth satisfaction', 'timeFrame': 'From enrollment to end of follow-up (2 weeks post estimated delivery date)'}, {'measure': 'Type of analgesia used during labour', 'timeFrame': 'From enrollment to end of follow-up (2 weeks post estimated delivery date)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Labour pain'], 'conditions': ['Labour Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nThe primary objective is to evaluate whether an educational video can reduce fear of childbirth more effectively than a pamphlet.\n\nPatients 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.', 'detailedDescription': "Study Design\n\nThe 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).\n\nOn 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.\n\nParticipant Selection\n\nParticipants will be recruited during their routine prenatal appointments at antenatal clinics affiliated with this hospital. Every eligible patient will be invited to participate.\n\nInclusion criteria\n\n1. Adults aged 19 years and over\n2. Primiparous patients over 32 weeks of gestation planning to labour\n\nExclusion Criteria\n\n1. Emergency delivery / already in labour\n2. Patients who are not intending to labour (i.e. primary elective cesarean sections)\n3. Unable to give consent\n4. Unable to communicate in English.\n\nRecruitment\n\nRecruitment will occur at prenatal interactions using multiple methods:\n\n* Self-referral via posters and flyers\n* In-person recruitment\n* Clinic staff assistance\n\nRandomization 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.\n\nFollow-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).\n\nSample 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.\n\nAnalysis 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 19 years and over\n* Primiparous patients over 32 weeks of gestation\n* Planning to labour\n\nExclusion Criteria:\n\n* Emergency delivery/already in labour\n* Patients who are not intending to labour\n* Unable to give consent\n* Unable to communicate in English'}, 'identificationModule': {'nctId': 'NCT07437703', 'acronym': 'LOVE', 'briefTitle': 'Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, an RCT', 'organization': {'class': 'OTHER', 'fullName': 'Fraser Health'}, 'officialTitle': 'Labour Pain Relief Options: Video Versus Pamphlet for Easing Fear of Birth and Improving Preparedness in Pregnant Patients, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FHREB 2025154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pamphlet', 'description': "A pamphlet about labour pain relief options produced by BC Women's Hospital and published on their website", 'interventionNames': ['Behavioral: Pamphlet']}, {'type': 'EXPERIMENTAL', 'label': 'Video', 'description': 'A video about labour pain relief options produced by Royal Columbian Hospital anesthesiologists', 'interventionNames': ['Behavioral: Video']}], 'interventions': [{'name': 'Pamphlet', 'type': 'BEHAVIORAL', 'description': 'Electronic version of pamphlet with comprehensive and up-to-date content on both pharmacologic and non-pharmacologic pain relief options during labour.', 'armGroupLabels': ['Pamphlet']}, {'name': 'Video', 'type': 'BEHAVIORAL', 'description': 'An educational video featuring anesthesiologists explaining both pharmacologic and non-pharmacologic pain relief options', 'armGroupLabels': ['Video']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Susan M Lee, MD', 'role': 'CONTACT', 'email': 'susanlee.anesthesia@gmail.com', 'phone': '778-712-3221'}, {'name': 'Michelle Mozel, MSc', 'role': 'CONTACT', 'email': 'michelle.mozel@fraserhealth.ca', 'phone': '604-724-2697'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fraser Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}