Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07168005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Informative Video Before LMWH Postpartum - Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study. Neither participants nor healthcare providers are blinded to group allocation, as the nature of the intervention (informative video) makes blinding infeasible.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned in a 1:1 ratio to either the intervention group (standard explanation plus a short informative video) or the control group (standard explanation only). Both groups will receive their assigned explanation prior to the first postpartum LMWH (Clexane) injection. Outcomes will be assessed immediately following the intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-intervention Anxiety Level (STAI Score)', 'timeFrame': 'Immediately after intervention and before first LMWH injection', 'description': 'Anxiety will be measured using the State-Trait Anxiety Inventory (STAI) after participants receive either the standard explanation alone or view informative video, and before their first LMWH (Clexane) injection.'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety Level (Δ STAI Score)', 'timeFrame': 'From baseline (before intervention) to immediately after intervention (within 1 hour postpartum)', 'description': 'The difference in State-Trait Anxiety Inventory (STAI) score before and after the intervention (video or standard explanation) will be calculated to assess the change in anxiety levels.'}, {'measure': 'Pain and Discomfort During Injection (VAS Score)', 'timeFrame': 'Immediately after the first LMWH injection', 'description': 'Pain and discomfort will be assessed immediately after the first LMWH (Clexane) injection using an 11-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Satisfaction With Explanation Process (VAS Score)', 'timeFrame': 'Immediately after the intervention and first injection', 'description': 'Participants will rate their satisfaction with the explanation process (standard verbal vs. video-enhanced) using an 11-point Visual Analog Scale (VAS), ranging from 0 (not satisfied at all) to 10 (very satisfied).'}, {'measure': 'Adherence to LMWH at Home', 'timeFrame': 'Up to 6 weeks post-discharge', 'description': 'Among participants discharged with instructions for continued LMWH use, adherence will be assessed via structured telephone follow-up (self-reported number of injections taken vs. prescribed).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum', 'Venous Thromboembolism', 'VTE', 'LMWH', 'Low Molecular Weight Heparin', 'Clexane', 'Anxiety', 'Pain', 'Patient Education', 'Informative Video', 'State-Trait Anxiety Inventory', 'STAI', 'Postpartum Care', 'Women's Health', 'Obstetrics', 'Adherence'], 'conditions': ['Venous Thromboembolism (VTE)', 'Postpartum Care', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '22315262', 'type': 'BACKGROUND', 'citation': 'MacLean S, Mulla S, Akl EA, Jankowski M, Vandvik PO, Ebrahim S, McLeod S, Bhatnagar N, Guyatt GH. Patient values and preferences in decision making for antithrombotic therapy: a systematic review: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e1S-e23S. doi: 10.1378/chest.11-2290.'}, {'pmid': '39323021', 'type': 'BACKGROUND', 'citation': 'Wong AKC, Chu RYK, Nan Y, Cheng H, Tong D, Leung M, Lam H, Chiu SH, Cheung HW, Chan MC, Chau MY, Lee T, Leung YW, Mow HC, Wan S, Wong LY, Montarye J. Injection Techniques to Reduce Adverse Effects of Subcutaneous Low-Molecular-Weight Heparin Among Patients With Cardiovascular Diseases: A Scoping Review. J Adv Nurs. 2025 Nov;81(11):7361-7373. doi: 10.1111/jan.16475. Epub 2024 Sep 25.'}, {'pmid': '32797192', 'type': 'BACKGROUND', 'citation': 'Middeldorp S, Ganzevoort W. How I treat venous thromboembolism in pregnancy. Blood. 2020 Nov 5;136(19):2133-2142. doi: 10.1182/blood.2019000963.'}, {'pmid': '17916457', 'type': 'BACKGROUND', 'citation': 'James AH. Prevention and management of venous thromboembolism in pregnancy. Am J Med. 2007 Oct;120(10 Suppl 2):S26-34. doi: 10.1016/j.amjmed.2007.08.011.'}, {'pmid': '30482767', 'type': 'BACKGROUND', 'citation': 'Bates SM, Rajasekhar A, Middeldorp S, McLintock C, Rodger MA, James AH, Vazquez SR, Greer IA, Riva JJ, Bhatt M, Schwab N, Barrett D, LaHaye A, Rochwerg B. American Society of Hematology 2018 guidelines for management of venous thromboembolism: venous thromboembolism in the context of pregnancy. Blood Adv. 2018 Nov 27;2(22):3317-3359. doi: 10.1182/bloodadvances.2018024802.'}]}, 'descriptionModule': {'briefSummary': 'This single-center randomized controlled trial evaluates whether a short informative video can reduce anxiety and pain before the first postpartum administration of low molecular weight heparin (LMWH, Clexane). Eligible women will be randomized to receive either standard explanation alone or standard explanation plus a short educational video. The primary outcome is anxiety level assessed via the State-Trait Anxiety Inventory (STAI). Secondary outcomes include pain, satisfaction, and treatment adherence.', 'detailedDescription': 'Venous thromboembolism (VTE) is a leading cause of maternal morbidity and mortality, with the postpartum period carrying a particularly elevated risk. As part of standard care, low molecular weight heparin (LMWH), typically Clexane, is frequently prescribed postpartum for thromboprophylaxis. However, the initiation of LMWH injections during the early postpartum period may provoke anxiety and discomfort due to heightened pain sensitivity, unfamiliarity with the treatment, and emotional vulnerability.\n\nWhile informative videos have been shown to reduce patient anxiety and increase procedural satisfaction in various medical contexts, no studies have explored their use in the postpartum setting specifically for LMWH initiation. This study aims to determine whether a brief educational video shown to women prior to their first LMWH injection postpartum can reduce anxiety and pain, improve satisfaction, and potentially enhance adherence to treatment.\n\nThis is a prospective, single-center randomized controlled trial conducted at Edith Wolfson Medical Center. Women aged 18-45 who delivered at the hospital and are indicated for LMWH will be recruited and randomized in a 1:1 ratio into two groups. The control group will receive the standard verbal explanation from nursing staff regarding LMWH administration. The intervention group will receive the same standard explanation, followed by a short (up to 5 minutes) educational video explaining the rationale, process, and safety of LMWH therapy in the postpartum period.\n\nThe primary outcome is the anxiety level measured using the State-Trait Anxiety Inventory (STAI) after receiving the explanation or video and before the first LMWH injection. Secondary outcomes include the change in anxiety (ΔSTAI) before and after the intervention, pain and discomfort measured by an 11-point Visual Analog Scale (VAS), satisfaction with the explanation process, and adherence to LMWH treatment post-discharge as assessed via telephone follow-up.\n\nThe study will enroll 160 participants to account for an estimated 30% dropout rate, based on a calculated sample size of 126 participants needed to detect a clinically significant 5-point difference in STAI scores (power 80%, α = 0.05). Randomization will be performed using sealed envelopes. Blinding is not applicable. Data will be collected via structured questionnaires administered before and after the intervention, with follow-up data obtained via phone contact for those discharged with ongoing LMWH therapy.\n\nEthical approval will be obtained from the institutional review board prior to recruitment. Participation is voluntary, and informed consent will be obtained from all participants. All data will be anonymized and stored securely on password-protected hospital servers. No biological samples will be collected.\n\nThis study seeks to provide evidence on the role of simple digital educational tools in improving the postpartum care experience and reducing patient distress during routine pharmacologic interventions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWomen 18-45 years, postpartum, indicated for LMWH, Hebrew-literate, gave consent\n\nExclusion Criteria:\n\nUse of LMWH pre-delivery, IUFD, pregnancy termination, language/cognitive barrier'}, 'identificationModule': {'nctId': 'NCT07168005', 'briefTitle': 'Informative Video Before LMWH Postpartum - Randomized Controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Does an Informative Video Reduce Anxiety and Pain Before LMWH Treatment Postpartum? - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0121-25-WOMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video', 'description': 'Participants in this group will view a short (up to 5 minutes) informative video. The video explains the rationale, procedure, and safety of LMWH to reduce anxiety and increase patient understanding prior to the first injection.', 'interventionNames': ['Behavioral: Informative Video on LMWH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in this group will receive only a verbal explanation regarding postpartum LMWH (Clexane) administration, without any additional video intervention. This represents the current standard of care', 'interventionNames': ['Behavioral: Standard Verbal Explanation']}], 'interventions': [{'name': 'Informative Video on LMWH', 'type': 'BEHAVIORAL', 'description': 'A short (up to 5 minutes) informative video presented to postpartum women prior to their first LMWH (Clexane) injection. The video explains the rationale, process, and safety of LMWH use for thrombopr', 'armGroupLabels': ['Video']}, {'name': 'Standard Verbal Explanation', 'type': 'BEHAVIORAL', 'description': 'Participants receive the routine verbal explanation regarding postpartum LMWH (Clexane) administration, covering its purpose and method of injection', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'country': 'Israel', 'contacts': [{'name': 'Matan Friedman, MD', 'role': 'CONTACT', 'email': 'matan.friedman@gmail.com', 'phone': '+972 54-421-0360'}, {'name': 'Hagit Eisenberg, MD', 'role': 'CONTACT', 'email': 'hagiteisen@yahoo.com', 'phone': '+972523397843'}, {'name': 'Matan Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amihai Rottenstreich, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'Matan Friedman, MD', 'role': 'CONTACT', 'email': 'matan.friedman@gmail.com', 'phone': '+972 54-421-0360'}, {'name': 'Amihai Rottenstreich, MD', 'role': 'CONTACT', 'email': 'amichaimd@gmail.com', 'phone': '+972 50-688-4171'}], 'overallOfficials': [{'name': 'Matan Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}, {'name': 'Amihai Rottenstreich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wolfson Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Start Date: 6 months after publication of the primary results. End Date: 5 years after publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) to be shared will include baseline demographics, STAI scores (pre- and post-intervention), Visual Analog Scale (VAS) scores for pain and satisfaction, and adherence data collected during follow-up. No personally identifying information will be included.', 'accessCriteria': 'De-identified individual participant data (IPD) and supporting documents (study protocol, statistical analysis plan, informed consent form) will be made available to qualified researchers affiliated with academic or healthcare institutions. Access will be granted upon reasonable request, subject to approval by the principal investigator and the Edith Wolfson Medical Center institutional review board. Approved data will be shared through a secure institutional file transfer system.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}