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:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT07168005
Brief Summary:
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.
Detailed Description:
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.
While 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.
This 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.
The 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.
The 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.
Ethical 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.
This 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.
Study:
NCT07168005
Study Brief:
Protocol Section:
NCT07168005