Informative Video Before LMWH Postpartum - Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorWolfson Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Informative Video on LMWH
BehavioralA 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
Standard Verbal Explanation
BehavioralParticipants receive the routine verbal explanation regarding postpartum LMWH (Clexane) administration, covering its purpose and method of injection
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: VideoExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Post-intervention Anxiety Level (STAI Score)
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.
Time frame
Immediately after intervention and before first LMWH injectionSecondary outcomes
1
Change in Anxiety Level (Δ STAI Score)
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.
Time frame
From baseline (before intervention) to immediately after intervention (within 1 hour postpartum)2
Pain and Discomfort During Injection (VAS Score)
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).
Time frame
Immediately after the first LMWH injection3
Satisfaction With Explanation Process (VAS Score)
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).
Time frame
Immediately after the intervention and first injection4
Adherence to LMWH at Home
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).
Time frame
Up to 6 weeks post-dischargeSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: