Venous Thromboembolism (VTE)NCT07168005
Informative Video Before LMWH Postpartum - Randomized Controlled Trial
A study testing Informative Video on LMWH and Standard Verbal Explanation in people with Venous Thromboembolism (VTE) and Postpartum Care, run by Wolfson Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Venous Thromboembolism (VTE), Postpartum Care, Anxiety
- What is being tested?
- Informative Video on LMWH and Standard Verbal Explanation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Oct 2025to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women 18-45 years, postpartum, indicated for LMWH, Hebrew-literate, gave consent
Who cannot join
- Use of LMWH pre-delivery, IUFD, pregnancy termination, language/cognitive barrier
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Wolfson Medical Center
Holon
Matan Friedman, MD, +972 54-421-0360, matan.friedman@gmail.com
Hagit Eisenberg, MD, +972523397843, hagiteisen@yahoo.com
About this study
Official title: Does an Informative Video Reduce Anxiety and Pain Before LMWH Treatment Postpartum? - A Randomized Controlled 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.
Read the 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.
- Conditions
- Venous Thromboembolism (VTE), Postpartum Care, Anxiety
- Being tested
- Informative Video on LMWH, Standard Verbal Explanation
- 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
- Medical subject headings
- Venous Thromboembolism, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative Video on LMWHBehavioural
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
Standard Verbal ExplanationBehavioural
Participants receive the routine verbal explanation regarding postpartum LMWH (Clexane) administration, covering its purpose and method of injection
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | 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. Receives: Behavioral: Informative Video on LMWH |
| Control Group | Active comparator | 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 Receives: Behavioral: Standard Verbal Explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after intervention and before first LMWH injection
Secondary outcomes (4)
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.
Measured: From baseline (before intervention) to immediately after intervention (within 1 hour postpartum)
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).
Measured: Immediately after the first LMWH injection
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).
Measured: Immediately after the intervention and first injection
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).
Measured: Up to 6 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matan Friedman, MD, Principal investigator, Wolfson Medical CenterAmihai Rottenstreich, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168005
- Sponsor's protocol ID
- 0121-25-WOMC
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22315262Wong 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.
PubMed 39323021Middeldorp S, Ganzevoort W. How I treat venous thromboembolism in pregnancy. Blood. 2020 Nov 5;136(19):2133-2142. doi: 10.1182/blood.2019000963.
PubMed 32797192James 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.
PubMed 17916457Bates 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.
PubMed 30482767
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Informative Video Reduce Anxiety and Pain Before LMWH Treatment Postpartum? - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07168005
- Acronym / sponsor ID
- 0121-25-WOMC
- Conditions
- Venous Thromboembolism (VTE), Postpartum Care, Anxiety
- Keywords
- Postpartum, Venous Thromboembolism, VTE, LMWH, Low Molecular Weight Heparin, Clexane, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: Informative Video on LMWHParticipants 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. |
| Control Group | Active comparator | Behavioral: Standard Verbal ExplanationParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women 18-45 years, postpartum, indicated for LMWH, Hebrew-literate, gave consent
Key exclusion criteria (1 listed)
- Use of LMWH pre-delivery, IUFD, pregnancy termination, language/cognitive barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informative Video on LMWHA 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 | Behavioural | Video |
| Standard Verbal ExplanationParticipants receive the routine verbal explanation regarding postpartum LMWH (Clexane) administration, covering its purpose and method of injection | Behavioural | Control Group |
Primary outcome
Post-intervention Anxiety Level (STAI Score)
Time frame: Immediately after intervention and before first LMWH injection
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.
4 secondary outcomes
Change in Anxiety Level (Δ STAI Score)
Time frame: From baseline (before intervention) to immediately after intervention (within 1 hour postpartum)
Pain and Discomfort During Injection (VAS Score)
Time frame: Immediately after the first LMWH injection
Satisfaction With Explanation Process (VAS Score)
Time frame: Immediately after the intervention and first injection
Adherence to LMWH at Home
Time frame: Up to 6 weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 22315262MacLean 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.
- Background: PubMed 39323021Wong 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.
- Background: PubMed 32797192Middeldorp S, Ganzevoort W. How I treat venous thromboembolism in pregnancy. Blood. 2020 Nov 5;136(19):2133-2142. doi: 10.1182/blood.2019000963.
- Background: PubMed 17916457James 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.
- Background: PubMed 30482767Bates 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matan Friedman, MD principal investigator
Wolfson Medical Center
Amihai Rottenstreich, MD principal investigator
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informative Video on LMWH and Standard Verbal Explanation in people with Venous Thromboembolism (VTE) and Postpartum Care, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matan Friedman, MD (+972 54-421-0360, matan.friedman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention Anxiety Level (STAI Score) (time frame: Immediately after intervention and before first LMWH injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168005, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.