Nursing CareNCT07195955
Cold Spray for Pain and Ecchymosis After Anticoagulant Prophylaxis in Orthopedic Surgery
A study testing Cold Spray Application in people with Nursing Care and Cold Application, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Heparin is a widely used anticoagulant for thrombosis prevention, and low molecular weight heparin (LMWH) has become the preferred option due to its higher bioavailability, strong antithrombotic effect, and lower risk of complications. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Care, Cold Application, Pain
- What is being tested?
- Cold Spray Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are:
- 18 years of age or older
- Receiving 1 x 0.4 ml anticoagulant therapy
- Are on the first day of LMWH therapy
- Have no infection, scar tissue, lipodystrophy, or incision at the injection site
- Have not received any other parenteral therapy at the injection site
- Are not allergic to cold or heparin
- Volunteer to participate in the study
Who cannot join
- Patients were excluded from the study if they were: • Pregnant, • Had any acute or chronic coagulation disorder or hematological disease,
- Had a subcutaneous injection into the same area 24 hours prior,
- Wanted to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Spray Application in Reducing Pain and Ecchymosis in Patients Receiving Low Molecular Weight Heparin Prophylaxis After Orthopedic Surgery
Heparin is a widely used anticoagulant for thrombosis prevention, and low molecular weight heparin (LMWH) has become the preferred option due to its higher bioavailability, strong antithrombotic effect, and lower risk of complications. However, subcutaneous LMWH injections-commonly administered in the abdomen, arm, or thigh-often cause local side effects such as pain, ecchymosis, and hematoma. The incidence of ecchymosis after injection ranges between 26-89%, and various factors such as injection site, needle size, injection duration, and techniques can influence these outcomes. Cold application is frequently used to reduce injection-related pain and bruising by inducing vasoconstriction, decreasing nerve conduction, and increasing pain tolerance.
In orthopedic surgery patients, limited injection sites due to dressings, casts, or splints may increase the risk of repeated bruising and pain. Although cold compresses have been studied in reducing injection-related complications, no research has evaluated the effect of cold spray prior to LMWH administration in this patient group. Therefore, standardized studies are needed to determine whether cold spray is an effective, practical alternative for reducing pain and ecchymosis following LMWH prophylaxis after orthopedic surgery.
Read the detailed description
Heparin is an anticoagulant used in the surgical prevention of thrombosis and can prevent and treat venous thrombosis by rapidly achieving its anticoagulant effects. Low molecular weight heparin (LMWH), a relatively new anticoagulant developed in the 1970s, has the advantages of high bioavailability, potent antithrombotic effect, a low risk of heparin-induced thrombocytopenia, and fewer bleeding side effects. Therefore, LMWH is increasingly used in clinical practice. Venous thromboembolism is a common complication during and after hospitalization in medical and surgical patients, including orthopedic patients. Without any prophylaxis, the incidence of fatal pulmonary embolism in hospitalized patients is 0.1-0.8% after elective general surgery, 2-3% after elective hip replacement, and 4-7% after hip fracture surgery. Therefore, patients receive heparin for several days or weeks from hospital admission until discharge.
Nurses, in their therapeutic role, administering medications is one of the most fundamental nursing functions requiring knowledge and skill.The basis of medication administration is to ensure patient safety, enhance the beneficial effects of the medication, prevent complications, and increase individual satisfaction and comfort.
The primary route of administration for low molecular weight heparin (LMWH) is subcutaneous injection into the abdominal area, midline of the triceps muscle, or lateral thigh. This method is preferred due to its easy accessibility and slow absorption of the medication. However, local side effects such as pain, ecchymosis (26.6%-88.9%), hematoma (40%-88%), and, in rare cases, tissue sclerosis can occur. Post-injection ecchymosis often occurs between 48 and 72 hours. Factors affecting the pain and bruising caused by subcutaneous injection of LMWH may include injection time; different injection sites; LMWH dose; needle size; slow delivery of heparin to tissues; use of the aspiration airlock technique; and cold application. Cold application has been frequently used to prevent injection-related pain and ecchymosis. In cold applications, when the skin temperature drops to 15 °C, vasoconstriction develops in superficial vessels, and vasodilation develops as the temperature drops even lower. Cold application reduces muscle spasm by slowing down the conduction properties of peripheral nerves and increases pain tolerance. Additionally, vasoconstriction resulting from cold application can reduce blood flow to the tissue, reducing bruising and hematoma formation.
After orthopedic surgery, patients are applied a dressing, bandage, cast, or splint, and post-traumatic bruising or ecchymosis can occur in many areas of the skin. Therefore, injection sites are limited, making rotation between these areas difficult. Using the same area can lead to the formation of new ecchymosis and increased pain sensitivity in the area. There are no studies in the literature on the effects of cold spray applied before SC LMWH application after orthopedic surgery. A more standardized and practical study is needed to evaluate the effects of cold spray on pain and ecchymosis, which can be achieved with cold compresses instead of cold compresses.
- Conditions
- Nursing Care, Cold Application, Pain, Ecchymosis
- Being tested
- Cold Spray Application
- Keywords
- nursing care, cold application, pain, ecchymosis
- Medical subject headings
- Pain, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Spray ApplicationOther
A cold spray is applied to the skin at the planned injection site immediately before LMWH administration to reduce pain and ecchymosis.
| Study group | Role | What they receive |
|---|---|---|
| Cold Spray Application | Experimental | In patients who receive standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery, cold spray is applied to the injection site before this injection. Receives: Other: Cold Spray Application |
| Standart (Routine) Care | No intervention | This injection is administered without cold application to patients receiving standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity at the injection site will be measured using the Visual Analog Scale (VAS). 10-cm VAS scale (0 = no pain, 10 = worst possible pain).
Measured: Immediately after each LMWH injection.
Ecchymosis Area
The size of ecchymosis at the injection site will be measured using the Opsite-Flexigrid transparent film. Area calculated in cm² by tracing the ecchymosis on the grid.
Measured: 48 and 72 hours after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Feb 2024
- Primary completion3 Feb 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Nursing CareStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted experimentally with a pre-test and post-test control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şükriye ŞAHİN, Kocaeli University
- Investigators
- YASEMİN ÖZHANLI, Assist.Prof, Study director, Kocaeli UniversityHATİCE MERVE ALPTEKİN, Research Assistant, Study chair, Kocaeli UniversityALİ OSMAN ALTUNTAŞ, Student, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195955
- Sponsor's protocol ID
- 2024/07.40.
- Status last verified
- Oct 2025
- First submitted
- 19 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ekanayake C, Gamage JCPH, Mendis P, Weerasinghe P. Revolution in orthopedic immobilization materials: A comprehensive review. Heliyon. 2023 Feb 16;9(3):e13640. doi: 10.1016/j.heliyon.2023.e13640. eCollection 2023 Mar.
PubMed 36915506Sendir M, Buyukyilmaz F, Celik Z, Taskopru I. Comparison of 3 methods to prevent pain and bruising after subcutaneous heparin administration. Clin Nurse Spec. 2015 May-Jun;29(3):174-80. doi: 10.1097/NUR.0000000000000129.
PubMed 25856035Erek Kazan, E. (2021). Hot and cold applications. In M. Kara Kaşıkçı & E. Akın (Eds.), Fundamentals of nursing: Concepts, principles, practices (1st ed., pp. 492-515). Istanbul Medical Bookstores.
Lafcı, D. (2021). Hot and cold applications. In N. Sabuncu, S. Erkal İlhan, & Z. Koç (Eds.), Fundamentals of nursing care: Concepts, principles, practices (pp. 801-823). Alter Publishing.
Çalışkan, N. (2021). Hot and cold applications. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills (2nd ed., pp. 567-586). Akademi Publishing.
Altaie, A. H., AbdulRazzaq, H. A., & Abd Al-hadi, A. (2013). Dose effect and risk factors on the severity of enoxaparin bruising side effect. International Journal of Clinical Pharmacy, 35(5), 950.
Palese A, Aidone E, Dante A, Pea F. Occurrence and extent of bruising according to duration of administration of subcutaneous low-molecular-weight heparin: a quasi-experimental case-crossover study. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):473-82. doi: 10.1097/JCN.0b013e3182578b87.
PubMed 22760174Bayram SB, Gulnar E, Caliskan N, Kosucu P, Bektas O, Bayram A, Aksoy F. The Effect of Two Types of Subcutaneous Heparin Injections on Pain, Ecchymosis, Hematoma and Drug Absorption: A Quasi-Experimental Study. J Eval Clin Pract. 2025 Feb;31(1):e14266. doi: 10.1111/jep.14266.
PubMed 39660578Amaniyan S, Varaei S, Vaismoradi M, Haghani H, Sieloff C. Effect of local cold and hot pack on the bruising of enoxaparin sodium injection site: a randomized controlled trial. Contemp Nurse. 2016 Feb;52(1):30-41. doi: 10.1080/10376178.2016.1190289. Epub 2016 Jun 5.
PubMed 27207493Karadag S, Aydinli A, Yilmaz C, Tutar N. Effect of cold application and compression on pain and bruising in subcutaneous heparin injection. J Vasc Nurs. 2023 Mar;41(1):22-26. doi: 10.1016/j.jvn.2023.01.002. Epub 2023 Jan 17.
PubMed 36898801Tosun, H. (2019). Medication management: Oral and local drug administration. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills. Akademi Publishing.
Taylor, C., Lynn, P., & Bartlett, J. (2018). Fundamentals of nursing: The art and science of person-centered care (pp. 59-380). Wolters Kluwer.
Duruk, N. (2023). Nursing functions and roles. In M. Kara Kaşıkçı & E. Akın (Eds.), Fundamentals of nursing: Concepts, principles, practices (pp. 11-17). Istanbul Medical Bookstores.
Flevas DA, Megaloikonomos PD, Dimopoulos L, Mitsiokapa E, Koulouvaris P, Mavrogenis AF. Thromboembolism prophylaxis in orthopaedics: an update. EFORT Open Rev. 2018 Apr 27;3(4):136-148. doi: 10.1302/2058-5241.3.170018. eCollection 2018 Apr.
PubMed 29780621Hallan SS, Kaur V, Jain V, Mishra N. Development and characterization of polymer lipid hybrid nanoparticles for oral delivery of LMWH. Artif Cells Nanomed Biotechnol. 2017 Dec;45(8):1631-1639. doi: 10.1080/21691401.2016.1276920. Epub 2017 Jan 10.
PubMed 28071140
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Spray Application in Reducing Pain and Ecchymosis in Patients Receiving Low Molecular Weight Heparin Prophylaxis After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07195955
- Acronym / sponsor ID
- 2024/07.40.
- Conditions
- Nursing Care, Cold Application, Pain, Ecchymosis
- Keywords
- nursing care, cold application, pain, ecchymosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 29 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.
Heparin is a widely used anticoagulant for thrombosis prevention, and low molecular weight heparin (LMWH) has become the preferred option due to its higher bioavailability, strong antithrombotic effect, and lower risk of complications. However, subcutaneous LMWH injections-commonly administered in the abdomen, arm, or thigh-often cause local side effects such as pain, ecchymosis, and hematoma. The incidence of ecchymosis after injection ranges between 26-89%, and various factors such as injection site, needle size, injection duration, and techniques can influence these outcomes. Cold application is frequently used to reduce injection-related pain and bruising by inducing vasoconstriction, decreasing nerve conduction, and increasing pain tolerance.
In orthopedic surgery patients, limited injection sites due to dressings, casts, or splints may increase the risk of repeated bruising and pain. Although cold compresses have been studied in reducing injection-related complications, no research has evaluated the effect of cold spray prior to LMWH administration in this patient group. Therefore, standardized studies are needed to determine whether cold spray is an effective, practical alternative for reducing pain and ecchymosis following LMWH prophylaxis after orthopedic surgery.
Detailed description
Heparin is an anticoagulant used in the surgical prevention of thrombosis and can prevent and treat venous thrombosis by rapidly achieving its anticoagulant effects. Low molecular weight heparin (LMWH), a relatively new anticoagulant developed in the 1970s, has the advantages of high bioavailability, potent antithrombotic effect, a low risk of heparin-induced thrombocytopenia, and fewer bleeding side effects. Therefore, LMWH is increasingly used in clinical practice. Venous thromboembolism is a common complication during and after hospitalization in medical and surgical patients, including orthopedic patients. Without any prophylaxis, the incidence of fatal pulmonary embolism in hospitalized patients is 0.1-0.8% after elective general surgery, 2-3% after elective hip replacement, and 4-7% after hip fracture surgery. Therefore, patients receive heparin for several days or weeks from hospital admission until discharge.
Nurses, in their therapeutic role, administering medications is one of the most fundamental nursing functions requiring knowledge and skill.The basis of medication administration is to ensure patient safety, enhance the beneficial effects of the medication, prevent complications, and increase individual satisfaction and comfort.
The primary route of administration for low molecular weight heparin (LMWH) is subcutaneous injection into the abdominal area, midline of the triceps muscle, or lateral thigh. This method is preferred due to its easy accessibility and slow absorption of the medication. However, local side effects such as pain, ecchymosis (26.6%-88.9%), hematoma (40%-88%), and, in rare cases, tissue sclerosis can occur. Post-injection ecchymosis often occurs between 48 and 72 hours. Factors affecting the pain and bruising caused by subcutaneous injection of LMWH may include injection time; different injection sites; LMWH dose; needle size; slow delivery of heparin to tissues; use of the aspiration airlock technique; and cold application. Cold application has been frequently used to prevent injection-related pain and ecchymosis. In cold applications, when the skin temperature drops to 15 °C, vasoconstriction develops in superficial vessels, and vasodilation develops as the temperature drops even lower. Cold application reduces muscle spasm by slowing down the conduction properties of peripheral nerves and increases pain tolerance. Additionally, vasoconstriction resulting from cold application can reduce blood flow to the tissue, reducing bruising and hematoma formation.
After orthopedic surgery, patients are applied a dressing, bandage, cast, or splint, and post-traumatic bruising or ecchymosis can occur in many areas of the skin. Therefore, injection sites are limited, making rotation between these areas difficult. Using the same area can lead to the formation of new ecchymosis and increased pain sensitivity in the area. There are no studies in the literature on the effects of cold spray applied before SC LMWH application after orthopedic surgery. A more standardized and practical study is needed to evaluate the effects of cold spray on pain and ecchymosis, which can be achieved with cold compresses instead of cold compresses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted experimentally with a pre-test and post-test control group.
| Arm | Type | Receives |
|---|---|---|
| Cold Spray Application | Experimental | Other: Cold Spray ApplicationIn patients who receive standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery, cold spray is applied to the injection site before this injection. |
| Standart (Routine) Care | No intervention | –This injection is administered without cold application to patients receiving standard and routine subcutaneous low molecular weight heparin (LMWH) prophylaxis after orthopedic surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Receiving 1 x 0.4 ml anticoagulant therapy
- Are on the first day of LMWH therapy
- Have no infection, scar tissue, lipodystrophy, or incision at the injection site
- Have not received any other parenteral therapy at the injection site
Key exclusion criteria (3 listed)
- Patients were excluded from the study if they were: • Pregnant, • Had any acute or chronic coagulation disorder or hematological disease,
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 |
|---|---|---|
| Cold Spray ApplicationA cold spray is applied to the skin at the planned injection site immediately before LMWH administration to reduce pain and ecchymosis. | Other | Cold Spray Application |
Primary outcome
Pain Intensity
Time frame: Immediately after each LMWH injection.
Pain intensity at the injection site will be measured using the Visual Analog Scale (VAS). 10-cm VAS scale (0 = no pain, 10 = worst possible pain).
Ecchymosis Area
Time frame: 48 and 72 hours after injection.
The size of ecchymosis at the injection site will be measured using the Opsite-Flexigrid transparent film. Area calculated in cm² by tracing the ecchymosis on the grid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 36915506Ekanayake C, Gamage JCPH, Mendis P, Weerasinghe P. Revolution in orthopedic immobilization materials: A comprehensive review. Heliyon. 2023 Feb 16;9(3):e13640. doi: 10.1016/j.heliyon.2023.e13640. eCollection 2023 Mar.
- Results publication: PubMed 25856035Sendir M, Buyukyilmaz F, Celik Z, Taskopru I. Comparison of 3 methods to prevent pain and bruising after subcutaneous heparin administration. Clin Nurse Spec. 2015 May-Jun;29(3):174-80. doi: 10.1097/NUR.0000000000000129.
- Results publicationErek Kazan, E. (2021). Hot and cold applications. In M. Kara Kaşıkçı & E. Akın (Eds.), Fundamentals of nursing: Concepts, principles, practices (1st ed., pp. 492-515). Istanbul Medical Bookstores.
- Results publicationLafcı, D. (2021). Hot and cold applications. In N. Sabuncu, S. Erkal İlhan, & Z. Koç (Eds.), Fundamentals of nursing care: Concepts, principles, practices (pp. 801-823). Alter Publishing.
- Results publicationÇalışkan, N. (2021). Hot and cold applications. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills (2nd ed., pp. 567-586). Akademi Publishing.
- Results publicationAltaie, A. H., AbdulRazzaq, H. A., & Abd Al-hadi, A. (2013). Dose effect and risk factors on the severity of enoxaparin bruising side effect. International Journal of Clinical Pharmacy, 35(5), 950.
- Results publication: PubMed 22760174Palese A, Aidone E, Dante A, Pea F. Occurrence and extent of bruising according to duration of administration of subcutaneous low-molecular-weight heparin: a quasi-experimental case-crossover study. J Cardiovasc Nurs. 2013 Sep-Oct;28(5):473-82. doi: 10.1097/JCN.0b013e3182578b87.
- Results publication: PubMed 39660578Bayram SB, Gulnar E, Caliskan N, Kosucu P, Bektas O, Bayram A, Aksoy F. The Effect of Two Types of Subcutaneous Heparin Injections on Pain, Ecchymosis, Hematoma and Drug Absorption: A Quasi-Experimental Study. J Eval Clin Pract. 2025 Feb;31(1):e14266. doi: 10.1111/jep.14266.
- Results publication: PubMed 27207493Amaniyan S, Varaei S, Vaismoradi M, Haghani H, Sieloff C. Effect of local cold and hot pack on the bruising of enoxaparin sodium injection site: a randomized controlled trial. Contemp Nurse. 2016 Feb;52(1):30-41. doi: 10.1080/10376178.2016.1190289. Epub 2016 Jun 5.
- Results publication: PubMed 36898801Karadag S, Aydinli A, Yilmaz C, Tutar N. Effect of cold application and compression on pain and bruising in subcutaneous heparin injection. J Vasc Nurs. 2023 Mar;41(1):22-26. doi: 10.1016/j.jvn.2023.01.002. Epub 2023 Jan 17.
- Results publicationTosun, H. (2019). Medication management: Oral and local drug administration. In T. Atabek Aşti & A. Karadağ (Eds.), Fundamentals of nursing: From knowledge to practice - Concepts, principles, skills. Akademi Publishing.
- Results publicationTaylor, C., Lynn, P., & Bartlett, J. (2018). Fundamentals of nursing: The art and science of person-centered care (pp. 59-380). Wolters Kluwer.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
YASEMİN ÖZHANLI, Assist.Prof study director
Kocaeli University
HATİCE MERVE ALPTEKİN, Research Assistant study chair
Kocaeli University
ALİ OSMAN ALTUNTAŞ, Student study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Spray Application in people with Nursing Care and Cold Application, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 7 Oct 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Immediately after each LMWH injection.). The study lists 2 primary outcomes in all. 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 NCT07195955, which also lists 16 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 7 Oct 2025.