StrokeNCT06076434
Low-Molecular-Weight Heparin Injection in Stroke Patients
A study testing The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region in people with Stroke, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 15 May 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Hospitalized in the neurology clinic
- Who were administered at least once a day LMWH via subcutaneous injections in the arm
- Who agreed to participate in the study were included in this study
Who cannot join
- Patients who refused to participate in the study
- Patients with an INR value above 1.3 (hospital reference range was taken)
- Patients taking anticoagulant drugs were included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect on Bruising and Pain of Different Durations of Pressure Application Following Subcutaneous Heparin Injection to the Upper Arm
Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.
Read the detailed description
Anticoagulants are medicines that prevent blood from clotting as quickly or effectively as normal. Can be administered IV or subcutaneously. The main complications of heparin therapy are bleeding, thrombocytopenia and osteoporosis. Anticoagulants are classified as Vitamin K antagonist (VKA) (oral), Unfractionated heparin (UFH) (IV or subcutaneous), LMWHD (subcutaneous), Heparinoids (IV or subcutaneous), Fondaparinux (Subcutaneous), Oral factor Xa inhibitors, Parenteral direct thrombin inhibitors and Oral direct thrombin inhibitors. Subcutaneous administration of low-molecular-weight heparin (LMWH) may cause complications such as hematoma, bruising and pain at different injection sites. It is a goal of the nurse to reduce discomfort, anxiety, worry, refusal of treatment and lack of trust in the nurse due to bruising on the skin. Several studies have been conducted to investigate whether bruising and pain depend on injection sites; however, the results are conflicting and no clear and consistent conclusion has been reached. Subcutaneous heparin injection is a common nursing clinical intervention. Nurses often inject heparin subcutaneously and this action often causes some complications such as bruising, hematoma, pain and induration at the injection site. Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.
- Conditions
- Stroke
- Being tested
- The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region
- Keywords
- Anticoagulants, Injection, Nursing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm RegionOther
The injection site on the upper arm of each patient was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected into the tissue at a 90° angle with a 27 gauge needle. The heparin was injected in approximately 10 seconds without aspirating the syringe. After the injection, pressure was applied to the area with dry cotton for specified periods (10 second, 35 second and 60 second).
| Study group | Role | What they receive |
|---|---|---|
| Effect of 10 second Pressure Times on Bruising and Pain | Experimental | The patients were randomized according to age and gender and included in the groups.
Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. Receives: Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region |
| Effect of 35 second Pressure Times on Bruising and Pain | Experimental | The patients were randomized according to age and gender and included in the groups.
Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. Receives: Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region |
| Effect of 60 second Pressure Times on Bruising and Pain | Experimental | The patients were randomized according to age and gender and included in the groups.
Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. Receives: Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region
In this study, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after the injection, and the pain at the injection site after the pressure were measured with the Visual Analog Scale. Additionally, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after injection was examined for the development of bruising, ecchymosis and hematoma 48 hours later. Researchers marked an approximately 5 cm circle around the needle entry site using an acetate pen, and the level of bruising was measured and recorded 48 hours later using clear film.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Canan Kas, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076434
- Sponsor's protocol ID
- 2022-KEAK-102
- Status last verified
- Oct 2023
- First submitted
- 6 Jun 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Bruising and Pain of Different Durations of Pressure Application Following Subcutaneous Heparin Injection to the Upper Arm
- ClinicalTrials.gov ID
- NCT06076434
- Acronym / sponsor ID
- 2022-KEAK-102
- Conditions
- Stroke
- Keywords
- Anticoagulants, Injection, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 10 Oct 2023 (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.
Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.
Detailed description
Anticoagulants are medicines that prevent blood from clotting as quickly or effectively as normal. Can be administered IV or subcutaneously. The main complications of heparin therapy are bleeding, thrombocytopenia and osteoporosis. Anticoagulants are classified as Vitamin K antagonist (VKA) (oral), Unfractionated heparin (UFH) (IV or subcutaneous), LMWHD (subcutaneous), Heparinoids (IV or subcutaneous), Fondaparinux (Subcutaneous), Oral factor Xa inhibitors, Parenteral direct thrombin inhibitors and Oral direct thrombin inhibitors. Subcutaneous administration of low-molecular-weight heparin (LMWH) may cause complications such as hematoma, bruising and pain at different injection sites. It is a goal of the nurse to reduce discomfort, anxiety, worry, refusal of treatment and lack of trust in the nurse due to bruising on the skin. Several studies have been conducted to investigate whether bruising and pain depend on injection sites; however, the results are conflicting and no clear and consistent conclusion has been reached. Subcutaneous heparin injection is a common nursing clinical intervention. Nurses often inject heparin subcutaneously and this action often causes some complications such as bruising, hematoma, pain and induration at the injection site. Bruising as a result of heparin injection increases patients' anxiety, decreases their confidence in the effectiveness of nurses and causes them to refuse the injection. This undesirable effect can be reduced by using appropriate technique and taking a few simple precautions. In the systematic review conducted by İnangil and Şendir (2017) to systematically review the studies on the prevention of ecchymosis, hematoma and pain associated with subcutaneous heparin injection; it was determined that the number of studies investigating other techniques (pressure, site selection, etc.) was insufficient, with the highest number of studies on injection time and cold application. As a result of the research, it was recommended that local pressure should be applied to the area after injection, and the abdominal region should be preferred especially in patients who are sensitive to pain, since pain intensity is higher in the thigh and arm region. Due to the lack of literature, there is no consensus regarding the duration of compression to reduce bruising and pain after LMWH application. Based on these, this study was planned to compare the pressure applied to the injection point for 10, 35 and 60 seconds after injection in terms of pain, bruising and development of ecchymosis and hematoma at the injection sites in patients using subcutaneous heparin in the upper arm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Effect of 10 second Pressure Times on Bruising and Pain | Experimental | Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm RegionThe patients were randomized according to age and gender and included in the groups. Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. |
| Effect of 35 second Pressure Times on Bruising and Pain | Experimental | Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm RegionThe patients were randomized according to age and gender and included in the groups. Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. |
| Effect of 60 second Pressure Times on Bruising and Pain | Experimental | Other: The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm RegionThe patients were randomized according to age and gender and included in the groups. Patients were injected with heparin subcutaneously in the upper arm by the clinic nurse in accordance with the procedure of the clinic. The area was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected with a 27 gauge needle at a 90° angle to the tissue. The heparin was injected in approximately 10 seconds without aspirating the syringe. After injection, the area was pressurized with dry cotton wool for the specified time. After the injection, pressure was applied to the area with dry cotton for specified periods. Pain level was determined at the time of injection. Using an acetate pen, a circle of approximately 5 cm was marked around the needle insertion site and the bruising level was measured and recorded 48 hours later using a transparent film. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Hospitalized in the neurology clinic
- Who were administered at least once a day LMWH via subcutaneous injections in the arm
- Who agreed to participate in the study were included in this study
Key exclusion criteria (3 listed)
- Patients who refused to participate in the study
- Patients with an INR value above 1.3 (hospital reference range was taken)
- Patients taking anticoagulant drugs were included in the study
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 |
|---|---|---|
| The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm RegionThe injection site on the upper arm of each patient was cleaned with alcohol and after the alcohol was dried, 0.6 ml of subcutaneous heparin was injected into the tissue at a 90° angle with a 27 gauge needle. The heparin was injected in approximately 10 seconds without aspirating the syringe. After the injection, pressure was applied to the area with dry cotton for specified periods (10 second, 35 second and 60 second). | Other | Effect of 10 second Pressure Times on Bruising and Pain, Effect of 35 second Pressure Times on Bruising and Pain, Effect of 60 second Pressure Times on Bruising and Pain |
Primary outcome
The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region
Time frame: 48 hours
In this study, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after the injection, and the pain at the injection site after the pressure were measured with the Visual Analog Scale. Additionally, in patients using LMWH on the upper arm, the pressure applied to the injection point for 10, 35 and 60 seconds after injection was examined for the development of bruising, ecchymosis and hematoma 48 hours later. Researchers marked an approximately 5 cm circle around the needle entry site using an acetate pen, and the level of bruising was measured and recorded 48 hours later using clear film.
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 10 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region in people with Stroke, run by Kastamonu 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 4 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 10 Oct 2023. 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?
The Effect of Different Pressure Periods on Bruising and Pain After Subcutaneous Heparin Injection Applied to the Upper Arm Region (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.