PainNCT04235244
The Effect of Three Different Local Cold Applications on Pain and Ecchymosis in Subcutaneous Heparin Injections
A study testing Thermo mechanical device, local coolant spray and ıce battery in people with Pain and Ecchymosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of three different cold application methods on ecchymosis and pain in the injection site in patients who received DMAH injection from the SC route. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Ecchymosis
- What is being tested?
- Thermo mechanical device, local coolant spray and ıce battery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 25 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is 18 years or older,
- Planning LMWH treatment by SC twice a day,
- Has the physical and mental competence to correctly evaluate the Visual Analog Scale (VAS),
- Platelet value is 100 000 / mm³ and ↑
- Prothrombin time (INR) is between 0.87-1.20,
- aPTT value between 22-36 (Platelet, PT and aPTT tests were evaluated considering the reference values of the kits used in the hospital)
Show all 11Show fewer
- No coagulation disorder,
- Not using oral anticoagulants,
- No scar tissue, incision, lipodystrophy or signs of infection on the skin of the abdomen to be injected,
- No history of cold allergy,
- Agree to participate in the research
Who cannot join
- Patients who do not agree to participate in the study or who give up during the study and are discharged before the follow-up of SC injection activities will not be included in the sample.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Unıversıty- Cerrahpaşa
Şişli, Istanbul, 34510
About this study
The aim of this study was to investigate the effects of three different cold application methods on ecchymosis and pain in the injection site in patients who received DMAH injection from the SC route.
In the Turkish Republic of Northern Cyprus, the research universe will be composed of the patients who underwent DMAH from the SC path in Internal Medicine Service at a State Hospital under the Ministry of Health. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample size (d=0.785) was found by reference from the article "effect of ice application on ecchymosis formation in patients undergoing subcutaneous anticoagulant therapy" by Küçükgüçlü and Okumu (2010) and the sample size required for 1-β=0.95 (power) in α=0.05 was n = 38.
Read more
Patient Data Sheet, SC Road injection tracking chart, Visual Analog scale, Opsite - Flexigrid measurement tool, Mekano-analgesia (Buzzy) device, local coolant spray and acetate Pen will be used for data collection.
Statistical Package for Social Sciences (SPSS) 25.0 software will be used for statistical analysis of research data. If the data set matches the normal distribution, parametric hypothesis tests will be used, and if the data set does not match the normal distribution, nonparametric hypothesis tests will be used.
Read the detailed description
Thromboembolism is a frequently seen complication in patients who undergo long-term movement restriction and undergo surgical intervention, causing serious consequences such as pulmonary embolism . For this reason, heparin is frequently used for protective or therapeutic purposes in clinical situations where there is a risk of venous thromboembolism or thromboembolytic events . In the 1980s, low molecular weight heparin (LMWH) preparations, often administered subcutaneously (SC), were developed in order to increase the desired effect and reduce the side effects of heparin applications . It is stated in the literature that SC injection applications can be safely injected into the outer-lateral side of the upper arm, anterior aspect of the thigh, under the scapula and abdominal region . However, in the literature, it is emphasized that ecchymosis and hematoma formation is more common in SC LMWH applications, especially in the arm and thigh areas after SC injection. Therefore, in LMWH applications, it is stated that abdominal region is the most reliable injection site because it has thicker SC tissue compared to other parts of the body . In summary studies, it is recommended as the preferred site for LMWH applications due to the excess of SC fat tissue in the abdominal region, its width to allow rotation of the injection site and the lack of muscle activity .
Systemic and local complications may occur due to heparin injection by SC route. The most important local complications are; ecchymosis at the injection site, hematoma formation and local pain formation at the injection site . In this study, the frequency of ecchymosis; Kuz and Uçar (2001) 11.4%, Dursun and Balcı Akpınar (2014) 28.7%, Küçükgüçlü and Okumuş (2010) 31%, Varghese et al. (2006) 36%, Palese (2013) 38%, Yildirim and Atalay (2005) 57%, Zaybak and Khorshid (2008) reported as 64%. These treatment-related complications complicate the use of the damaged area in subsequent injections, adversely affect drug absorption, and cause physical trauma (ecchymosis, hematoma and pain) and changes in body image.
Pain is a subjective experience that can occur in very different qualities and severity. Pain experienced due to injection is generally defined as a condition that occurs as a result of mechanical trauma in the tissue and stimulates the nerve fiber ends with the entry of the needle into the tissue. Due to the presence of pain receptors in SC tissue, patients often experience discomfort and pain during and after LMWH applications. Pain during injection significantly affects the patient's non-compliance to treatment and pain after injection significantly affects the comfort and life activities of the patient by restricting the use of the extremity . One of the methods used to prevent these negative complications is cold applications.
Local cold administration reduces blood flow through vasoconstriction of the arterioles, controls bleeding and reduces ecchymosis and hematoma development . In addition, local cold application provides vasoconstriction in the tissue to which it is applied, slows blood flow and increases the viscosity of the blood, limits edema and inflammatory process, controls bleeding by reducing capillary permability, and reduces pain perception . With this localized sensory effect, attention is directed towards cold from pain, and thus pain is alleviated by the anesthetic effect of cold . In the studies carried out on the subject; It has been reported that 5 minutes of local humid cold application after SC injection results in a reduction in the severity and pain rate of ecchymosis . Küçükgüçlü and Okumuş (2010); SC indicated that two minutes of ice application to the heparin administration site before and after administration was an effective method of reducing ecchymosis and hematoma. Avşar and Kaşıkçı (2013); They found that two minutes of cold application to the SC injection site reduced ecchymosis and pain. Şendir et al. (2015) SC injection time of 30 seconds and 5 minutes before and after the injection of local ice application, effective in reducing the intensity of pain and ecchymosis was reported to be effective. Similarly, Korkmazcan (2016) emphasizes that application of local ice to the skin is effective for reducing ecchymosis, hematoma and pain in SC LMWH injections. In addition, it is reported that pre-injection coolant spray and thermo-mechanical analgesia method reduce pain intensity in LMWH applications via SC .
SC injection applications are an important part of drug applications and are frequently performed by nurses in clinical practice. Complications resulting from these applications cause physical and mental trauma in patients, they are reluctant to make the next injection, and for nurses, ecchymosis, hematoma and pain occurring at the injection site play a restrictive role in the selection of the site. This is an important problem for patients receiving heparin treatment for a long time; It is seen that different cold application methods such as ice application, cooling spray and thermo-mechanical analgesia techniques are used in heparin injections by SC route. However, there is no study on which these methods are used together and the effects of these methods are compared. This work; The aim of this study was to investigate the effect of three different cold application methods on ecchymosis and pain formation at the injection site in patients undergoing LMWH injection via SC.
- Conditions
- Pain, Ecchymosis
- Being tested
- Thermo mechanical device, local coolant spray, ıce battery
- Keywords
- subcutaneous ınjectıon, cold application, pain, ecchymosis, heparin injection
- Medical subject headings
- Pain, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermo mechanical deviceOther
The thermomechanical-analgesia device will be placed and operated 30 seconds before the injection into the abdominal area,and injection will be applied by sliding the device to the side of the selected region during the injection,
local coolant sprayOther
Coolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm.
ıce batteryOther
abdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama
| Study group | Role | What they receive |
|---|---|---|
| left lower abdominal region | Experimental | 5 minutes before and after application to the right upper abdominal region. local cold application Receives: Other: ıce battery |
| right upper abdominal region | Experimental | Thermomechanical-analgesia device will be operated 30 seconds before the injection in the right lower abdominal region and the device will be injected by sliding the device to the side of the selected region during the injection, Receives: Other: Thermo mechanical device |
| left upper abdominal region | Experimental | Coolant spray will be applied to the upper left abdominal region for 15 sec. Receives: Other: local coolant spray |
| right lower abdominal region | No intervention | SC injection will be applied to the left lower abdominal region without any cold application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects Of Ice Application On Pain In Patients Undergoing Subcutaneous Anticoagulant Therapy
According to the randomization result;
- Buzzy, a thermomechanical-analgesia device, was placed 30 seconds before the injection in the right upper abdominal region, and the SC injection was applied by sliding the device to the side of the selected region during the injection (Thermomechanical-Analgesia Group),
- SC-LMWH injection was applied to the right lower abdominal region without any cold application (Control Group),
- Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds (Local coolant spray group) and
- Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes (Cool-pack group).
It was used to evaluate the pain intensity of the patients during and after SC injection. The patient was asked to indicate the pain intensity on a scale immediately after the SC injection and on the 24th, 48th, and 72nd hours after the injection.
Measured: 5 day
Effects Of Ice Application On Ecchymosis In Patients Undergoing Subcutaneous Anticoagulant Therapy
It is a transparent measurement tool designed to measure the size of the ecchymosis formed in the SC injection site, in millimeters. Ecchymosis size was measured with the "Optite-Flexigrid Measurement Tool" in the ecchymoses formed in the 24th, 48th, and 72nd hours after SC-LMWH injection.
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2020
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- It will be determined by simple randomization method which SC injection will be applied to these four regions. According to the results of randomization; * Buzzy, a thermomechanical-analgesia device, was placed 30 seconds before the injection in the right upper abdominal region, and the SC injection was applied by sliding the device to the side of the selected region during the injection * SC-LMWH injection was applied to the right lower abdominal region without any cold application * Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds and * Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes. The application of 2x0.6cc standard ready-to-use injectable Enoxiparin, which was requested by the physician according to the SC injection application steps, was applied together with the cold application method determined by randomization.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda CEVHEROĞLU, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235244
- Sponsor's protocol ID
- IU-C NURSİNG
- Status last verified
- May 2022
- First submitted
- 16 Jan 2020
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sendir 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 25856035Akbari Sari A, Janani L, Mohammady M, Nedjat S. Slow versus fast subcutaneous heparin injections for prevention of bruising and site-pain intensity. Cochrane Database Syst Rev. 2014 Jul 18;(7):CD008077. doi: 10.1002/14651858.CD008077.pub3.
PubMed 25036897Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.
PubMed 26162573Palese 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 22760174Mohammady M, Janani L, Akbari Sari A. Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity. Cochrane Database Syst Rev. 2017 Nov 1;11(11):CD008077. doi: 10.1002/14651858.CD008077.pub5.
PubMed 29090459Cengiz Z, Ozkan M. Comparison of abdominal and arm areas in patients receiving subcutaneous heparin in terms of development of pain, hematoma, and ecchymosis. J Vasc Nurs. 2018 Dec;36(4):208-215. doi: 10.1016/j.jvn.2018.06.003. Epub 2018 Jul 10.
PubMed 30458944Zaybak A, Khorshid L. A study on the effect of the duration of subcutaneous heparin injection on bruising and pain. J Clin Nurs. 2008 Feb;17(3):378-85. doi: 10.1111/j.1365-2702.2006.01933.x. Epub 2007 Oct 11.
PubMed 17931375Kuzu N, Ucar H. The effect of cold on the occurrence of bruising, haematoma and pain at the injection site in subcutaneous low molecular weight heparin. Int J Nurs Stud. 2001 Feb;38(1):51-9. doi: 10.1016/s0020-7489(00)00061-4.
PubMed 11137723Balci Akpinar R, Celebioglu A. Effect of injection duration on bruising associated with subcutaneous heparin: a quasi-experimental within-subject design. Int J Nurs Stud. 2008 Jun;45(6):812-7. doi: 10.1016/j.ijnurstu.2007.02.005. Epub 2007 Mar 30.
PubMed 17399715
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Local Cold Applications on Pain and Ecchymosis in Subcutaneous Heparin Injections
- ClinicalTrials.gov ID
- NCT04235244
- Acronym / sponsor ID
- IU-C NURSİNG
- Conditions
- Pain, Ecchymosis
- Keywords
- subcutaneous ınjectıon, cold application, pain, ecchymosis, heparin injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 21 Jan 2020 (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.
The aim of this study was to investigate the effects of three different cold application methods on ecchymosis and pain in the injection site in patients who received DMAH injection from the SC route.
In the Turkish Republic of Northern Cyprus, the research universe will be composed of the patients who underwent DMAH from the SC path in Internal Medicine Service at a State Hospital under the Ministry of Health. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample will consist of patients who meet the research criteria, who are informed about the purpose of the research, and who are willing to participate after obtaining the permission of the Ethics Committee and institution. The sample size (d=0.785) was found by reference from the article "effect of ice application on ecchymosis formation in patients undergoing subcutaneous anticoagulant therapy" by Küçükgüçlü and Okumu (2010) and the sample size required for 1-β=0.95 (power) in α=0.05 was n = 38.
Patient Data Sheet, SC Road injection tracking chart, Visual Analog scale, Opsite - Flexigrid measurement tool, Mekano-analgesia (Buzzy) device, local coolant spray and acetate Pen will be used for data collection.
Statistical Package for Social Sciences (SPSS) 25.0 software will be used for statistical analysis of research data. If the data set matches the normal distribution, parametric hypothesis tests will be used, and if the data set does not match the normal distribution, nonparametric hypothesis tests will be used.
Detailed description
Thromboembolism is a frequently seen complication in patients who undergo long-term movement restriction and undergo surgical intervention, causing serious consequences such as pulmonary embolism . For this reason, heparin is frequently used for protective or therapeutic purposes in clinical situations where there is a risk of venous thromboembolism or thromboembolytic events . In the 1980s, low molecular weight heparin (LMWH) preparations, often administered subcutaneously (SC), were developed in order to increase the desired effect and reduce the side effects of heparin applications . It is stated in the literature that SC injection applications can be safely injected into the outer-lateral side of the upper arm, anterior aspect of the thigh, under the scapula and abdominal region . However, in the literature, it is emphasized that ecchymosis and hematoma formation is more common in SC LMWH applications, especially in the arm and thigh areas after SC injection. Therefore, in LMWH applications, it is stated that abdominal region is the most reliable injection site because it has thicker SC tissue compared to other parts of the body . In summary studies, it is recommended as the preferred site for LMWH applications due to the excess of SC fat tissue in the abdominal region, its width to allow rotation of the injection site and the lack of muscle activity .
Systemic and local complications may occur due to heparin injection by SC route. The most important local complications are; ecchymosis at the injection site, hematoma formation and local pain formation at the injection site . In this study, the frequency of ecchymosis; Kuz and Uçar (2001) 11.4%, Dursun and Balcı Akpınar (2014) 28.7%, Küçükgüçlü and Okumuş (2010) 31%, Varghese et al. (2006) 36%, Palese (2013) 38%, Yildirim and Atalay (2005) 57%, Zaybak and Khorshid (2008) reported as 64%. These treatment-related complications complicate the use of the damaged area in subsequent injections, adversely affect drug absorption, and cause physical trauma (ecchymosis, hematoma and pain) and changes in body image.
Pain is a subjective experience that can occur in very different qualities and severity. Pain experienced due to injection is generally defined as a condition that occurs as a result of mechanical trauma in the tissue and stimulates the nerve fiber ends with the entry of the needle into the tissue. Due to the presence of pain receptors in SC tissue, patients often experience discomfort and pain during and after LMWH applications. Pain during injection significantly affects the patient's non-compliance to treatment and pain after injection significantly affects the comfort and life activities of the patient by restricting the use of the extremity . One of the methods used to prevent these negative complications is cold applications.
Local cold administration reduces blood flow through vasoconstriction of the arterioles, controls bleeding and reduces ecchymosis and hematoma development . In addition, local cold application provides vasoconstriction in the tissue to which it is applied, slows blood flow and increases the viscosity of the blood, limits edema and inflammatory process, controls bleeding by reducing capillary permability, and reduces pain perception . With this localized sensory effect, attention is directed towards cold from pain, and thus pain is alleviated by the anesthetic effect of cold . In the studies carried out on the subject; It has been reported that 5 minutes of local humid cold application after SC injection results in a reduction in the severity and pain rate of ecchymosis . Küçükgüçlü and Okumuş (2010); SC indicated that two minutes of ice application to the heparin administration site before and after administration was an effective method of reducing ecchymosis and hematoma. Avşar and Kaşıkçı (2013); They found that two minutes of cold application to the SC injection site reduced ecchymosis and pain. Şendir et al. (2015) SC injection time of 30 seconds and 5 minutes before and after the injection of local ice application, effective in reducing the intensity of pain and ecchymosis was reported to be effective. Similarly, Korkmazcan (2016) emphasizes that application of local ice to the skin is effective for reducing ecchymosis, hematoma and pain in SC LMWH injections. In addition, it is reported that pre-injection coolant spray and thermo-mechanical analgesia method reduce pain intensity in LMWH applications via SC .
SC injection applications are an important part of drug applications and are frequently performed by nurses in clinical practice. Complications resulting from these applications cause physical and mental trauma in patients, they are reluctant to make the next injection, and for nurses, ecchymosis, hematoma and pain occurring at the injection site play a restrictive role in the selection of the site. This is an important problem for patients receiving heparin treatment for a long time; It is seen that different cold application methods such as ice application, cooling spray and thermo-mechanical analgesia techniques are used in heparin injections by SC route. However, there is no study on which these methods are used together and the effects of these methods are compared. This work; The aim of this study was to investigate the effect of three different cold application methods on ecchymosis and pain formation at the injection site in patients undergoing LMWH injection via SC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- It will be determined by simple randomization method which SC injection will be applied to these four regions. According to the results of randomization; * Buzzy, a thermomechanical-analgesia device, was placed 30 seconds before the injection in the right upper abdominal region, and the SC injection was applied by sliding the device to the side of the selected region during the injection * SC-LMWH injection was applied to the right lower abdominal region without any cold application * Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds and * Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes. The application of 2x0.6cc standard ready-to-use injectable Enoxiparin, which was requested by the physician according to the SC injection application steps, was applied together with the cold application method determined by randomization.
| Arm | Type | Receives |
|---|---|---|
| left lower abdominal region | Experimental | Other: ıce battery5 minutes before and after application to the right upper abdominal region. local cold application |
| right upper abdominal region | Experimental | Other: Thermo mechanical deviceThermomechanical-analgesia device will be operated 30 seconds before the injection in the right lower abdominal region and the device will be injected by sliding the device to the side of the selected region during the injection, |
| left upper abdominal region | Experimental | Other: local coolant sprayCoolant spray will be applied to the upper left abdominal region for 15 sec. |
| right lower abdominal region | No intervention | –SC injection will be applied to the left lower abdominal region without any cold application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The patient is 18 years or older,
- Planning LMWH treatment by SC twice a day,
- Has the physical and mental competence to correctly evaluate the Visual Analog Scale (VAS),
- Platelet value is 100 000 / mm³ and ↑
- Prothrombin time (INR) is between 0.87-1.20,
Key exclusion criteria (1 listed)
- Patients who do not agree to participate in the study or who give up during the study and are discharged before the follow-up of SC injection activities will not be included in the sample.
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 |
|---|---|---|
| Thermo mechanical deviceThe thermomechanical-analgesia device will be placed and operated 30 seconds before the injection into the abdominal area,and injection will be applied by sliding the device to the side of the selected region during the injection, | Other | right upper abdominal region |
| local coolant sprayCoolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm. | Other | left upper abdominal region |
| ıce batteryabdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama | Other | left lower abdominal region |
Primary outcome
Effects Of Ice Application On Pain In Patients Undergoing Subcutaneous Anticoagulant Therapy
Time frame: 5 day
According to the randomization result; * Buzzy, a thermomechanical-analgesia device, was placed 30 seconds before the injection in the right upper abdominal region, and the SC injection was applied by sliding the device to the side of the selected region during the injection (Thermomechanical-Analgesia Group), * SC-LMWH injection was applied to the right lower abdominal region without any cold application (Control Group), * Local coolant spray was applied to the left upper abdominal region from a distance of 15 cm for 5 seconds (Local coolant spray group) and * Before and after the application to the left lower abdominal region, the cold application was performed with a cool-pack for 5 minutes (Cool-pack group). It was used to evaluate the pain intensity of the patients during and after SC injection. The patient was asked to indicate the pain intensity on a scale immediately after the SC injection and on the 24th, 48th, and 72nd hours after the injection.
Effects Of Ice Application On Ecchymosis In Patients Undergoing Subcutaneous Anticoagulant Therapy
Time frame: 5 day
It is a transparent measurement tool designed to measure the size of the ecchymosis formed in the SC injection site, in millimeters. Ecchymosis size was measured with the "Optite-Flexigrid Measurement Tool" in the ecchymoses formed in the 24th, 48th, and 72nd hours after SC-LMWH injection.
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 16 May 2022.
- 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 publication: PubMed 25036897Akbari Sari A, Janani L, Mohammady M, Nedjat S. Slow versus fast subcutaneous heparin injections for prevention of bruising and site-pain intensity. Cochrane Database Syst Rev. 2014 Jul 18;(7):CD008077. doi: 10.1002/14651858.CD008077.pub3.
- Results publication: PubMed 26162573Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.
- 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 29090459Mohammady M, Janani L, Akbari Sari A. Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity. Cochrane Database Syst Rev. 2017 Nov 1;11(11):CD008077. doi: 10.1002/14651858.CD008077.pub5.
- Results publication: PubMed 30458944Cengiz Z, Ozkan M. Comparison of abdominal and arm areas in patients receiving subcutaneous heparin in terms of development of pain, hematoma, and ecchymosis. J Vasc Nurs. 2018 Dec;36(4):208-215. doi: 10.1016/j.jvn.2018.06.003. Epub 2018 Jul 10.
- Results publication: PubMed 17931375Zaybak A, Khorshid L. A study on the effect of the duration of subcutaneous heparin injection on bruising and pain. J Clin Nurs. 2008 Feb;17(3):378-85. doi: 10.1111/j.1365-2702.2006.01933.x. Epub 2007 Oct 11.
- Results publication: PubMed 11137723Kuzu N, Ucar H. The effect of cold on the occurrence of bruising, haematoma and pain at the injection site in subcutaneous low molecular weight heparin. Int J Nurs Stud. 2001 Feb;38(1):51-9. doi: 10.1016/s0020-7489(00)00061-4.
- Results publication: PubMed 17399715Balci Akpinar R, Celebioglu A. Effect of injection duration on bruising associated with subcutaneous heparin: a quasi-experimental within-subject design. Int J Nurs Stud. 2008 Jun;45(6):812-7. doi: 10.1016/j.ijnurstu.2007.02.005. Epub 2007 Mar 30.
- Individual participant dataSharing planned: Yes
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Postoperative Pain
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Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Thermo mechanical device, local coolant spray and ıce battery in people with Pain and Ecchymosis, run by Istanbul University - Cerrahpasa 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 11 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: finished, as of the sponsor's last update on 16 May 2022. 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?
Effects Of Ice Application On Pain In Patients Undergoing Subcutaneous Anticoagulant Therapy (time frame: 5 day). 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 NCT04235244, which also lists 9 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 16 May 2022.