An interventional study of Thermo mechanical device and local coolant spray in Pain and Ecchymosis, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 54 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5 minutes before and after application to the right upper abdominal region. local cold application
Other: ıce battery
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,
Other: Thermo mechanical device
Coolant spray will be applied to the upper left abdominal region for 15 sec.
Other: local coolant spray
SC injection will be applied to the left lower abdominal region without any cold application.
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,
Coolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm.
abdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama
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.
Time frame: 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.
Time frame: 5 day
Plan to share: Yes
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report
Ran from Jun 2020 to primary completion in Aug 2020, 2 months.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 2 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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