Pain Clinical Trial
Official title:
The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults: A Prospective, Randomized Controlled Study
Verified date | May 2024 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subcutaneous (SC) injection applications are the process of administering the drug to the loose connective tissue under the skin and is one of the most frequently applied parenteral drug administration methods among nursing practices. SC injections, which are frequently performed by nurses, often result in complications such as hematoma, ecchymosis and pain at the injection site. Although the field of healthcare is developing day by day, injection applications can still be painful and uncomfortable. These procedures increase the individual's stress levels before the procedure, causing them to experience fear and anxiety and reducing patient satisfaction. This may cause the application to fail or be repeated. Many nonpharmacological methods are applied to prevent or reduce these local side effects in subcutaneous injection applications. Cold application is accepted as an effective and easy-to-use method for SC injection. Cold application may also constrict peripheral blood vessels, reducing blood flow to the tissue and thus preventing ecchymosis. When the national and international literature is examined, there are studies using cold application to reduce pain and ecchymosis due to SC injection in adults. This study aimed to evaluate the effectiveness of cold injection, which is considered an alternative to cold therapy, in reducing pain and ecchymosis due to SC injection application. No study has been found in the literature evaluating the effectiveness of cold injection in preventing pain and ecchymosis due to SC injection application. Therefore, it is thought that this study will make a significant contribution to the literature and create a simple, comfortable and cost-free innovation. Preparation and use of cold injection is simple, easy and comfortable. It is anticipated that patients will be able to easily follow the procedure steps during the procedure. Therefore, this study aimed to examine the effect of the cooled needle on the development of pain and ecchymosis in SC injection application in adults.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Able to speak and understand Turkish, 2. Those between the ages of 18-65, 3. Oriented to place and time, 4. Having no vision or hearing problems, 5. Not using psychiatric medication due to any psychiatric disease, 6. Not using central nervous system medication, 7. Not using narcotic analgesics, 8. Having a Visual Comparison Scale pain score of zero at the time of application, 9. Those who have not had SC injection in the last month, 10. Low molecular weight heparin therapy is ordered (Enoxaparin Sodium 1*4000 IU), 11. Having an average pressure pain threshold of 8-16 pounds (Lb) with the Baseline Algometer device, 12. Has normal platelet, INR, and aPTT values, 13. Individuals who volunteer to participate in the study and sign the written voluntary consent form will be included in the research. Exclusion Criteria: 1. Vital signs not within the reference range, 2. Those with signs of phlebitis, scar tissue, dermatitis, incision and infection in the area where the intervention will be performed, 3. Having had a mastectomy, 4. Patients who declare that they are addicted to alcohol and drugs will not be included in the research. |
Country | Name | City | State |
---|---|---|---|
Turkey | Erciyes University Medical faculty hospital | Kayseri | Talas |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Individual Introduction Form | The form prepared by the researcher by examining the relevant literature; individuals' age, gender, marital status, etc. It consists of 7 questions that include socio-demographic characteristics such as. The individual identification form will be filled out by the researcher by meeting individuals face to face. | 6 months | |
Primary | Visual Comparison Scale | The Visual Comparison Scale is a scale used to measure pain intensity. It is used to convert the pain value that cannot be measured numerically into numerical form. Two extreme definitions of the pain parameter are written at both ends of a 100 mm line, and the patient is asked to indicate where his/her condition is appropriate on this line by drawing a line, placing a dot, or pointing. It is a 100 mm (10 cm) ruler that can be used horizontally and vertically, with "painlessness" written on one end and "most severe pain possible" on the other end. "0 mm" means no pain, and "100 mm" means the most severe pain. The individual indicates the intensity of pain he feels on this ruler. Pain intensity score measurements will be evaluated in mm. | 6 months | |
Primary | Octoberosis Tracking Chart | It is a form developed by researchers to track the development of ecchymosis in patients after subcutaneous injection, in which the date and time of SC injection and the ecchymosis at 24, 48, and 72 hours after injection are recorded.
In the project, an acetate pen will be used to measure ecchymosis in the injection area. In the literature, color changes smaller than 2 mm2 are not considered ecchymosis. Based on this information, in this study, color change smaller than 2 mm will be categorized as "no ecchymosis" and color change 2 mm and above will be categorized as "ecchymosis present". |
6 months |
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