The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults

NCT06222216 | Recruiting

• 1 other identifier: Ali KAPLAN - Kayseri U
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Ecchymosis; A Randomized Controlled Trial; Subcutaneous Injections

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Intervention Group (Chilled Needle):

EXPERIMENTAL

Before subcutaneous injection, 26G sterile disposable needles will be kept in the cooling compartment of the refrigerator for at least 24 hours. Immediately before SC injection, the needle will be removed from the refrigerator, placed in the ice box and placed next to the patient's bed. The needle temperature will be kept at 0-2 degrees Celsius in the ice box and controlled using an LCD digital thermometer. If Enoxaparin Sodium is in the ready injector, the drug in the injector will be drawn into the injector suitable for 1 cc SC injection application without loss of dose. The needle of the prepared syringe will be replaced with a cooled needle. Afterwards, the injection will be made in the designated area (outer side of the upper arm) in accordance with the SC injection procedure steps. After the injection, the patient's pain assessment will be made and marked on the ILC, and ecchymosis assessment will be made after 24, 48 and 72 hours.

Other: Chilled Needle

Control Group:

ACTIVE COMPARATOR

SC injection will be administered to the control group in accordance with the clinical routine. No different procedure will be applied. Injection will be performed with a needle at room temperature without any instrument or procedure in accordance with the SC injection protocol. After the injection, the patient's pain assessment will be made and marked on the SCI, and ecchymosis assessment will be made after 24, 48 and 72 hours.

Other: Control Group

Interventions

Chilled Needle OTHER

Before subcutaneous injection, 26G sterile disposable needles will be kept in the refrigerated compartment of the refrigerator for at least 24 hours. Immediately before SC injection, the needle will be removed from the refrigerator, placed in the ice box and placed next to the patient's bed. The needle temperature will be kept at 0-2 degrees Celsius in the ice box and controlled using an LCD digital thermometer. If Enoxaparin Sodium is in the ready injector, the drug in the injector will be drawn into the injector suitable for 1 cc SC injection application without loss of dose. The needle of the prepared syringe will be replaced with a cooled needle. Afterwards, the injection will be made in the designated area (outer side of the upper arm) in accordance with the SC injection procedure steps. After the injection, the patient's pain assessment will be made and marked on the ILC, and ecchymosis assessment will be made after 24, 48 and 72 hours.

Intervention Group (Chilled Needle):

Control Group OTHER

SC injection will be administered to the control group in accordance with the clinical routine. No different action will be applied. The injection will be made in accordance with the SC injection protocol with a needle at room temperature, without applying any tools or procedures. After the injection, the patient's pain will be evaluated and marked on the VAS, and ecchymosis will be evaluated after 24, 48 and 72 hours.

Control Group:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to speak and understand Turkish,
• Those between the ages of 18-65,
• Oriented to place and time,
• Having no vision or hearing problems,
• Not using psychiatric medication due to any psychiatric disease,
• Not using central nervous system medication,
• Not using narcotic analgesics,
• Having a Visual Comparison Scale pain score of zero at the time of application,
• Those who have not had SC injection in the last month,
• Low molecular weight heparin therapy is ordered (Enoxaparin Sodium 1\*4000 IU),
• Having an average pressure pain threshold of 8-16 pounds (Lb) with the Baseline Algometer device,
• Has normal platelet, INR, and aPTT values,
• Individuals who volunteer to participate in the study and sign the written voluntary consent form will be included in the research.

You may not qualify if:

• Vital signs not within the reference range,
• Those with signs of phlebitis, scar tissue, dermatitis, incision and infection in the area where the intervention will be performed,
• Having had a mastectomy,
• Patients who declare that they are addicted to alcohol and drugs will not be included in the research.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Medical faculty hospital

Kayseri, Talas, 38280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Ecchymosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 24, 2024
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)