Using chilled needles to reduce pain and bruising from injections

The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults: A Prospective, Randomized Controlled Study

This study tests if using chilled needles for injections can help reduce pain and bruising for people getting shots.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: TC Erciyes University (other)
• Locations: 1 site (Kayseri, Talas)
• Trial ID: NCT06222216 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of using chilled needles during subcutaneous injections to minimize pain and ecchymosis. It involves a randomized controlled trial where participants receive either a chilled needle or a standard needle for their injections. The study aims to assess the impact of cold application on reducing local side effects associated with injections, which can lead to increased patient satisfaction and reduced anxiety. Participants will be monitored for pain levels and bruising after the injection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 who are undergoing low molecular weight heparin therapy and meet specific health criteria.

Not a fit: Patients with certain medical conditions, such as those with vital signs outside the reference range or signs of infection at the injection site, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce pain and bruising for patients receiving subcutaneous injections.

How similar studies have performed: Previous studies have shown that cold application can effectively reduce pain and ecchymosis from injections, suggesting this approach may be beneficial.

Eligibility criteria

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.

Where this trial is running

Kayseri, Talas

• Erciyes University Medical faculty hospital — Kayseri, Talas, Turkey (Türkiye) (RECRUITING)

Conditions: Pain, Ecchymosis, A Randomized Controlled Trial, Subcutaneous Injections