NCT06231719

Efficacy of Manuel Pressure and Local Cold Spray in Reducing Injection Pain in Pregnant Women

Evaluation of the Efficacy of Manual Pressure and Local Cold Spray Application in Reducing Pain Caused by Human Anti-D Immunoglobulin Injection in Pregnant Women: A Randomized Controlled Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Gulsum Coskun · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human Anti-D immunoglobulin injection administered to pregnant women.

Detailed description

Injections are a commonly used treatment method that can induce fear, tension and anxiety in individuals despite their frequent use. The use of long needles, especially for intramuscular injections, to reach the target area through an injection can disrupt tissue integrity and cause discomfort. Therefore, injection pain is a widespread problem. Depending on the severity of perceived pain, it can affect an individual's hemodynamic parameters. Pain-related factors such as high heart rate, blood pressure, low oxygen saturation, and hyperventilation can develop. Primary caregivers, such as nurses, attempt to minimize pain by using pharmacological methods (local anesthesia, adjuvant analgesia, non-steroidal anti-inflammatory drugs (NSAID), opioids, paracetamol) and non-pharmacological interventions (manual pressure, cold application, Helfer skin tap, Shotblocker, massage, internal rotation, Buzzy). Human Anti-D immunoglobulin injection, like all other injections, causes pain, negatively affecting the quality of life and treatment experiences of individuals. In our study, we aim to evaluate the effectiveness of pre-injection manual pressure and local cold spray application, create data in the clinical field and reduce injection pain in pregnant women to have a positive impact on injection satisfaction and hemodynamic parameters.

Conditions

• Pain, Acute
• Alloimmunisation in Pregnancy
• Injection Site
• Injection Fear

Interventions

Type	Name	Description
OTHER	Cold Spray	Using cold spray for injection site before the Anti-D immunglobulin injection. 2 sprays of cold spray are applied from a distance of 25 cm.
OTHER	Manuel Pressure	Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.
OTHER	Standard Injection Procedure	Using any special method for injection

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-07-01
• Completion: 2024-07-30
• First posted: 2024-01-30
• Last updated: 2024-06-05

Locations

1 site across 1 country: Turkey (Türkiye)