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

Gulsum Coskun

Status: Active, not recruiting

Conditions: Injection Fear; Pain, Acute; Injection Site; Alloimmunisation in Pregnancy

Treatments: Other: Cold Spray; Other: Standard Injection Procedure; Other: Manuel Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06231719

Kartalsehir

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ability to understand, speak, read and understand Turkish
• Volunteering to participate in the study
• Being pregnant (gestational week 20 and above)
• Being between the ages of 18-45
• Has not had an IM injection in the last week
• There are no complications related to IM injections such as pain, abscess, infection, tissue necrosis, hematoma at the IM injection site.
• Not taking any analgesics before the procedure
• No chronic disease
• Those who do not have visual or cognitive impairments that prevent them from marking measurement tools

Exclusion criteria

• Not volunteering to participate in the study
• Having chronic pain disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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129 participants in 3 patient groups, including a placebo group

Anti-D Immunglobulin Injection with Cold Spray

Experimental group

Description:

Using cold spray before the Anti-D immunoglobulin injection

Treatment:

Other: Cold Spray

Anti-D Immunglobulin Injection with Manuel Pressure

Experimental group

Description:

Apply Manuel pressure before the Anti-D immunoglobulin injection

Treatment:

Other: Manuel Pressure

Standard Anti-D Immunoglobulin Injection

Placebo Comparator group

Description:

Standard procedure for Anti-D immunglobulin injection

Treatment:

Other: Standard Injection Procedure