Clinical trial NCT06231719: Efficacy of Manuel Pressure and Local Cold Spray in Reducing Injection Pain in Pregnant Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Acute
Alloimmunisation in Pregnancy
Injection Site
Injection Fear
Keywords: Human Anti-D Immunglobulin
Red Blood Cell
Alloimmunization
Injection Pain
Local Cold Therapy
Manuel Pressure
Pregnancy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two intervention ,one control group
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: Approximately 3 minute after injection
measure: Injection Satisfaction
timeFrame: Approximately 4 minute after injection
measure: Pain Fear
timeFrame: Before injection
measure: Introductory Information Form
timeFrame: After participants agree to participate in the research and sign the informed consent form, this form is filled out by the researchers.All of these take approximately 15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr. Lütfi Kırdar City Hospital
Study officials:
affiliation: Supervisor
name: Dilek Coşkuner Potur, A. Professor
role: STUDY_DIRECTOR
References: