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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Helfer Skin Tap and Cold Application on Pain and Hemodynamics During Vaccination

NCT06976632

Pregnant Women

RECRUITING NA

The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns

NCT05079594

Pain, Acute

COMPLETED NA

Intervention for Fear of Childbirth in High-Risk Pregnant Women

NCT06716710

Threatened Premature Birth Premature Membrane Rupture Gestational Hypertension +4 more

COMPLETED NA

Skin-to-skin Contact for Newborn First Injection Pain

NCT05700552

Pain

COMPLETED NA

The Effect of Stress Ball Intervention During Non-Stress Test on Anxiety and Fetal Well-Being in High-Risk Pregnancy

NCT06302010

Anxiety Fetal Conditions Pregnancy Related

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Acute Alloimmunisation in Pregnancy Injection Site Injection Fear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Two intervention ,one control group

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anti-D Immunglobulin Injection with Cold Spray

Using cold spray before the Anti-D immunoglobulin injection

Group Type EXPERIMENTAL

Cold Spray

Intervention Type OTHER

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.

Anti-D Immunglobulin Injection with Manuel Pressure

Apply Manuel pressure before the Anti-D immunoglobulin injection

Group Type EXPERIMENTAL

Manuel Pressure

Intervention Type OTHER

Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.

Standard Anti-D Immunoglobulin Injection

Standard procedure for Anti-D immunglobulin injection

Group Type PLACEBO_COMPARATOR

Standard Injection Procedure

Intervention Type OTHER

Using any special method for injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Manuel Pressure

Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.

Intervention Type OTHER

Standard Injection Procedure

Using any special method for injection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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