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

June 4, 2024 updated by: Gulsum Coskun

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Kartal Dr. Lütfi Kırdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anti-D Immunglobulin Injection with Cold Spray
Using cold spray before the Anti-D immunoglobulin injection
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.
Experimental: Anti-D Immunglobulin Injection with Manuel Pressure
Apply Manuel pressure before the Anti-D immunoglobulin injection
Other: Manuel Pressure
Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.
Placebo Comparator: Standard Anti-D Immunoglobulin Injection
Standard procedure for Anti-D immunglobulin injection
Other: Standard Injection Procedure
Using any special method for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Approximately 3 minute after injection
Visual Analog Scale will be used to measure the injection pain intensity in pregnant women receiving the Human Immunoglobulin Anti-D injection. Participants in the study will be asked to mark their own pain level on a 10 cm ruler with "no pain" at one end and "unbearable pain" at the other. The preference for using VAS in pain intensity measurement is due to its ability to provide a numerical and replicable measurement according to the purpose.
Approximately 3 minute after injection
Injection Satisfaction
Time Frame: Approximately 4 minute after injection
When reviewing the literature, no specific scale for assessing satisfaction with IM injection applications was found. Upon examining national and international studies assessing satisfaction with IM injection, it was determined that VAS was utilized.In order to assess the satisfaction of patients after the injection, a scale with a vertical line of 10 cm, with "Very Satisfied" at one end and "Not Satisfied at All" at the other end, will be used. The selection of this scale is primarily influenced by its similarity to VAS and its ease of understanding and marking. The use of a vertical dimension is deemed appropriate for better clarity.
Approximately 4 minute after injection
Pain Fear
Time Frame: Before injection
The Pain Fear Scale III was developed by McNeil and Rainwater to measure fear and/or anxiety related to pain. Ünver and Turan conducted a Turkish validity and reliability study for the scale. The scale consists of three subscales, each with 10 items. The subscales and their respective items are listed. In evaluating the scale without reverse scoring, items are rated on a Likert-type scale ranging from 1 to 5 (1-Never, 2-Slightly, 3-Fairly, 4-Very, 5-Extremely). The minimum total score is 30, and the maximum total score is 150. For each subscale, the minimum score is 10, and the maximum score is 50. A higher score on the scale indicates higher pain fear.
Before injection
Introductory Information Form
Time Frame: 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.
The form prepared by the researcher, based on literature information, consists of a total of 10 questions related to the socio-demographic characteristics (age, height, weight, employment status, education level, job, blood type) and obstetric characteristics (last menstrual period, gravida , miscarriage, abortion, parity, type of delivery and previous use of Human Immunoglobulin Anti-D injection) of pregnant women prescribed with Human Immunoglobulin Anti-D injection. The same form will be used for recording the hemodynamic parameters (pulse rate, blood pressure, respiratory rate, and oxygen saturation) of pregnant women before and after the injection, which will be measured by the researcher.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulsum Coskun

Investigators

  • Study Director: Dilek Coşkuner Potur, A. Professor, supervisor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kartalsehir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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