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

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06231719
• Other study ID #: Kartalsehir
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: June 2024
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: July 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Injection Site
• Pain, Acute

Intervention

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.
• Manuel Pressure
Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.
• Standard Injection Procedure
Using any special method for injection

Locations

Country	Name	City	State
Turkey	Kartal Dr. Lütfi Kirdar City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gulsum Coskun

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	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
Primary	Injection Satisfaction	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
Primary	Pain Fear	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
Primary	Introductory Information Form	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.

External Links

•   Detailed Information About Injection