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

NCT06231719 | Active Not Recruiting

• 1 other identifier: Kartalsehir
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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.

Study Arms (3)

Anti-D Immunglobulin Injection with Cold Spray

EXPERIMENTAL

Using cold spray before the Anti-D immunoglobulin injection

Other: Cold Spray

Anti-D Immunglobulin Injection with Manuel Pressure

EXPERIMENTAL

Apply Manuel pressure before the Anti-D immunoglobulin injection

Other: Manuel Pressure

Standard Anti-D Immunoglobulin Injection

PLACEBO COMPARATOR

Standard procedure for Anti-D immunglobulin injection

Other: Standard Injection Procedure

Interventions

Cold Spray 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 Cold Spray

Manuel Pressure OTHER

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

Anti-D Immunglobulin Injection with Manuel Pressure

Standard Injection Procedure OTHER

Using any special method for injection

Standard Anti-D Immunoglobulin Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gulsum Coskun: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

Related Links

• Detailed Information About Injection

MeSH Terms

Conditions

Acute Pain; Iatrophobia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Coşkuner Potur, A. Professor

  Supervisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator Nurse

Model Details: Two intervention ,one control group

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 30, 2024
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 30, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)