Effect of Vibration Anesthesia on Pain, Ecchymosis and Comfort Level in Subcutaneous Heparin Injection

NCT06662240 | Completed

• 2 other identifiers: 15653993494TYL-2023-12968
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of vibration anesthesia on injection pain, ecchymosis and comfort level in subcutaneous heparin injection.This study was conducted in a randomized controlled experimental design.

Conditions

Pain; Ecchymosis; Comfort

Keywords

pain; ecchymosis; comfort; vibration anesthesia; subcutaneous injection; nursing; heparin

Outcome Measures

Primary Outcomes (5)

• Ecchymosis Measurement Tool

  A transparent measuring tool was used to measure the ecchymosis at the injection site. The transparent measuring tool was placed on the ecchymosis and the borders of the ecchymosis were drawn with an acetate pen; then, the size of the ecchymosis was determined in mm2 by placing the transparent measuring tool on a millimeter measuring paper and recorded on the patient follow-up form. The size of the ecchymosis was measured at 48 hours after injection. It is reported that ecchymosis after subcutaneous heparin injection is most prominent after 48 hours. Based on the literature, discoloration smaller than 2 mm2 was considered as "no ecchymosis", and the size of discoloration of 2 mm2 or more was measured.

  7 months

• Patient Introduction Form

  It is a form prepared in line with the literature that includes the information of the patients (gender, age, marital status, educational status, employment status, body mass index, chronic disease, continuous medication use, smoking status).

  7 months

• Visual Analog Pain Scale

  The Visual Analog Scale (VAS) is a scale system used to convert some characteristics that cannot be quantitatively measured into numerical values. VAS pain was used to measure the intensity of pain during injection. The VAS pain scale is expressed as "0=No pain, 10=Unbearable pain" on a 10 cm horizontal line. Patients were asked to mark the intensity of pain experienced during subcutaneous injection with an X on the scale. It is a widely used valid scale.

  7 months

• Visual Analog Comfort Scale

  The VAS comfort is a 10 cm long horizontal measurement tool that starts with "most comfortable" and ends with "most uncomfortable". Patients rated their comfort level with this scale. For a better understanding of the term comfort by patients, they were asked to indicate their "comfort, satisfaction or level of comfort with the injection" on the scale. It is a valid scale widely used to assess comfort.

  7 months

• Patient Follow-up Form

  The patient follow-up form records the date and time of the injection, the patient's name or pseudonym, the group to which the patient belongs, the standard injection method with or without vibration, the injection site, pain intensity, comfort level and ecchymosis size.

  7 months

Study Arms (2)

Application of vibration anesthesia

EXPERIMENTAL

In addition to the routine injection protocol performed from the abdominal region, the vibration device was kept on the injection site by the investigator for 3 minutes just before the injection, the vibration device was removed from the injection site, and the injection was performed by the investigator immediately afterwards.

Device: The effect of vibration anesthesia on pain, ecchymosis and comfort level in subcutaneous heparin injection

Subcutaneous Heparin Injection without Vibration Anesthesia (Standard)

NO INTERVENTION

The patient will be informed about the procedure and consent will be obtained. Hands will be washed before the procedure and the abdomen, excluding the 5 cm2 area around the umbilicus, will be used for abdominal SC injection. During abdominal SC injections, the patient will be given a semi-fowler position that will be comfortable and does not complicate the injection, and the injection site will be cleaned with 70% alcohol cotton wool with circular movements from the center to the outside and left to dry. After the area dries, the skin and subcutaneous tissue in the injection area will be grasped between the thumb and index fingers. For injections, a 25 gauge, 1.26 cm needle length, air-locked, ready-to-use syringe containing DMAH (enoxaparin sodium) will be used to enter the tissue at a 90° angle, not aspiration will be performed, the drug will be applied for 10 seconds and the drug will be exited at a 90° angle.

Interventions

The effect of vibration anesthesia on pain, ecchymosis and comfort level in subcutaneous heparin injection DEVICE

The patient in the experimental group received one vibrating injection and one non-vibrating injection into the abdomen. The patient in the control group received 2 standard subcutaneous injections in the abdomen without vibration.

Application of vibration anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clexane (Enoxaparin Sodium) 0.6 ml SC 1x1 DMAH treatment (0.6 ml heparin was preferred because pain and ecchymosis may be less at a dose of 0.4 ml heparin and the incidence of pain and ecchymosis may increase at a dose of 0.8 ml Clexane .
• No cognitive, physical or mental impairment that prevented them from answering the questions,
• years of age or older,
• No previous known coagulation disorders,
• Platelet value between 150,000 and 300,000/millimeter cubed,
• PTZ value between 10-14 seconds,
• aPTT value between 20-40 seconds,
• INR value between 0.8-1.2,
• No incision, infection, ecchymosis, hematoma, scar tissue in the abdominal region
• No needle phobia
• Not taking pain medication in the last 12 hours
• No abdominal pain
• No other invasive procedures in the abdominal region
• SC heparin not administered by subcutaneous, intramuscular or intradermal injection,
• Patients with no known allergy to heparin,

You may not qualify if:

• The patient follow-up form records the date and time of the injection, the patient's name or pseudonym, the group to which the patient belongs, the standard injection method with or without vibration, the injection site, pain intensity, comfort level and ecchymosis size.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Meltem

Erzurum, yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Ecchymosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Skin Manifestations

Study Officials

• Meltem SIRIN GOK, Assistant Professor

  meltemsirin@atauni.edu.tr

  STUDY DIRECTOR

• Yaprak BAGA, Research Assistant

  yaprak.baga@atauni.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Each patient in the experimental and control groups received two subcutaneous injections. Each patient in the experimental group received one injection with vibration and one without vibration. Each patient in the control group received two injections without vibration. The purpose of administering two injections was to obtain control data within the experimental group by controlling individual factors related to the dependent variables of the study.

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: October 28, 2024
• Study Start: March 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: September 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)