The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection

NCT05686148 | Unknown

• 1 other identifier: Vibration Subcutaneous inj
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This study was needed to relieve the pain associated with subcutaneous injection, which is an application performed by nurses, to increase patient satisfaction, to increase patient compliance with treatment, and to strengthen positive patient-nurse communication. The purpose of this study is to assess the effect of vibration stimulation application on subcutan injection induced pain and patient satisfaction. The study will be carried out in the internal medicine service of a university hospital. Vibration will be applied during subcutaneous injection of anticoagulant to one group, but not to the other group. It was planned to include 85 patients in the study.

Conditions

Pain

Keywords

Acute Pain; Personal Satisfaction; Injections, Subcutaneous

Outcome Measures

Primary Outcomes (5)

• Patient Information Form

  It includes some socio-demographic characteristics of the individual (age, gender, place of residence, marital status, educational status, employment status).

  day 1

• Visual Analog Scale

  Scale, 10 cm long, horizontal or vertical; It consists of a line starting with "No Pain" and ending with "Unbearable Pain". The use of VAS should be explained to the patient very well. The patient is asked to indicate the severity of the pain with a sign on this line where he deems appropriate. The distance between the onset of no pain and this point is measured in cm and recorded. Values range from 0 to 10, and patients' pain levels are evaluated over 10 points as 0 = no pain, 10 = unbearable pain.

  day 1

• Visual Analog Scale

  Scale, 10 cm long, horizontal or vertical; It consists of a line starting with "No Pain" and ending with "Unbearable Pain". The use of VAS should be explained to the patient very well. The patient is asked to indicate the severity of the pain with a sign on this line where he deems appropriate. The distance between the onset of no pain and this point is measured in cm and recorded. Values range from 0 to 10, and patients' pain levels are evaluated over 10 points as 0 = no pain, 10 = unbearable pain.

  day 2

• Visual Patient Satisfaction Scale

  The visual patient satisfaction scale combines with the features of the well-known VAS (Visual Analogue Scale). It consists of a 100 mm horizontal line without numbers. At one end of the line is the phrase "I am not satisfied at all" and at the other end is the statement "Very satisfied". The patient must synthesize all the components that affect him in relation to the medical care given, determine the state of satisfaction he is in and find the point on the line that corresponds to his situation.

  day 1

• Visual Patient Satisfaction Scale

  The visual patient satisfaction scale combines with the features of the well-known VAS (Visual Analogue Scale). It consists of a 100 mm horizontal line without numbers. At one end of the line is the phrase "I am not satisfied at all" and at the other end is the statement "Very satisfied". The patient must synthesize all the components that affect him in relation to the medical care given, determine the state of satisfaction he is in and find the point on the line that corresponds to his situation.

  day 2

Study Arms (2)

Intervention

EXPERIMENTAL

Vibration will be applied to the injection site for 5 minutes before the procedure.

Other: Vibration

Control

NO INTERVENTION

No application will be made

Interventions

Vibration OTHER

The device used for vibration application is produced to control pain and direct attention by providing 6000/min vibration. According to Melzack and Wall's Gate Control Theory, the application of local vibration reduces perceived pain by stimulating nerve fibers. Therefore, it should be ensured that the device is in full contact with the skin. The device can be used again by wiping with 70% alcohol. The device is placed 3 cm above the area to be injected. Vibration is applied to the area for 5 minutes before the procedure.

Intervention

Eligibility Criteria

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

You may qualify if:

• Volunteers aged 18 and over,
• are conscious and have no communication problems,
• body mass index (BMI) of 18.5 to 30kg/m2,
• who have not had an injection in the last two weeks in the area to be injected subcutaneously,
• no signs of skin pain, hematoma, necrosis, scarring, incision or infection at the subcutaneous injection site,
• patients treated with subcutaneous heparin injection therapy

You may not qualify if:

• patients not receiving heparin injection therapy

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Acute Pain; Personal Satisfaction

Interventions

Vibration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All of the outcomes results were obtained by another researcher blinded to group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 17, 2023
• Study Start: September 20, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 30, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

TU (1)