The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection
NCT ID: NCT05686148
Last Updated: 2023-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
85 participants
INTERVENTIONAL
2022-09-20
2023-01-30
Brief Summary
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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.
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Detailed Description
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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 conducted between September 2022 and January 2023 in the internal medicine ward of a university hospital in Istanbul/Turkey in a prospective, randomized, single-blind, crossover design.Two groups will be formed according to the crossover order. Volunteers will be informed about the study and their written consent will be obtained. Patient evaluation form, visual pain form and satisfaction scale will be applied to all patients before injection. The height, weight and body mass index of the patients will be measured by the specialist nurse. An anticoagulant will be administered subcutaneously over the abdominal region. The areas to be injected will be determined in the same way for each patient. Low molecular weight heparin will be administered subcutaneously to the umbilical region with and without vibration, with an interval of 24 hours. All patients will be injected with the same investigative nurse, following the standard procedure. 5 minutes after the application, the pain and satisfaction level of all patients will be evaluated using scales. Vibration application will be applied by the researchers for 5 minutes before the injection application.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention
Vibration will be applied to the injection site for 5 minutes before the procedure.
Vibration
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.
Control
No application will be made
No interventions assigned to this group
Interventions
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Vibration
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Istanbul Aydın University
OTHER
Responsible Party
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DİLEK YILDIRIM
Assistant Prof.
Locations
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Istanbul Aydin University
Istanbul, , Turkey (Türkiye)
Countries
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Facility Contacts
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Other Identifiers
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Vibration Subcutaneous inj
Identifier Type: -
Identifier Source: org_study_id
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