Clinical Trials Directory

Trials / Unknown

UnknownNCT05686148

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

The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection: A Randomized Crossover Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
85 (estimated)
Sponsor
Istanbul Aydın University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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 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

Interventions

TypeNameDescription
OTHERVibrationThe 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.

Timeline

Start date
2022-09-20
Primary completion
2023-01-15
Completion
2023-01-30
First posted
2023-01-17
Last updated
2023-01-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05686148. Inclusion in this directory is not an endorsement.