Clinical trial NCT05686148: The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection
Official title: The Effect of Vibration Application on Pain and Satisfaction Associated With Subcutaneous Anticoagulation Injection: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Acute Pain
Personal Satisfaction
Injections, Subcutaneous
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* patients not receiving heparin injection therapy

Primary outcomes:
measure: Patient Information Form
timeFrame: day 1
measure: Visual Analog Scale
timeFrame: day 1
measure: Visual Analog Scale
timeFrame: day 2
measure: Visual Patient Satisfaction Scale
timeFrame: day 1
measure: Visual Patient Satisfaction Scale
timeFrame: day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
References: