Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04851158 |
| Other study ID # |
20210067 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2021 |
| Est. completion date |
May 30, 2021 |
Study information
| Verified date |
March 2023 |
| Source |
Istanbul Medeniyet University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In intramuscular injection applications, which are among the responsibilities and basic
skills of nurses, different methods are used to reduce the pain caused by injection and
increase the individual's satisfaction. ShotBlocker and local vibration are among the methods
used for this purpose. The aim of the study is to examine the effectiveness of ShotBlocker
and local vibration, which are among the non-pharmacological methods, on the perceived pain
and satisfaction during ventrogluteal intramuscular antibiotic injection.
This randomized, controlled experimental study will be carried out in the adult emergency
clinic of a training and research hospital in Istanbul between February and April 2021.
Description:
The purpose of study was to evaluate four research hypotheses as follows:
H1: Using ShotBlocker during intramuscular antibiotic injection reduces the patient's
injection pain.
H2: Using ShotBlocker during intramuscular antibiotic injection increases the patient's
satisfaction with the injection.
H3: Using a local vibrator device during intramuscular antibiotic injection reduces the
patient's injection pain.
H4: Using a local vibrator device during intramuscular antibiotic injection increases the
patient's satisfaction with the injection.
Sampling of the Research: The sample number was determined at the 0.5 effect size and 0.05
error level with the power analysis performed by taking into account the numerical values of
the findings obtained from a previous study on this subject. ShotBlocker group: 35; Local
vibration group: 35, Control Group: 35 people.
The sample of the study will consist of volunteer patients who apply to the adult emergency
department, who are administered antibiotics (amoxicillin / cefuroxime sodium) upon the
physician's request, and who meet the inclusion criteria.
Data Collection Tools: Research data will be collected using the Structured Information Form
created by the researchers, VAS Pain and VAS Satisfaction Scales.
Structured Information Form; Five questions regarding the descriptive characteristics of the
participants (age, gender, body mass index (BMI), educational status, marital status) were
included. BMI (kg/m2) of the participants will be calculated by the researcher.
Procedure:
1. Initial Assessment:
Verbal information will be given to the participants and their written consents will be
obtained prior to the intramuscular injection. The "Structured Information Form"
consisting of five questions will be applied by face to face interview method, BMI will
be calculated by measuring height and weight and recorded in the "Structured Information
Form".
ShotBlocker is a patented tool developed by Bionix (Toledo, OH, United States). It is a
small, flat, horseshoe (U-shaped) shaped plastic tool with a thickness of 2 mm, which is
used for pain control in intramuscular and subcutaneous injections, suitable for all age
groups, has no known side effects, does not have drug properties, is non-invasive. Since
it is not an invasive device, it is stated by the manufacturer that it can be used
several times for the same patient after washing with soap. The protruding surface of
the vehicle is placed in the area to be applied just before injection. Short blunt bumps
on the surface of the vehicle do not pierce the skin.
Local Vibrator one of the electric vibrator devices (dolphin massager device, 210-240 V,
50 Hz) produced by different brands was used. These devices with interchangeable heads
have the ability to affect deep muscle groups, stimulate nerve endings and accelerate
blood circulation thanks to mechanical vibration. During application, the device must be
in full contact with the skin. Local vibration application reduces perceived pain by
stimulating nerve fibers according to Melzack and Wall's Gate Control Theory.
2. Application:
Before the drug is prepared, the physician's request will be checked by the researcher.
Hands will be washed, the drug (amoxicillin / cefuroxime sodium) will be prepared by
diluting with 4 ml of water for injection, the needle tip will be changed to 21G
(0.8x40mm - green). The patient will be verbally informed, and the drug allergy status
will be questioned. The patient will be asked to lie down in the prone position. The
skin surface in the area where the IM injection will be applied will be observed by the
researching specialist nurse for ecchymosis, scar, inflammation or edema. The presence
of tenderness or stiffness will be evaluated by palpation, paying attention to muscle
integrity. To the patient group who was applied local vibration; Before injection, local
vibration will be applied to the region with a vibrator for five minutes, guided by a
previous study on this subject. Afterwards, the skin will be cleaned using 70% alcohol
and the injection will be applied with the appropriate technique, and then a light
pressure will be applied to the area with a cotton pad for 15-20 seconds. For the
patient group treated with ShotBlocker; After skin cleaning, the protruding surface of
the vehicle will be placed facing the skin surface and the injection will be applied
with the appropriate technique, then ShotBlocker will be removed and a light pressure
will be applied to the area with a cotton pad for 15-20 seconds. In the control group;
IM injection into the ventrogluteal area will be performed with the appropriate
technique without using any tools.
3. Final Assessment:
The change from baseline in pain and satisfaction scores on the Visual Analogue Scale (VAS)
will be measured immediately after intramuscular injection using VAS.
Ethical Considerations: The ethical compliance of the study was approved by the Istanbul
Medeniyet University Goztepe Training and Research Hospital clinical research ethics
committee (date and number: 10.02.2021/0067). Written institutional permission was obtained.
After the purpose and duration of the study is explained, written informed consent is
obtained from the patients on a voluntary basis.
Statistical Analyses: Data will be analyzed using SPSS (Statistical Package for Social
Sciences, Chicago, Illinois) version 16.0.
Note: The research is not supported by any institution or organization.
