Clinical trial NCT04411992: The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-blind, Randomized Cross-over Study
Official title: The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-Blind, Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Vibration
Pain management
satisfaction
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two groups were formed according to crossover design. The groups of the patients were determined according to the randomization list formed by using the following website; www.randomization.com.All the measurement scores were obtained by another researcher blinded to group allocation.
Primary purpose: PREVENTION

Brief summary: Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16 billion treatments are performed through injection per year all over the world. Approximately 95% of these injections are administered for therapeutic purpose. There is no study result in the literature on the effect of vibration on pain in the ventrogluteal region in particular.

Detailed description: Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16 billion treatments are performed through injection per year all over the world. Approximately 95% of these injections are administered for therapeutic purpose.

If IM injections are not administered properly, they cause many complications such as primarily pain and cellulitis, muscular fibrosis and contracture, abscesses, tissue necrosis, granuloma, hematoma, and nerve injuries.Painful injections may lead to the development of fear and needle phobia. People are not able to comply with the treatment due to fear and needle phobia and they may even reject treatment. Pain developing after IM injection may vary based on drug content, individual factors and injection technique.

It has been reported that patients feel less pain and the other complications decrease when the correct technique of IM injection is selected. Different pain relief methods such as local ice application, changing needle before injection and acupressure are employed during injection. In the literature, mechano-analgesia, which is known as the skin stimulation methods, is included in pain management in addition to these methods.

One of the mechano-analgesia methods is vibration. The pain-relief mechanism of vibration is explained with the gate control theory. The theory, which is a similar mechanism used to obtain pain relief by rubbing an area near an injury, using TENS, or acupuncture. In the studies, it has been explained by the fact that the sense of touch and vibration obtained from skin receptors stimulate the intermediary inhibitor neurons in medulla spinalis through A-β nerve fibres. These neurons reduce the pain level in A-delta and A-C fibres in transmitting the signal received from skin to the second neuron, the signal cross over medulla spinalis and rises to brain. There are studies in the literature explaining that pain is reduced by vibration. Also, the vibration has advantages over other methods such as TENS, acupuncture as it is a method that is easy to apply, simple, applicable in all hours, and cheap and does not require any preparation.

Although the results of the related studies have indicated that this new method is effective in reducing injection pain, the number of studies on this method in the literature is limited. There is no study result in the literature on the effect of vibration on pain in the ventrogluteal region in particular.

Purpose of the study The purpose of this study was to assess the effect of vibration stimulation application in ventrogluteal region on intramuscular injection pain and patient satisfaction.

The specific study questions were as follows:

1. What are the effects of vibration on intramuscular injection-induced pain?
2. What are the effects of vibration on satisfaction for intramuscular injection?

Eligibility criteria: Inclusion Criteria:

* 18 years old and over
* had no communication problem,
* had a body mass index (BMI) of 18.5 to 30 kg/m2,
* not injected in ventrogluteal region in the last two weeks
* not have any pain, hematoma, necrosis, scar, incision or infection symptoms on skin in ventrogluteal region

Exclusion Criteria:

* Have ppain, hematoma, necrosis, scar, incision or infection symptoms on skin in ventrogluteal region
* injected in ventrogluteal region in the last two weeks
* not want to participate.
* body mass index (BMI) of under 18.5 and up 30 kg/m2,
* have psychological illness

Primary outcomes:
measure: the effects of vibration on intramuscular injection-induced pain
timeFrame: Three months
measure: the effects of vibration on satisfaction for intramuscular injection
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: