Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-12 @ 10:42 AM
Study NCT ID:
NCT04411992
Status:
UNKNOWN
Last Update Posted:
2020-06-02
First Post:
2020-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-blind, Randomized Cross-over Study
Sponsor:
Istanbul Medeniyet University
Organization:
Study Overview
Official Title:
The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-Blind, Randomized Cross-over Study
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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?
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: