The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-blind, Randomized Cross-over Study

NCT04411992 | Unknown DMC

• 1 other identifier: 42432570
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Vibration; Pain management; satisfaction

Outcome Measures

Primary Outcomes (2)

• the effects of vibration on intramuscular injection-induced pain

  Pain will be measures with Visual Analog Scale (VAS). The scale is composed of a 10-cm vertical or horizontal line, which starts with "No pain" on the one edge and ends with "worst pain" on the other edge. Patients should be informed about the use of VAS very well. Patients are asked to indicate the pain level by marking the appropriate point on the line.

  Three months

• the effects of vibration on satisfaction for intramuscular injection

  patient satisfaction will be measured with Visual Analog Patient Satisfaction Scale .Visual patient satisfaction scale is combined with the characteristics of the well-known VAS (Visual Analog Scale). It is composed of a 100-mm horizontal line without numbers.

  Three months

Study Arms (4)

Allocated to Vibration intervention (1) A

EXPERIMENTAL

Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .

Device: Vibrating Device

Allocated to Control intervention (1) B

NO INTERVENTION

The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.

Allocated to Vibration intervention (2) B

EXPERIMENTAL

Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .

Device: Vibrating Device

Allocated to Control intervention (1) A

NO INTERVENTION

The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.

Interventions

Vibrating Device DEVICE

The device used for the vibration application was produced to control pain and distract attention by providing vibration of 150 at 183 Hz (9000-11,000/min). The device is used again by being cleaned with 70% alcohol. The device was placed put 3 cm above the injection site. It should be ensured to completely contact with skin. Vibration was applied on the site for 3 minutes before injection

Allocated to Vibration intervention (1) A; Allocated to Vibration intervention (2) B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

MeSH Terms

Conditions

Pain; Agnosia; Personal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All the measurement scores were obtained by another researcher blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 2, 2020
• Study Start: June 5, 2020
• Primary Completion: September 5, 2020
• Study Completion: September 10, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share