Trial Outcomes & Findings for Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients (NCT NCT03619135)

NCT ID: NCT03619135

Last Updated: 2019-02-05

Results Overview

Pain is measured on a 10 point visual analog scale with 0 being no pain and 10 being the worst pain imaginable. A higher score is a worse outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Baseline and after IV access
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	Use of Buzzy Device The Buzzy device was used for IV access for this arm. Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.	Control No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques)
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Use of Buzzy Device n=50 Participants The Buzzy device was used for IV access for this arm. Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.	Control n=50 Participants No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques)	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants	50 Participants n=50 Participants	100 Participants n=100 Participants
Age, Categorical >=65 years	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=100 Participants
Sex: Female, Male Female	29 Participants n=50 Participants	26 Participants n=50 Participants	55 Participants n=100 Participants
Sex: Female, Male Male	21 Participants n=50 Participants	24 Participants n=50 Participants	45 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: Baseline and after IV access

Pain is measured on a 10 point visual analog scale with 0 being no pain and 10 being the worst pain imaginable. A higher score is a worse outcome.

Outcome measures

Measure	Use of Buzzy Device n=50 Participants The Buzzy device was used for IV access for this arm. Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.	Control n=50 Participants No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques)
Change in Pain	1.55 score on a scale Standard Deviation 1.119	1.76 score on a scale Standard Deviation 1.401

PRIMARY outcome

Timeframe: Baseline and after IV access

Anxiety is measured on a 10 point visual analog scale with 0 being no anxiety and 10 being the worst anxiety imaginable. A higher score is a worse outcome.

Outcome measures

Measure	Use of Buzzy Device n=50 Participants The Buzzy device was used for IV access for this arm. Buzzy: The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.	Control n=50 Participants No Buzzy device was used - standard IV access for this arm. Placebo: No use of the Buzzy (standard IV access techniques)
Change in Anxiety	1.70 score on a scale Standard Deviation 1.743	1.84 score on a scale Standard Deviation 1.796

Adverse Events

Use of Buzzy Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kyle Stein

University of Iowa College of Dentistry

Phone: 319-384-5105

Email: kyle-stein@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place