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Effectiveness of External Vibration for Pain Relief During Intravenous Access in Adult Patients

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ClinicalTrials.gov Identifier: NCT03619135
Recruitment Status : Completed
First Posted : August 7, 2018
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Stein, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pain Management
Anxiety
Interventions Device: Buzzy
Other: Placebo
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Use of Buzzy Device Control
Hide Arm/Group Description

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.

No Buzzy device was used - standard IV access for this arm.

Placebo: No use of the Buzzy (standard IV access techniques)

Period Title: Overall Study
Started 50 50
Completed 50 50
Not Completed 0 0
Arm/Group Title Use of Buzzy Device Control Total
Hide Arm/Group Description

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.

No Buzzy device was used - standard IV access for this arm.

Placebo: No use of the Buzzy (standard IV access techniques)

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
50
 100.0%
50
 100.0%
100
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
29
  58.0%
26
  52.0%
55
  55.0%
Male
21
  42.0%
24
  48.0%
45
  45.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 100 participants
50 50 100
1.Primary Outcome
Title Change in Pain
Hide Description 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.
Time Frame Baseline and after IV access
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Use of Buzzy Device Control
Hide Arm/Group Description:

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.

No Buzzy device was used - standard IV access for this arm.

Placebo: No use of the Buzzy (standard IV access techniques)

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.55  (1.119) 1.76  (1.401)
2.Primary Outcome
Title Change in Anxiety
Hide Description 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.
Time Frame Baseline and after IV access
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Use of Buzzy Device Control
Hide Arm/Group Description:

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.

No Buzzy device was used - standard IV access for this arm.

Placebo: No use of the Buzzy (standard IV access techniques)

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.70  (1.743) 1.84  (1.796)
Time Frame The entirety of the study for each patient. This was approximately 5 minutes for the IV access (portion involving the research) and approximately 60 minutes for the total surgical procedure.
Adverse Event Reporting Description No adverse events were encountered.
 
Arm/Group Title Use of Buzzy Device Control
Hide Arm/Group Description

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.

No Buzzy device was used - standard IV access for this arm.

Placebo: No use of the Buzzy (standard IV access techniques)

All-Cause Mortality
Use of Buzzy Device Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Use of Buzzy Device Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Use of Buzzy Device Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kyle Stein
Organization: University of Iowa College of Dentistry
Phone: 319-384-5105
EMail: kyle-stein@uiowa.edu
Layout table for additonal information
Responsible Party: Kyle Stein, University of Iowa
ClinicalTrials.gov Identifier: NCT03619135     History of Changes
Other Study ID Numbers: 201601806
First Submitted: August 2, 2018
First Posted: August 7, 2018
Results First Submitted: November 15, 2018
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019