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Trial record 1 of 1 for:    NCT01695993
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Alternative Approaches for Nausea Control

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ClinicalTrials.gov Identifier: NCT01695993
Recruitment Status : Completed
First Posted : September 28, 2012
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Nausea
Interventions: Device: Acupressure bands
Other: Expectancy-neutral handout
Behavioral: Expectancy-neutral MP3
Other: Expectancy-enhancing handout
Behavioral: Expectancy-enhancing MP3

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1 Patients will receive only the handout without the expectancy enhancing component
Arm 2

Handout without expectancy- enhancing component

  • Relaxation MP3 without expectancy-enhancing component
  • Acupressure bands
Arm 3
  • Handout with expectancy- enhancing component
  • Relaxation MP3 with expectancy- enhancing component
  • Acupressure bands

Participant Flow:   Overall Study
    Arm 1   Arm 2   Arm 3
STARTED   81   80   81 
COMPLETED   76   75   75 
NOT COMPLETED   5   5   6 
Lost to Follow-up                2                1                3 
Withdrawal by Subject                2                2                2 
To ill to continue                1                2                0 
Changed Medical Facility                0                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1 Patients will receive only the handout without expectancy enhancing component
Arm 2
  • Handout without expectancy- enhancing component
  • Relaxation MP3 without expectancy-enhancing component
  • Acupressure bands
Arm 3
  • Handout with expectancy- enhancing component
  • Relaxation MP3 with expectancy- enhancing component
  • Acupressure bands
Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Arm 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   75   75   226 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.2  (11.5)   53.2  (11.6)   52.6  (10.5)   53  (11.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      76 100.0%      75 100.0%      75 100.0%      226 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      3   3.9%      1   1.3%      1   1.3%      5   2.2% 
Not Hispanic or Latino      73  96.1%      74  98.7%      73  97.3%      220  97.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   1.3%      1   0.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      1   1.3%      1   1.3%      2   0.9% 
Asian      2   2.6%      1   1.3%      1   1.3%      4   1.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7   9.2%      6   8.0%      6   8.0%      19   8.4% 
White      67  88.2%      66  88.0%      66  88.0%      199  88.1% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   1.3%      1   1.3%      2   0.9% 
Region of Enrollment 
[Units: Participants]
       
United States   76   75   75   226 


  Outcome Measures

1.  Primary:   Patient Report Nausea Diary   [ Time Frame: five days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joseph A. Roscoe, PhD Associate Research Professor
Organization: University of Rochester Medical Center
phone: 585 275-9962
e-mail: joseph_roscoe@urmc.rochester.edu



Responsible Party: Joseph Roscoe, University of Rochester
ClinicalTrials.gov Identifier: NCT01695993     History of Changes
Other Study ID Numbers: UCCS1202
R01AT007474-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2012
First Posted: September 28, 2012
Results First Submitted: March 27, 2018
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018