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Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

This study has been completed.
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Elvira Lang, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00122369
First received: July 20, 2005
Last updated: February 23, 2013
Last verified: February 2013
History of Changes
Results First Received: February 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Breast Cancer
Anxiety
Pain
Interventions: Behavioral: Self-hypnotic Relaxation
Behavioral: Empathic Attention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 2002 and March 2004, 240 eligible patients were recruited and randomly assigned to treatments. Four patients (including the only male) withdrew after entering the biopsy suite before starting with the intervention in the Intervention Groups or data collection in the Standard Care Group.

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
Standard of Care As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
Empathic Attention The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
Self-Hypnotic Relaxation In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.

Participant Flow:   Overall Study
    Standard of Care     Empathic Attention     Self-Hypnotic Relaxation  
STARTED     76     82     78  
COMPLETED     76     82     78  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Standard of Care As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
Empathic Attention The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
Self-Hypnotic Relaxation In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
Total Total of all reporting groups

Baseline Measures
    Standard of Care     Empathic Attention     Self-Hypnotic Relaxation     Total  
Number of Participants  
[units: participants]
 		  76     82     78     236  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     69     74     73     216  
>=65 years     7     8     5     20  
Age  
[units: years]
Mean ± Standard Deviation 		  49.2  ± 13.4     48.0  ± 13.22     47.8  ± 13.7     48.3  ± 13.4  
Gender  
[units: participants]
 		       
Female     76     82     78     236  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     76     82     78     236  



  Outcome Measures
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1.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 0 min ]
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2.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 10 min ]
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3.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 20 min ]
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4.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 30 min ]
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5.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 40 min ]
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6.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 50 min ]
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7.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 60 min ]
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8.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 70 min ]
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9.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 80 min ]
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10.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 90 min ]
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11.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 100 min ]
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12.  Primary:   Anxiety Ratings at Specified Time Point During the Procedure   [ Time Frame: 110 min ]
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13.  Primary:   Time Trends of Anxiety Experience   [ Time Frame: 0-110 min ]
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14.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 0 min ]
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15.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 10 min ]
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16.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 20 min ]
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17.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 30 min ]
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18.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 40 min ]
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19.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 50 min ]
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20.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 60 min ]
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21.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 70 min ]
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22.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 80 min ]
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23.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 90 min ]
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24.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 100 min ]
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25.  Primary:   Pain Ratings at Specified Time Point During the Procedure   [ Time Frame: 110 min ]
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26.  Primary:   Time Trends of Pain Experience   [ Time Frame: 0-110 min ]
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27.  Secondary:   Salivary Cortisol Secretion   [ Time Frame: Patients were followed for the 5 days following their breast biopsy ]
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28.  Secondary:   Impact of Event Scale (IES-15)   [ Time Frame: Patients were followed for up to 3 weeks after their biopsy until the time of their surgery ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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
For the assessment of the Secondary Outcome parameter we were able to recruit only 19 women whom we could contact early enough on the day of their breast cancer surgery to fill out the IES. This limits the power of the statistical analysis.  


Results Point of Contact:  
Name/Title: Elvira V. Lang, MD
Organization: Beth Israel Deaconess Medical Center (at time of study); now Hypnalgesics, LLC
phone: 978 404 9724
e-mail: elang@bidmc.harvard.edu


Publications of Results:


Responsible Party: Elvira Lang, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00122369     History of Changes
Other Study ID Numbers: DAMD 17-01-1-0153, 2001P-001681
Study First Received: July 20, 2005
Results First Received: February 3, 2012
Last Updated: February 23, 2013
Health Authority: United States: Institutional Review Board