NCT00122369

Brief Summary

Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and dread recurrent medical traumatization. The long-term objective of this research is to provide patients with a simple coping strategy at the vulnerable time of large core biopsy in the hope that this behavioral intervention will carry over to recovery and future medical procedures. In the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during percutaneous, image-guided vascular and renal interventions resulted in less pain and anxiety, greater hemodynamic stability, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. The investigators therefore challenge the current paradigms that long-lasting effects require intensive presurgical preparation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
7.6 years until next milestone

Results Posted

Study results publicly available

February 7, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

July 20, 2005

Results QC Date

February 3, 2012

Last Update Submit

February 23, 2013

Conditions

Breast CancerAnxietyPain

Keywords

BreastBiopsyHypnosisRelaxationAnxietyPainMedical and Surgical Procedures

Outcome Measures

Primary Outcomes (26)

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.

    0 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    10 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    20 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    30 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    40 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    50 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    60 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    70 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    80 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    90 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    100 min

  • Anxiety Ratings at Specified Time Point During the Procedure

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

    110 min

  • Time Trends of Anxiety Experience

    Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.

    0-110 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    0 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    10 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    20 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    30 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    40 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    50 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    60 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    70 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    80 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    90 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    100 min

  • Pain Ratings at Specified Time Point During the Procedure

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

    110 min

  • Time Trends of Pain Experience

    Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.

    0-110 min

Secondary Outcomes (2)

  • Salivary Cortisol Secretion

    Patients were followed for the 5 days following their breast biopsy

  • Impact of Event Scale (IES-15)

    Patients were followed for up to 3 weeks after their biopsy until the time of their surgery

Study Arms (3)

Self-hypnotic Relaxation

EXPERIMENTAL

A research assistant displayed defined behaviors of empathic attention and read to the patient a self-hypnotic relaxation script. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.

Behavioral: Self-hypnotic RelaxationBehavioral: Empathic Attention

Standard Care

NO INTERVENTION

Patients received the routine standard treatment which included application of lidocaine as local anesthetic. This is not considered a unique intervention in terms of the trial. Omitting local anesthetic actually would have been an intervention deviating from routine care.

Empathic Attention

ACTIVE COMPARATOR

A research assistant displayed defined behaviors of empathic attention. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.

Behavioral: Empathic Attention

Interventions

Self-hypnotic RelaxationBEHAVIORAL

A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.

Also known as: Comfort Talk®
Self-hypnotic Relaxation
Empathic AttentionBEHAVIORAL

A research assistant displayed defined behaviors of empathic attention.

Also known as: Empathy, Advanced Rapport Skills
Empathic AttentionSelf-hypnotic Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.

You may not qualify if:

  • Patients are excluded if :
  • They are unable to give informed consent, or pass screening for impaired mental function or psychosis.
  • They are unable to hear or understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • Lang EV, Berbaum KS, Lutgendorf SK. Large-core breast biopsy: abnormal salivary cortisol profiles associated with uncertainty of diagnosis. Radiology. 2009 Mar;250(3):631-7. doi: 10.1148/radiol.2503081087.

    PMID: 19244038RESULT

  • Lang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7.

    PMID: 16959427RESULT

MeSH Terms

Conditions

Breast NeoplasmsAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Title
Elvira V. Lang, MD
Organization
Beth Israel Deaconess Medical Center (at time of study); now Hypnalgesics, LLC
elang@bidmc.harvard.edu
978 404 9724

Study Officials

  • Elvira V Lang, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Former Associate Professor of Radiology

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

March 1, 2002

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

February 28, 2013

Results First Posted

February 7, 2013

Record last verified: 2013-02

Locations

US(1)