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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00122369
• Other study ID #: DAMD 17-01-1-0153
• Secondary ID: 2001P-001681
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2005
• Last updated: February 23, 2013
• Start date: March 2002
• Est. completion date: March 2004

Study information

• Verified date: February 2013
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Large core image-guided breast biopsy is a well established tool for diagnosing breast cancer. Using ultrasound or X-ray guidance, a large hollow needle is inserted through the skin into the breast and abnormal tissue is removed for diagnosis. Although this procedure is much less invasive than open surgery, it can induce pain and anxiety that can tax the coping mechanism of even the highest functioning individuals. Unrelieved stress during a medical procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and feel dread in anticipation. The long-term objective of this research is to provide patients with a simple coping strategy at the time of large core biopsy, when they need it most. The hope is that this newly learned ability to handle distress will carry over to recovery and to future medical procedures. In a prior clinical trial (Lancet 2000:335:1486-1489), the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during image-guided interventions of the blood vessels and the kidneys resulted in less pain and anxiety, fewer worrisome increases and decreases of blood pressure and heart rate, 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. Based on these past findings, the researchers therefore predict to show evidence contrary to the current thinking that long-lasting effects require intensive presurgical preparation.

The researchers propose to pursue three interrelated specific aims:

• (Aim 1): Determine the acute effects of self-hypnotic relaxation on pain and anxiety. Strictly defined methods of self-hypnotic relaxation (Group I), will be tested against empathic attention (Group II) and the routine standard of care (Group III) in a prospective randomized study with 240 patients undergoing large core breast biopsy. The impact of the treatment will be validated by comparing during the procedure among groups subjective measures of pain and anxiety as well as objective physiologic indicators of pain and anxiety (frequency of significant increases in heart rate and blood pressure).

• (Aim 2): Determine the delayed effects of self-hypnotic relaxation. Patients' levels of pain, anxiety, and stress will be recorded through days 1-5 after the biopsy and compared among groups. Stress levels measurements will be based on an objective test (the amount of the stress hormone cortisol in the patient's saliva).

• (Aim 3): Determine the effect of the initial self-hypnotic relaxation on distress with upcoming subsequent surgery in women with proven breast cancer. When patients have to return for surgery because their biopsy revealed malignant cells, they will be given questionnaires assessing their degree of perceived stress , anxiety, and preoccupation with their upcoming surgery. Comparison among groups will show the durability of the initial hypnotic intervention.

The researchers hypothesize that:

• Self-hypnotic relaxation reduces pain and anxiety during large core breast biopsy

• Self-hypnotic relaxation at the time of biopsy reduces post-biopsy stress

• Teaching patients coping skills at the critical time of the breast biopsy reduces the patients' distress with upcoming breast surgery.

Upon completion, a short periprocedural self-hypnotic intervention will be validated by rigorous and practical assessment in 240 patients. The relative performance of self-hypnotic relaxation will be known compared to standard care and empathic controls in a well-characterized population of patients with a standardized biopsy wound. The durability of an intervention given at the earliest possible moment of breast cancer diagnosis will be established. This opens the way to future study designs addressing long-term effects on health behavior and psycho-physiologic phenomena.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Pain

Intervention

Behavioral:
• Self-hypnotic Relaxation
A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.
• Empathic Attention
A research assistant displayed defined behaviors of empathic attention.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Salivary Cortisol Secretion	Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.	Patients were followed for the 5 days following their breast biopsy	No
Secondary	Impact of Event Scale (IES-15)	The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75.; =26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy	Patients were followed for up to 3 weeks after their biopsy until the time of their surgery	No