Breast CancerPhase 2NCT00122369
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
A Phase 2 study testing Self-hypnotic Relaxation and Empathic Attention in people with Breast Cancer and Anxiety, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Anxiety, Pain
- What is being tested?
- Self-hypnotic Relaxation and Empathic Attention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Mar 2004
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the detailed 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.
- Conditions
- Breast Cancer, Anxiety, Pain
- Being tested
- Self-hypnotic Relaxation, Empathic Attention
- Keywords
- Breast, Biopsy, Hypnosis, Relaxation, Anxiety, Pain, Medical and Surgical Procedures
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnotic RelaxationBehavioural
Also called Comfort Talk®
A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.
Empathic AttentionBehavioural
Also called Empathy, Advanced Rapport Skills
A research assistant displayed defined behaviors of empathic attention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Self-hypnotic Relaxation; Behavioral: 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. Receives: Behavioral: Empathic Attention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 0-110 min
Secondary outcomes (2)
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.
Measured: Patients were followed for the 5 days following their breast biopsy
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
Measured: Patients were followed for up to 3 weeks after their biopsy until the time of their surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startMar 2002
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Elvira Lang, Beth Israel Deaconess Medical Center
- Investigators
- Elvira V Lang, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122369
- Sponsor's protocol ID
- DAMD 17-01-1-0153
- Other IDs
- 2001P-001681
- Status last verified
- Feb 2013
- First submitted
- 20 Jul 2005
- Last updated
- 28 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19244038Lang 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.
PubMed 16959427
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
- ClinicalTrials.gov ID
- NCT00122369
- Acronym / sponsor ID
- DAMD 17-01-1-0153
- Conditions
- Breast Cancer, Anxiety, Pain
- Keywords
- Breast, Biopsy, Hypnosis, Relaxation, Anxiety, Pain, Medical and Surgical Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Posted 7 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-hypnotic Relaxation | Experimental | Behavioral: Self-hypnotic Relaxation, Behavioral: Empathic AttentionA 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. |
| 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 | Behavioral: Empathic AttentionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.
Key exclusion criteria (3 listed)
- They are unable to give informed consent, or pass screening for impaired mental function or psychosis.
- They are unable to hear or understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnotic RelaxationAlso: Comfort Talk®A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention. | Behavioural | Self-hypnotic Relaxation |
| Empathic AttentionAlso: Empathy, Advanced Rapport SkillsA research assistant displayed defined behaviors of empathic attention. | Behavioural | Empathic Attention, Self-hypnotic Relaxation |
Primary outcome
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 0 min
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.
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 10 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 20 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 30 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 40 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 50 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 60 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 70 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 80 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 90 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 100 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Anxiety Ratings at Specified Time Point During the Procedure
Time frame: 110 min
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Trends of Anxiety Experience
Time frame: 0-110 min
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.
Pain Ratings at Specified Time Point During the Procedure
Time frame: 0 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 10 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 20 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 30 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 40 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 50 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 60 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 70 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 80 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 90 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 100 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Pain Ratings at Specified Time Point During the Procedure
Time frame: 110 min
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Trends of Pain Experience
Time frame: 0-110 min
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.
2 secondary outcomes
Salivary Cortisol Secretion
Time frame: Patients were followed for the 5 days following their breast biopsy
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19244038Lang 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.
- Results publication: PubMed 16959427Lang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elvira V Lang, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-hypnotic Relaxation and Empathic Attention in people with Breast Cancer and Anxiety, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Ratings at Specified Time Point During the Procedure (time frame: 0 min). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122369, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2013.