A Phase 2 interventional study of Self-hypnotic Relaxation and Empathic Attention in Breast Cancer, Anxiety and Pain, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-28.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2 and Interventional
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.
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:
The researchers hypothesize that:
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.
Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are excluded if :
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 Relaxation · Behavioral: Empathic Attention
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.
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
A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.
Also known as: Comfort Talk®
A research assistant displayed defined behaviors of empathic attention.
Also known as: Empathy, Advanced Rapport Skills
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 0-110 min
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.
Time frame: 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
Time frame: Patients were followed for up to 3 weeks after their biopsy until the time of their surgery
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.
| Milestone | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Started | 76 | 82 | 78 |
| Completed | 76 | 82 | 78 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4.5 (2 to 6) | 5 (3 to 7) | 5 (3 to 6) |
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.
| ln (microgram/dL)/hr | Known Benign Disease | Known Malignant Disease | Uncertain Diagnosis |
|---|---|---|---|
| Salivary Cortisol Secretion | -0.154 (-0.197 to -0.111) | -0.110 (-0.147 to -0.073) | -0.092 (-0.113 to -0.072) |
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
| Scores on a Scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Impact of Event Scale (IES-15) | 25 ± 10.7 | 27 ± 13.7 | 24 ± 15 |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4 (2 to 6) | 4 (2 to 7) | 4 (2 to 6) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4 (2 to 6) | 4 (2 to 7) | 3 (2 to 5) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4 (2 to 6.5) | 4.5 (2 to 6) | 4 (2 to 6) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 5 (3 to 7) | 5 (3 to 6) | 4 (1.25 to 6) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 6 (2.75 to 7) | 4 (2 to 6) | 3 (1 to 5) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 5 (2.25 to 8) | 4 (2 to 6) | 2.5 (0 to 5.25) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 5 (3 to 8) | 3 (2 to 6) | 2.5 (0 to 4) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 5 (2 to 8) | 4 (2 to 6) | 3 (0 to 4.75) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 5 (0.5 to 8.75) | 7 (1 to 8) | 0.5 (0 to 4) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4 (0 to 9) | 3 (0 to 5.5) | 2 (0 to 5) |
Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Anxiety Ratings at Specified Time Point During the Procedure | 4.5 (0.5 to 8.5) | 2 (0 to 3) | 5 (5 to 5) |
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.
| logit slopes | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Time Trends of Anxiety Experience | 0.18 | -0.04 | -0.27 |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 0 (0 to 1.75) | 0 (0 to 0) | 0 (0 to 1) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 0 (0 to 2) | 0 (0 to 1) | 0 (0 to 2) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 1 (0 to 4) | 0 (0 to 2) | 0 (0 to 2) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 2 (0 to 4) | 0 (0 to 3) | 0 (0 to 2) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 2 (0 to 5) | 2 (0 to 4) | 0 (0 to 3) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 4 (0 to 6) | 2 (0 to 4.5) | 1 (0 to 3) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 2.5 (0 to 4) | 2 (0 to 5) | 1 (0 to 6) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 4 (2 to 6) | 2 (0 to 4) | 2 (0 to 4.5) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 5 (2 to 7) | 3.5 (1.25 to 4.75) | 2.5 (0 to 7) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 5 (5 to 8) | 2 (1 to 5) | 1.5 (0 to 7.5) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 9 (7 to 9) | 2 (1 to 4.5) | 2 (0.5 to 5.5) |
Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
| units on a scale | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Pain Ratings at Specified Time Point During the Procedure | 8.5 (8 to 9.75) | 3 (3 to 3) | 10 (10 to 10) |
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.
| logit slopes | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| Time Trends of Pain Experience | 0.53 | 0.37 | 0.34 |
Collected over Patients were followed for up to one week after their biopsy. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | — | 0/76 (0%) | 7/76 (9.2%) |
| Empathic Attention | — | 0/82 (0%) | 11/82 (13.4%) |
| Self-Hypnotic Relaxation | — | 0/78 (0%) | 3/78 (3.8%) |
| Event | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation |
|---|---|---|---|
| HematomaSurgical and medical procedures | 5/76 | 9/82 | 3/78 |
| Vasovagal episodeSurgical and medical procedures | 1/76 | 2/82 | 0/78 |
| VomitingSurgical and medical procedures | 1/76 | 0/82 | 0/78 |
| Age, Categorical(Participants) | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 69 | 74 | 73 | 216 |
| >=65 years | 7 | 8 | 5 | 20 |
| Age Continuous(years) | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation | Total |
|---|---|---|---|---|
| Mean | 49.2 ± 13.4 | 48.0 ± 13.22 | 47.8 ± 13.7 | 48.3 ± 13.4 |
| Sex: Female, Male(Participants) | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation | Total |
|---|---|---|---|---|
| Female | 76 | 82 | 78 | 236 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard of Care | Empathic Attention | Self-Hypnotic Relaxation | Total |
|---|---|---|---|---|
| United States | 76 | 82 | 78 | 236 |
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Beth Israel Deaconess Medical Center