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| ID | Type | Description | Link |
|---|---|---|---|
| 2001P-001681 |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-hypnotic Relaxation | Behavioral | A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Patients are excluded if :
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| Name | Affiliation | Role |
|---|---|---|
| Elvira V Lang, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19244038 | Result | 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. | |
| 16959427 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. |
| FG001 | Empathic Attention | The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) |
| FG002 | Self-Hypnotic Relaxation | In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. |
| BG001 | Empathic Attention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to Treat; patients on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 0 min |
|
Patients were followed for up to one week after their biopsy
Adverse event reporting was done using the Reporting Standard of the Society of Interventional Radiology
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | SIR Standard | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira V. Lang, MD | Beth Israel Deaconess Medical Center (at time of study); now Hypnalgesics, LLC | 978 404 9724 | elang@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Empathic Attention | Behavioral | A research assistant displayed defined behaviors of empathic attention. |
|
|
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 |
| 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 | Patients were followed for up to 3 weeks after their biopsy until the time of their surgery |
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) |
| BG002 | Self-Hypnotic Relaxation | In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Empathic Attention |
The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) |
| OG002 | Self-Hypnotic Relaxation | In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. |
|
|
| 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. | Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the "known malignant" group, 37 in the "known benign" group, and 73 in the "uncertain group" totaling 126 patients. | Posted | Mean | 95% Confidence Interval | ln (microgram/dL)/hr | Patients were followed for the 5 days following their breast biopsy |
|
|
|
|
| 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 | These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy. | Posted | Mean | Standard Deviation | Scores on a Scale | Patients were followed for up to 3 weeks after their biopsy until the time of their surgery |
|
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 10 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 20 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 30 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 40 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 50 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 60 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 70 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 80 min |
|
|
|
| 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 | Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point) | Posted | Median | Inter-Quartile Range | units on a scale | 90 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 100 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 110 min |
|
|
|
| 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. | Intent to Treat; patients undergoing breast biopsy | Posted | Number | logit slopes | 0-110 min |
|
|
|
|
| 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 | Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point). | Posted | Median | Inter-Quartile Range | units on a scale | 0 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 10 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 20 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 30 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 40 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 50 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 60 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 70 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 80 min |
|
|
|
| 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 | Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point). | Posted | Median | Inter-Quartile Range | units on a scale | 90 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 100 min |
|
|
|
| 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 | Patients remaining on procedure table | Posted | Median | Inter-Quartile Range | units on a scale | 110 min |
|
|
|
| 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. | Intent to Treat; patients undergoing breast biopsy | Posted | Number | logit slopes | 0-110 min |
|
|
|
|
| 0 |
| 76 |
| 7 |
| 76 |
| EG001 | Empathic Attention | The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) | 0 | 82 | 11 | 82 |
| EG002 | Self-Hypnotic Relaxation | In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. | 0 | 78 | 3 | 78 |
| Vasovagal episode | Surgical and medical procedures | SIR Standard | Systematic Assessment |
|
| Vomiting | Surgical and medical procedures | SIR Standard | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| t-test, 2 sided | 0.421 | Bonferoni correction was made so that results with p<0.0167 are considered significant. | 95 | No | Superiority or Other |
| t-test, 2 sided | 0.138 | Bonferoni correction was made so that results with p<0.0167 are considered significant. | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Ordinal regression | <0.001 | 95 | No | Superiority or Other |
| Proportional odds model | <0.01 | 95 | No | Superiority or Other |
| Proportional odds model | <0.001 | 95 | No | Superiority or Other |
| Proportional odds model | <0.01 | 95 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Ordinal regression | <0.001 | 95 | No | Superiority or Other |
| Proportional odds model | 0.024 | 95 | No | Superiority or Other |
| Proportional odds model | 0.018 | 95 | No | Superiority or Other |
| Proportional odds model | 0.73 | 95 | No | Superiority or Other |