Trial Outcomes & Findings for Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy (NCT NCT00122369)

NCT ID: NCT00122369

Last Updated: 2013-02-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 240 participants
• Primary outcome timeframe: 0 min
• Results posted on: 2013-02-28

Participant Flow

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.

Participant milestones

Measure	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.	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)	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.
Overall Study STARTED	76	82	78
Overall Study COMPLETED	76	82	78
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=82 Participants 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)	Self-Hypnotic Relaxation n=78 Participants 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.	Total n=236 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants	74 Participants n=7 Participants	73 Participants n=5 Participants	216 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Age Continuous	49.2 years STANDARD_DEVIATION 13.4 • n=5 Participants	48.0 years STANDARD_DEVIATION 13.22 • n=7 Participants	47.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	48.3 years STANDARD_DEVIATION 13.4 • n=4 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	82 Participants n=7 Participants	78 Participants n=5 Participants	236 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	76 participants n=5 Participants	82 participants n=7 Participants	78 participants n=5 Participants	236 participants n=4 Participants

PRIMARY outcome

Timeframe: 0 min

Population: Intention to Treat; patients on procedure table

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.

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=82 Participants 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)	Self-Hypnotic Relaxation n=78 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4.5 units on a scale Interval 2.0 to 6.0	5 units on a scale Interval 3.0 to 7.0	5 units on a scale Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: 10 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=81 Participants 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)	Self-Hypnotic Relaxation n=77 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 2.0 to 6.0	4 units on a scale Interval 2.0 to 7.0	4 units on a scale Interval 2.0 to 6.0

PRIMARY outcome

Timeframe: 20 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=81 Participants 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)	Self-Hypnotic Relaxation n=75 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 2.0 to 6.0	4 units on a scale Interval 2.0 to 7.0	3 units on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: 30 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=70 Participants 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.	Empathic Attention n=72 Participants 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)	Self-Hypnotic Relaxation n=66 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 2.0 to 6.5	4.5 units on a scale Interval 2.0 to 6.0	4 units on a scale Interval 2.0 to 6.0

PRIMARY outcome

Timeframe: 40 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=59 Participants 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.	Empathic Attention n=57 Participants 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)	Self-Hypnotic Relaxation n=52 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 3.0 to 7.0	5 units on a scale Interval 3.0 to 6.0	4 units on a scale Interval 1.25 to 6.0

PRIMARY outcome

Timeframe: 50 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=42 Participants 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.	Empathic Attention n=45 Participants 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)	Self-Hypnotic Relaxation n=39 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	6 units on a scale Interval 2.75 to 7.0	4 units on a scale Interval 2.0 to 6.0	3 units on a scale Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: 60 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=32 Participants 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.	Empathic Attention n=31 Participants 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)	Self-Hypnotic Relaxation n=26 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 2.25 to 8.0	4 units on a scale Interval 2.0 to 6.0	2.5 units on a scale Interval 0.0 to 5.25

PRIMARY outcome

Timeframe: 70 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=23 Participants 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.	Empathic Attention n=23 Participants 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)	Self-Hypnotic Relaxation n=20 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 3.0 to 8.0	3 units on a scale Interval 2.0 to 6.0	2.5 units on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 80 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=15 Participants 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.	Empathic Attention n=12 Participants 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)	Self-Hypnotic Relaxation n=8 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 2.0 to 8.0	4 units on a scale Interval 2.0 to 6.0	3 units on a scale Interval 0.0 to 4.75

PRIMARY outcome

Timeframe: 90 min

Population: 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)

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

Outcome measures

Measure	Standard of Care n=8 Participants 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.	Empathic Attention n=7 Participants 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)	Self-Hypnotic Relaxation n=5 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 0.5 to 8.75	7 units on a scale Interval 1.0 to 8.0	0.5 units on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 100 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=7 Participants 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.	Empathic Attention n=5 Participants 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)	Self-Hypnotic Relaxation n=5 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 0.0 to 9.0	3 units on a scale Interval 0.0 to 5.5	2 units on a scale Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 110 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=4 Participants 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.	Empathic Attention n=2 Participants 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)	Self-Hypnotic Relaxation n=1 Participants 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.
Anxiety Ratings at Specified Time Point During the Procedure	4.5 units on a scale Interval 0.5 to 8.5	2 units on a scale Interval 0.0 to 3.0	5 units on a scale Interval 5.0 to 5.0

PRIMARY outcome

Timeframe: 0-110 min

Population: Intent to Treat; patients undergoing breast biopsy

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.

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=82 Participants 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)	Self-Hypnotic Relaxation n=78 Participants 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.
Time Trends of Anxiety Experience	0.18 logit slopes	-0.04 logit slopes	-0.27 logit slopes

PRIMARY outcome

Timeframe: 0 min

Population: 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).

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

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=82 Participants 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)	Self-Hypnotic Relaxation n=78 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	0 units on a scale Interval 0.0 to 1.75	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: 10 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=81 Participants 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)	Self-Hypnotic Relaxation n=77 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 1.0	0 units on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 20 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=81 Participants 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)	Self-Hypnotic Relaxation n=75 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	1 units on a scale Interval 0.0 to 4.0	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 30 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=70 Participants 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.	Empathic Attention n=72 Participants 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)	Self-Hypnotic Relaxation n=65 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	2 units on a scale Interval 0.0 to 4.0	0 units on a scale Interval 0.0 to 3.0	0 units on a scale Interval 0.0 to 2.0

PRIMARY outcome

Timeframe: 40 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=59 Participants 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.	Empathic Attention n=57 Participants 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)	Self-Hypnotic Relaxation n=52 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	2 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 4.0	0 units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 50 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=41 Participants 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.	Empathic Attention n=45 Participants 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)	Self-Hypnotic Relaxation n=39 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 0.0 to 6.0	2 units on a scale Interval 0.0 to 4.5	1 units on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: 60 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=32 Participants 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.	Empathic Attention n=31 Participants 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)	Self-Hypnotic Relaxation n=26 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	2.5 units on a scale Interval 0.0 to 4.0	2 units on a scale Interval 0.0 to 5.0	1 units on a scale Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: 70 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=23 Participants 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.	Empathic Attention n=23 Participants 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)	Self-Hypnotic Relaxation n=20 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	4 units on a scale Interval 2.0 to 6.0	2 units on a scale Interval 0.0 to 4.0	2 units on a scale Interval 0.0 to 4.5

PRIMARY outcome

Timeframe: 80 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=15 Participants 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.	Empathic Attention n=12 Participants 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)	Self-Hypnotic Relaxation n=8 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 2.0 to 7.0	3.5 units on a scale Interval 1.25 to 4.75	2.5 units on a scale Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 90 min

Population: 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).

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

Outcome measures

Measure	Standard of Care n=8 Participants 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.	Empathic Attention n=7 Participants 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)	Self-Hypnotic Relaxation n=5 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	5 units on a scale Interval 5.0 to 8.0	2 units on a scale Interval 1.0 to 5.0	1.5 units on a scale Interval 0.0 to 7.5

PRIMARY outcome

Timeframe: 100 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=7 Participants 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.	Empathic Attention n=5 Participants 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)	Self-Hypnotic Relaxation n=5 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	9 units on a scale Interval 7.0 to 9.0	2 units on a scale Interval 1.0 to 4.5	2 units on a scale Interval 0.5 to 5.5

PRIMARY outcome

Timeframe: 110 min

Population: Patients remaining on procedure table

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

Outcome measures

Measure	Standard of Care n=4 Participants 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.	Empathic Attention n=2 Participants 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)	Self-Hypnotic Relaxation n=1 Participants 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.
Pain Ratings at Specified Time Point During the Procedure	8.5 units on a scale Interval 8.0 to 9.75	3 units on a scale Interval 3.0 to 3.0	10 units on a scale Interval 10.0 to 10.0

PRIMARY outcome

Timeframe: 0-110 min

Population: Intent to Treat; patients undergoing breast biopsy

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.

Outcome measures

Measure	Standard of Care n=76 Participants 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.	Empathic Attention n=82 Participants 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)	Self-Hypnotic Relaxation n=78 Participants 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.
Time Trends of Pain Experience	0.53 logit slopes	0.37 logit slopes	0.34 logit slopes

SECONDARY outcome

Timeframe: Patients were followed for the 5 days following their breast biopsy

Population: 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.

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.

Outcome measures

Measure	Standard of Care n=37 Participants 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.	Empathic Attention n=16 Participants 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)	Self-Hypnotic Relaxation n=73 Participants 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.
Salivary Cortisol Secretion	-0.154 ln (microgram/dL)/hr Interval -0.197 to -0.111	-0.110 ln (microgram/dL)/hr Interval -0.147 to -0.073	-0.092 ln (microgram/dL)/hr Interval -0.113 to -0.072

SECONDARY outcome

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

Population: These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.

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

Outcome measures

Measure	Standard of Care n=7 Participants 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.	Empathic Attention n=4 Participants 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)	Self-Hypnotic Relaxation n=8 Participants 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.
Impact of Event Scale (IES-15)	25 Scores on a Scale Standard Deviation 10.7	27 Scores on a Scale Standard Deviation 13.7	24 Scores on a Scale Standard Deviation 15

Adverse Events

Standard of Care

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Empathic Attention

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Self-Hypnotic Relaxation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standard of Care n=76 participants at risk 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.	Empathic Attention n=82 participants at risk 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)	Self-Hypnotic Relaxation n=78 participants at risk 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.
Surgical and medical procedures Hematoma	6.6% 5/76 • Number of events 5 • 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	11.0% 9/82 • Number of events 9 • 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	3.8% 3/78 • Number of events 3 • 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
Surgical and medical procedures Vasovagal episode	1.3% 1/76 • Number of events 1 • 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	2.4% 2/82 • Number of events 2 • 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	0.00% 0/78 • 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
Surgical and medical procedures Vomiting	1.3% 1/76 • Number of events 1 • 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	0.00% 0/82 • 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	0.00% 0/78 • 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

Additional Information

Elvira V. Lang, MD

Beth Israel Deaconess Medical Center (at time of study); now Hypnalgesics, LLC

Phone: 978 404 9724

Email: elang@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place