Hypnosis patients had less pain, anxiety, and medication use than patients receiving standard care treatment. This is consistent with previous trials of invasive medical procedures (1
), although the procedures in this study were more invasive by induction of tissue death, and patients were aware of overall greater treatment risks. Surprisingly, findings in the empathy group differed markedly from prior studies (1
). A strikingly high adverse event rate (31/65; 48%) significantly exceeded that under hypnosis (8/66; 12%) and standard care (18/70; 26%) and ultimately prompted halting this trial. We were able to treat all the occurrences successfully, and small patient numbers in consideration of the low delayed major complication rates do not permit a statistically meaningful conclusion about the long-term impact. One should, however, not underestimate the stress such procedural adverse events place on team and patients. At the time of their occurrence it is not clear whether these events are reversible or portend further untoward sequelae. We therefore chose to err on the side of patients’ safety.
Hypnosis has been shown to reduce cardiac sympathetic activity and myocardial ischemia during percutaneous transluminal angioplasty (24
) and to improve the heart rate variability profile (25
), a quantitative measure of changes in intervals of heart beats associated with autonomic function and predictive of cardiovascular risk (27
). Trance can occur spontaneously without formal induction, particularly under conditions of stress (28
). Patients in the hypnosis group - and possibly some in the standard group, who might have experienced spontaneous hypnosis - may have benefited from such improved autonomic function and thus may have escaped excessive adverse events. Conversely, patients in the empathic attention condition may have been less able to engage their internal coping skills due to the external focus of attention i.e., the sympathizing personnel, thus resulting in poorer autonomic function and higher rates of adverse events. The higher medication use in the empathy group, in contrast to a prior vascular/renal intervention trial (1
), may be partly explained by the provision in the protocol that patients who become hypertensive or tachycardic could receive nurse-administered medication without patient request. It is also possible that the higher medication is an expression of the greater reliance on external provision of comfort. That there was no significant difference in room time among groups is likely due to the rate-limiting slowness by which embolization agents can be infused and radiofrequency-necrosis can be induced.
Percutaneous tumor treatments are prone to induce patient distress. Perceiving others in distress produces an affective response, which is oriented to decrease distress to the observer as well as to the suffering person, and elicits a behavioural response, which may be targeted towards providing comfort and reassurance or withdrawl (29
). This affective response to the perception of others’ pain can be documented on functional MRI and is the higher in intensity the higher the observer scores on empathy scales (30
). Higher scores on empathy scales however do not necessarily translate in appropriate clinical behaviour. A study in the postoperative acute care setting reports that nurses who scored higher on such empathy scales, but did not have advanced education in patient interactions, did not provide better pain management for their patients (31
). Well-meant sympathizing comments by caregivers can even produce nocebo effects if wording is not chosen carefully (32
). In a setting where physicians and nurses are aware of the procedural risks and may have witnessed serious complications and even death on the procedure table, one should not underestimate the fears these individuals bring with them into the procedure room. During review of the videotapes we noted often nervous laughter and attempts at lightening the atmosphere with gentle jokes when patients were first brought into the room. One may speculate that seeing the expression of a patient becoming more relaxed while entering trance may potentially also calm the procedure team.
In the standard care condition, nurses left patients mainly on their own once the procedure started, checked on their well-being from time to time, when called by the patient, or at critical parts of the procedure. In the empathy condition, nurses engaged to a greater extent with the patient and the empathic care provider. There were more frequent interactions of a conversational nature. These conversations followed patterns of social interactions; e.g. when patients mentioned topics such as travel, careers, or encounters with the health care system, nurses expressed understanding and sympathy by contributing their own experiences. Rather than being a pleasant distraction, such discussions may have been experienced as disinterest on the part of the caregiver in the patient’s distress. It is also possible that the responsive stance activity in the empathy condition served to further focus subjects’ attention on their reported distress without giving them a means of controlling that distress, thereby compounding it. Conversely, in the hypnosis group, topics the patient mentioned were used by the researchers to structure desirable imagery, and, if they hinted at distressing emotional content, were further explored and addressed according to the provisions of the script and training manual. The focus was on helping patients help themselves. Thus the researcher displaying empathic attention skills did not remain an external focus of coping as in the empathy only group, but enabled patients to mobilize their own internal resources and engage in self-hypnosis.
There are various interpretations of empathy (5
). In a review, Irving et al showed how the construct of empathy is surrounded by “ambiguity and conceptual confusion” and how this complicates its study and application in the health setting (7
). A patient’s experience may be far from that of the caregiver, and emotional understanding requires careful listening on the part of the observer so that the observer’s response can match the patient’s affective state (34
). While nurses in our study expressed great sympathy the results seem to support that trying to be “nice” does not suffice. Ideally, a positive feedback is set up from which the observer can identify the patient’s feelings, concerns or quandaries and reflect that back in an appropriate empathic response. This however requires considerable interpersonal skill training.
The study has limitations. We halted the trial because of a high adverse event rate in the empathy group. Analyses of the original planned primary outcomes (pain, anxiety, drug use, and adverse events) could not be performed at the power level planned and statistical analyses were adapted to the lower patient numbers. Total blinding of the operators was not achieved since the voice level in the procedure room and whole atmosphere typically calmed considerably after induction of hypnosis. Pain and anxiety data may have been biased since the individuals structuring empathy and hypnosis obtained them, but these demand characteristics should then have affected patients’ ratings in both conditions similarly. Moreover, the main finding of the study, the difference in adverse event rates, was based on objective hemodynamic and respiratory data obtained from automated machines.
This study was able to show beneficial effects of analgesic and anxiolytic hypnotic techniques employing hypnosis in conjunction with empathic attention during invasive tumor treatment and the adverse effects empathy alone without appropriate behavioral responses can elicit. Other treatments with a lower probability of hemodynamic and cardiorespiratory disturbances would have required much larger patient numbers to provide sufficient power for a meaningful comparison among groups. For example, in a trial with 236 women undergoing large core breast biopsy with local anesthesia only, there were one vasovagal episode in the standard care group, two in the empathy group, and none in the hypnosis group (4
). Less invasive procedures have lower odds of adverse events overall, but they are performed more commonly, and in the aggregate, potential adverse effect of an incomplete empathic approach can affect large numbers of patients and caregivers. It is important for caregivers to be aware of the effect of their behavior on patient outcomes not only in psychosocial but also hemodynamic terms. This will require considerable efforts in promoting awareness and training. It would appear that non-specific support without providing means of managing acute pain and anxiety may do more harm than good.