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Archives of cardiovascular diseases
Volume 109, n° 3
pages 171-177 (mars 2016)
Doi : 10.1016/j.acvd.2015.09.008
Received : 26 January 2015 ;  accepted : 15 September 2015
HypnosIS to faciLitate trans-Esophageal echocardiograPhy Tolerance: The I-SLEPT study
Utilisation de l’hypnose pour faciliter l’échocardiographie trans-œsophagienne : l’étude I-SLEPT
 

Isabelle Corman a, 1, Yasmina Bouchema a, 1, Béatrice Miquel b, Hélène Rousseau b, Dominique Bouvier a, Nicolas Voilmy a, Florence Beauvais a, Alain Cohen-Solal a, c, Eric Vicaut b, Damien Logeart a, c, François Tournoux a, c, d,
a Service de Cardiologie, Hôpital Lariboisière, Assistance publique–Hôpitaux de Paris, Université Paris 7, 75010 Paris, France 
b Unité de Recherche Clinique, Hôpital Lariboisière, Assistance publique–Hôpitaux de Paris, Université Paris 7, 75010 Paris, France 
c Unité Inserm U942, 75010 Paris, France 
d Division de Cardiologie, Département de Médecine, Centre Hospitalier de l’Université de Montréal (CHUM), Montréal, Québec, Canada 

Corresponding author at: Division de Cardiologie, Département de Médecine, Centre Hospitalier de l’Université de Montréal (CHUM), 3840, rue Saint Urbain, Montréal, Québec H2W 1T8, Canada.
Summary
Background

Trans-oesophageal echocardiography (TOE) is one of the major diagnostic tests in cardiovascular medicine, but the procedure is associated with some discomfort for the patient.

Aim

To determine the additive value of hypnosis as a means of improving patient comfort during TOE.

Methods

We randomly assigned 98 patients with non-emergency indications for TOE to a 30-minute hypnosis session combined with topical oropharyngeal anaesthesia (HYP group) or topical oropharyngeal anaesthesia only (CTRL group) before the procedure. The primary efficacy endpoint was the level of patient discomfort assessed using a visual analogue scale (VAS).

Results

The VAS score was significantly reduced in the HYP group compared with the CTRL group (6 [5; 8] vs. 7 [5; 9]; P =0.046). No statistically significant differences were observed in terms of procedure failure (HYP group 2.2% vs. CTRL group 3.9%; P =1.00) and procedure length (HYP group 7 [5; 11] minutes vs. CTRL group 8 [7; 11] minutes; P =0.29). However, the patients’ subjective estimations of the length of the procedure were significantly shorter in the HYP group than in the CTRL group (8 [5; 10] vs. 10 [10; 20] minutes; P <0.0001). There were no major adverse events in either group. The reported minor events rate was lower in the HYP group (36% vs. 57%; P =0.04).

Conclusion

Hypnosis is an efficient alternative or complementary method for improving patient comfort during TOE.

The full text of this article is available in PDF format.
Résumé
Contexte

L’échocardiographie trans-œsophagienne (ETO) est l’un des principaux tests diagnostiques en médecine cardiovasculaire, mais cette procédure s’accompagne d’un certain inconfort pour le patient.

Objectif

Le but de cette étude était de déterminer quel pourrait être l’apport de l’hypnose pour améliorer le confort du patient pendant une ETO.

Méthodes

Nous avons randomisé 98 patients avec des indications non urgentes d’ETO : préparation pré-examen comprenant une session de 30minutes d’hypnose associée à une anesthésie topique oropharyngée (groupe HYP) versus une préparation avec anesthésie topique oropharyngée seule (groupe CTRL). Le critère d’efficacité primaire était le niveau d’inconfort du patient évalué par une échelle visuelle analogique (EVA).

Résultats

Le niveau de l’EVA a été significativement réduit dans le groupe HYP (EVA de 6 [5 ; 8] contre 7 [5 ; 9] dans le groupe CTRL ; p =0,046). Aucune différence statistiquement significative n’a été observée entre les deux groupes en termes d’échec de procédure (2,2 % dans le groupe HYP contre 3,9 % ; p =1,00) ou de longueur de la procédure (7 [5 ; 11] dans le groupe HYP contre 8 [7 ; 11] minutes ; p =0,29). Cependant l’estimation subjective par le patient de la durée de la procédure était significativement plus courte dans le groupe HYP (8 [5 ; 10] vs 10 [10 ; 20] minutes ; p <0,0001). Il n’y a eu aucun événement indésirable majeur dans chacun des deux groupes. Moins d’événements mineurs ont été rapportés dans le groupe de HYP (36 % vs 57 % ; p =0,04).

Conclusion

L’hypnose est une méthode complémentaire efficace pour améliorer le confort du patient lors d’une ETO.

The full text of this article is available in PDF format.

Keywords : Topical oropharyngeal anesthesia, Trans-oesophageal echocardiography, Hypnosis

Mots clés : Anesthésie topique oropharyngée, Échocardiographie trans-œsophagienne, Hypnose

Abbreviations : AP–HP, IV, TOE, VAS


Background

Trans-oesophageal echocardiography (TOE) is one of the major diagnostic tests in cardiovascular medicine. However, it can be the source of severe discomfort, leading to probe insertion failure and cancellation (1.9% of cases) or premature termination of the study before adequate data are obtained (0.6% of cases [1]). Moderate or complete general anaesthesia cannot always be performed, as it may adversely affect the diagnostic value of the procedure and/or patient safety [2]. Finally, a history of unsuccessful probe insertion may dramatically compromise the success of a new attempt.

Hypnosis is widely used in pain management, and has been shown to be a valuable alternative or complement to traditional anaesthesia, with the advantage of allowing a reduction in the dose of anaesthesia [3, 4]. In a hypnotic state, a patient's sensitivity to a stimulus and his or her emotional interpretation of this stimulus are dissociated [5], and subjective feelings of discomfort can be dramatically reduced; the painful stimulus then becomes acceptable to the patient.

The main goal of this study was to determine the additive value of hypnosis as a means of improving patient comfort during TOE.

Methods
Study population

The study included patients with non-emergency indications for TOE. Patients were excluded if they were not registered in the French social security system, were unable to understand French, had severe neuropsychiatric disease, were not available for long-term follow-up, were aged<18years or could not provide informed consent. The study was performed at Hôpital Lariboisière, Assistance publique–Hôpitaux de Paris (AP–HP), France.

Study enrolment and randomization

Included patients were randomized into two arms: group 1 (the HYP group) received a hypnosis session within the 24hours before the procedure plus topical oropharyngeal anaesthesia; group 2 (the CTRL group) received topical oropharyngeal anaesthesia only. Computer-based randomization was done by the statistical department of the clinical trial unit, and the treatment arm was communicated to the psychologist only.

Once randomized, each patient was left alone with the psychologist, who provided information about the procedure, followed immediately or not by 30minutes of hypnosis. The hypnosis session started with general relaxation and suggestions of peaceful and pleasant images; then the psychologist suggested specific symptoms linked to the TOE procedure, such as pain, nausea, acute dyspnoea or a feeling of suffocation, and explained carefully how to breathe quietly with a probe within the oesophagus.

Once the meeting between the patient and the psychologist was concluded, the TOE procedure was performed within 24hours by a senior physician blinded to the results of the randomization.

Study endpoints

The primary efficacy endpoint was the level of patient discomfort assessed using a visual analogue scale (VAS). The secondary efficacy endpoints were rate of procedure failure, length and quality of the procedure, and rate of complications; these secondary endpoints were assessed by a blinded operator who had not performed the TOE. All endpoints were assessed immediately after the procedure, and by telephone interview 24hours, 7days, 1month and 3months later. As a visual analogue scale cannot be used during a telephone interview, the patient was asked to grade his or her memory of discomfort from 0 to 10.

Study supervision

This randomized, single-blind, single-centre study was designed by the principal investigator (F.T.) and the methodologist (E.V.). The study protocol is available at ClinicalTrials.gov (NCT01095705). The trial was sponsored by the Direction de la Recherche Clinique at AP–HP, and was funded by the French Federation of Cardiology, the French Society of Cardiology and the Direction de la Recherche Clinique at AP–HP. These three institutions had no involvement in the design of the study, site selection, data collection, analysis or writing of the manuscript. The protocol was approved by the National Ethical Review Boards (ID RCB 2008-A01156-51 and AFSSAPS B91444-80) in France. Data were held at the Unité de Recherche Clinique (Lariboisière Hospital, University Paris 7), which independently performed all statistical analyses. The statistician (H.R.) vouches for the integrity and completeness of the data, and for the accuracy of the data analysis.

Statistical analysis

A sample size of 85 patients per group was initially calculated in order to have a 90% power to detect a difference equal to 1.5 on the VAS (primary endpoint), assuming a standard deviation of the variable equal to 3 (estimated from a pilot study) and a two-sided 5% significance level. Because of a lower than anticipated enrolment rate, the study was stopped by the sponsor before the calculated sample size had been reached.

Results are summarised as means±standard deviations for Gaussian variables or medians and quartiles for non-Gaussian continuous variables. Categorical variables are presented as numbers and frequencies. The two groups were compared using Student's t -test or the Mann-Whitney test for continuous variables. The Chi2 test or Fisher's exact probability test (when conditions of validity of the Chi2 test were not fulfilled) were used for categorical variables. All analyses were performed based on the intent-to-treat randomization, using SAS software, version 9.2 (SAS Institute Inc., Cary, NC, USA).

Results

A total of 101 patients were included. Three patients were excluded secondarily because of last-minute procedure cancellations. Forty-seven patients were randomized to the HYP group (mean age 60±15years, 34% women) and 51 to the CTRL group (mean age 55±14years, 43% women) (Figure 1). Overall, 40% of the examinations were performed because of a recent neurological event, 32% as a diagnostic test for cardiovascular disease, and 28% to rule out a left atrium thrombus before a cardiac procedure.



Figure 1


Figure 1. 

Study flow chart. CTRL: control; HYP: hypnosis; M1: month 1.

Zoom

There was no significant difference between the two groups (see Table 1) in terms of sex, age, TOE indication, history of TOE (only 14 patients in total), the number of TOEs undergone previously per patient, how these TOEs were performed (local anaesthesia versus intravenous sedation or global anaesthesia) and anticipated discomfort before the procedure (VAS score of 5 [5; 8] in the HYP group vs. 6 [5; 8] in the CTRL group; P =0.50).

Day of the procedure

Hypnosis significantly reduced patient discomfort (VAS score of 6 [5; 8] in the HYP group vs. 7 [5; 9] in the CTRL group; P =0.046; Figure 2A). Hypnosis was mostly effective during long procedures (procedure durationmedian duration: VAS score of 6 [3; 7] in the HYP group vs. 7 [5; 9] in the CTRL group; P =0.02), while no significant effect was shown during short procedures (procedure duration<median duration: VAS score of 6 [5; 8] in the HYP group vs. 7 [5; 9] in the CTRL group; P =0.29).



Figure 2


Figure 2. 

Comparison between CTRL and HYP groups for (A) anticipated discomfort before the procedure (VAS); (B) relative procedure length; and (C) rate of minor complications. CTRL: control; HYP: hypnosis; VAS: visual analogue scale.

Zoom

TOE could not be performed in 3.9% of the CTRL group compared with 2.2% of the HYP group (P =1.00). Independent of the effect of hypnosis, age (but not sex or TOE indication) was a significant predictor (P =0.0002) of patient discomfort (age<54years: VAS score of 8 [7; 10]; 54yearsage<64years: VAS score of 6 [4: 7]; age64years: VAS score of 5 [5: 7]). The actual procedure length was 7 [5; 11] minutes in the HYP group vs. 8 [6; 11] minutes in the CTRL group (P =0.29). However, the patients’ subjective estimations of the length of the procedure were significantly shorter in the HYP group (8 [5; 10] vs. 10 [10; 20] minutes in the CTRL group; P <0.0001) and more closely reflected the true procedure time whereas in the CTRL group the perceived time was significantly higher (Figure 2B). In addition to the effect of hypnosis, male sex and an indication to rule out left atrial thrombus were significantly associated with a shorter procedure (10 [5; 15] vs. 10 [10; 20] minutes and 8 [5; 10] vs. 10 [8; 15] minutes, respectively; P =0.04 for both variables), while no association was found for the age of the patient. For the physician performing the TOE, procedure quality was similar in both groups (P =0.26), but there was a trend in favour of less agitated behaviour in the HYP group (P =0.08; Table 2).

Follow-up

Follow-up data up to 3months were available for 96% of the HYP group and 92% of the CTRL group (P =0.68). At day 1, there were no major adverse events in either group. There was a significant difference in terms of minor events between the HYP and CTRL groups (P =0.04; Figure 2C, Table 3). Over time, the patient's memory of the discomfort during TOE was significantly different at day 1 and 1week between the HYP and CTRL groups (P =0.04 and 0.03, respectively), but not at 1month and 3months (P =0.06 and 0.10, respectively).

Discussion

In this study, a brief hypnosis intervention before TOE significantly reduced patient discomfort, with no adverse events and without compromising the performance of the procedure. In fact, there were fewer minor adverse events in HYP group than in the CTRL group. These findings are similar to those published in a smaller study, where hypnosis was also effective in reducing the level of discomfort during the procedure [6].

Hypnosis is an advanced stage of mental focus, with a limited perception of the surrounding environment and an increased capacity to follow commands [4]. When using hypnosis, one person (the subject) is guided by another (the hypnotist) to respond to suggestions for changes in subjective experience – alterations in perception, sensation, emotion, thought or behaviour [5]. It is similar to being “absorbed” by a compelling book or movie, with the feeling of being part of a different environment, and partially losing the sense of the actual surrounding environment. The hypnotist guides patients through peaceful and relaxing images to help them become less sensitive to averse stimuli and more relaxed. The patient will be more open to therapeutic suggestions [7], and the response to a painful feeling will be reduced [8, 9]. Hypnosis is effective for controlling various symptoms (pain, nausea, vomiting, fatigue) [10, 11, 12], and its use is well-established in oncology [13, 14, 15] and for various surgical procedures (breast surgery [16], plastic surgery [17], coronary artery bypass [18, 19] and ophthalmic surgery [20]). Hypnosis can reduce postoperative symptoms, the need for analgesics and the length of hospital stay [21]. Hypnosis has also been used to manage pain and anxiety in medical procedures, including invasive radiological procedures [22] and colonoscopy [23, 24].

As TOE is a semi-invasive diagnostic procedure, with potential adverse effects and discomfort for the patient, local anaesthesia with lidocaine is usually performed. The use of intravenous (IV) drugs, such as midazolam, is a well-established complementary technique to improve patient tolerance [25, 26]. However these drugs can induce cardiovascular depression, hypoxia, apnoea, unconsciousness and, rarely, death, even at a usual dosage [2, 27, 28]. Furthermore, these drugs may limit the patient's ability to follow commands during the procedure. This reduced patient involvement can compromise the diagnostic performance of TOE in specific situations, such as an evaluation for patent foramen ovale, when a Valsalva manoeuvre is required. Hypnosis can be an alternative, safe method to improve patient comfort without negatively affecting the diagnostic success of this test. Although performing hypnosis requires specific training, this technique is easily accessible to healthcare professionals, such as physicians or nurses. Institutes, such as the French Institute of Hypnosis, offer such training, with approximately 20days of training required to be qualified.

In our study, the TOE procedure was performed within 24hours of the hypnosis session. It could be argued that such a large time range may significantly reduce the effect of our strategy, and that hypnosis would be more effective if performed just before the TOE. While this may be true, we hoped to test a strategy for reducing discomfort in patients undergoing TOE that is new, efficient and – most importantly – feasible in daily practice. Echocardiographic laboratories are usually very busy, and it may not always be possible to perform hypnosis just before or during TOE. Our study demonstrates efficacy even when hypnosis is provided up to 24hours before TOE.

In the field of hypnosis, hypnoanalgesia and hypnotherapy are two distinct techniques. Hypnoanalgesia is used by health professionals to manage acute and chronic pain, stress and psychosomatic disorders, while hypnotherapy addresses the applications of hypnosis in psychotherapy, and is more specifically for psychologists and psychiatrists. In this protocol, we performed hypnoanalgesia only, and used it as a preconditioning strategy for the patient.

Study limitations

This study had some limitations. Patients were not blinded to group assignment; hypnosis requires active participation of the patient, so a double-blind study design was not possible. In addition our CTRL group did not receive any IV medication. Therefore, our data may be applicable only in labs where IV sedatives are not routinely used. However, in the other study mentioned earlier that looked at the effectiveness of hypnosis during TOE [6], a small group of patients received midazolam. Hypnosis was shown to be as effective as midazolam in improving patient comfort. Finally, the power of our study was less than initially calculated because patient recruitment was hampered by a larger population than expected being unable to understand French sufficiently for hypnosis to be performed (our hospital is located in a specific area in Paris where many new immigrants live).

Conclusions

Hypnosis could be an alternative or complementary method of improving patient comfort significantly during TOE, in patients who would otherwise receive only topical anaesthesia. The process is safe, and it seems promising in terms of helping to reduce side effects. Further evaluation of the relative values of hypnosis and intravenous sedatives may be warranted.

Disclosure of interest

The authors declare that they have no competing interest.Sources of funding : the trial was funded by the French Federation of Cardiology, the French Society of Cardiology and the Direction de la Recherche Clinique at Assistance publique–Hôpitaux de Paris (AP–HP).

References

Daniel W.G., Erbel R., Kasper W., and al. Safety of trans-esophageal echocardiography. A multicenter survey of 10,419 examinations Circulation 1991 ;  83 : 817-821 [cross-ref]
Wenzel R.R., Bartel T., Eggebrecht H., Philipp T., Erbel R. Central-nervous side effects of midazolam during trans-esophageal echocardiography J Am Soc Echocardiogr 2002 ;  15 : 1297-1300 [inter-ref]
Huet A., Lucas-Polomeni M.M., Robert J.C., Sixou J.L., Wodey E. Hypnosis and dental anesthesia in children: a prospective controlled study Int J Clin Exp Hypn 2011 ;  59 : 424-440 [cross-ref]
Lang E.V., Berbaum K.S., Pauker S.G., and al. Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice J Vasc Interv Radiol 2008 ;  19 : 897-905 [cross-ref]
Green J.P., Barabasz A.F., Barrett D., Montgomery G.H. Forging ahead: the 2003 APA Division 30 definition of hypnosis Int J Clin Exp Hypn 2005 ;  53 : 259-264 [cross-ref]
Souza de Lima A., da Mota Silveira C.A., Soares de Albuquerque E., and al. Applicability of hypnosis in trans-esophageal echocardiography Rev Bras Ecocardiogr Imagem Cardiovasc 2011 ;  24 : 25-30
Rhue J.W., Lynn S.J., Kirsch I. Handbook of clinical hypnosis  Washington, DC: American Psychological Association (1993). 
Maquet P., Faymonville M.E., Degueldre C., and al. Functional neuroanatomy of hypnotic state Biol Psychiatry 1999 ;  45 : 327-333 [cross-ref]
Rainville P., Duncan G.H., Price D.D., Carrier B., Bushnell M.C. Pain affect encoded in human anterior cingulate but not somatosensory cortex Science 1997 ;  277 : 968-971 [cross-ref]
Enqvist B., Bjorklund C., Engman M., Jakobsson J. Preoperative hypnosis reduces postoperative vomiting after surgery of the breasts. A prospective, randomized and blinded study Acta Anaesthesiol Scand 1997 ;  41 : 1028-1032 [cross-ref]
Faymonville M.E., Mambourg P.H., Joris J., and al. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study Pain 1997 ;  73 : 361-367 [cross-ref]
Williams A.R., Hind M., Sweeney B.P., Fisher R. The incidence and severity of postoperative nausea and vomiting in patients exposed to positive intra-operative suggestions Anaesthesia 1994 ;  49 : 340-342 [cross-ref]
Patterson D.R., Jensen M.P. Hypnosis and clinical pain Psychol Bull 2003 ;  129 : 495-521 [cross-ref]
Redd W.H., Montgomery G.H., DuHamel K.N. Behavioral intervention for cancer treatment side effects J Natl Cancer Inst 2001 ;  93 : 810-823 [cross-ref]
Spiegel D., Bloom J.R. Group therapy and hypnosis reduce metastatic breast carcinoma pain Psychosom Med 1983 ;  45 : 333-339 [cross-ref]
Montgomery G.H., Bovbjerg D.H., Schnur J.B., and al. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients J Natl Cancer Inst 2007 ;  99 : 1304-1312 [cross-ref]
Faymonville M.E., Fissette J., Mambourg P.H., Roediger L., Joris J., Lamy M. Hypnosis as adjunct therapy in conscious sedation for plastic surgery Reg Anesth 1995 ;  20 : 145-151
Ashton C., Whitworth G.C., Seldomridge J.A., and al. Self-hypnosis reduces anxiety following coronary artery bypass surgery. A prospective, randomized trial J Cardiovasc Surg (Torino) 1997 ;  38 : 69-75
Greenleaf M., Fisher S., Miaskowski C., DuHamel K. Hypnotizability and recovery from cardiac surgery Am J Clin Hypn 1992 ;  35 : 119-128 [cross-ref]
John M.E., Parrino J.P. Practical hypnotic suggestion in ophthalmic surgery Am J Ophthalmol 1983 ;  96 : 540-542 [cross-ref]
Montgomery G.H., David D., Winkel G., Silverstein J.H., Bovbjerg D.H. The effectiveness of adjunctive hypnosis with surgical patients: a meta-analysis Anesth Analg 2002 ;  94 : 1639-1645[table of contents].  [cross-ref]
Lang E.V., Benotsch E.G., Fick L.J., and al. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial Lancet 2000 ;  355 : 1486-1490 [cross-ref]
Elkins G., White J., Patel P., Marcus J., Perfect M.M., Montgomery G.H. Hypnosis to manage anxiety and pain associated with colonoscopy for colorectal cancer screening: case studies and possible benefits Int J Clin Exp Hypn 2006 ;  54 : 416-431 [cross-ref]
Leung F.W. Methods of reducing discomfort during colonoscopy Dig Dis Sci 2008 ;  53 : 1462-1467 [cross-ref]
Aeschbacher B.C., Portner M., Fluri M., Meier B., Luscher T.F. Midazolam premedication improves tolerance of trans-esophageal echocardiography Am J Cardiol 1998 ;  81 : 1022-1026 [inter-ref]
Cierpka K., Rickenbacher P., Burckhardt D., Luscher T.F. Subjective tolerance to trans-esophageal echocardiography Schweiz Rundsch Med Prax 1994 ;  83 : 308-315
Arrowsmith J.B., Gerstman B.B., Fleischer D.E., Benjamin S.B. Results from the American Society for Gastrointestinal Endoscopy/US Food and Drug Administration collaborative study on complication rates and drug use during gastrointestinal endoscopy Gastrointest Endosc 1991 ;  37 : 421-427 [cross-ref]
Bailey P.L., Pace N.L., Ashburn M.A., Moll J.W., East K.A., Stanley T.H. Frequent hypoxemia and apnea after sedation with midazolam and fentanyl Anesthesiology 1990 ;  73 : 826-830 [cross-ref]

1  The two first authors contributed equally to this work.


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