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.
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 30 minutes 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.
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 ). Moderate or complete general anaesthesia cannot always be performed, as it may adversely affect the diagnostic value of the procedure and/or patient safety . 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 . In a hypnotic state, a patient’s sensitivity to a stimulus and his or her emotional interpretation of this stimulus are dissociated , 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 < 18 years 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 24 hours 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 30 minutes 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 24 hours 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 24 hours, 7 days, 1 month and 3 months 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 Chi 2 test or Fisher’s exact probability test (when conditions of validity of the Chi 2 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).
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