An interventional study of Hypnosis and Placebo in Flutter, Atrial and Over 18 Years Old, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-10.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Supportive care
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.
Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.
Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.
The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.
223 studies on the registry are indexed under Atrial Flutter; 51 are open to participants now.
This study's enrollment of 116 is below the median of 150 across 155 interventional studies indexed under Atrial Flutter.
Browse Atrial Flutter studies →Poitiers University Hospital is the lead sponsor of 314 studies on the registry; 62 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery.
Other: Placebo
Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion. It is divided into three phases: * induction: attention of the patient fixed on an object or a part of the body, * the dissociation where the patient cuts off auditory, visual and tactile perceptions, * and finally the opening towards a hypnotic experience thanks to the imaginary.
Other: Hypnosis
Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
Global pain self-assessment during the procedure
Assessed with visual analogue pain scale
Time frame: Collected 45 min after the procedure
Anxiety during the procedure
Visual analog scale self-assessment
Time frame: Collected after the procedure
Morphine consumption
milligram
Time frame: Collected after the procedure
Patient sedation evaluation
numerical rating scale; Externally assessed by the electrophysiologist
Time frame: Collected after the procedure
Pain assessed prospectively during the procedure;
Numerical rating scale score
Time frame: Evaluated every 5 minutes during the procedure;
Ran from Oct 2017 to primary completion in Sep 2019, 23 months.
Of 55 interventional studies with no phase under Atrial Flutter, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 63. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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