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临床试验/NCT02977767
NCT02977767撤回不适用

Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients: a Pilot Study

Centre Hospitalier Universitaire de la Réunion0 个研究点开始时间: 2018年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Time to change the tracheal cannula using conversational hypnosis

研究概览

简要总结

Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed every day from once to several times depending on the patient's secretions production and it is usually replaced every week. The second replacement takes place about 10 days after surgery. Patient education takes place at every replacement in order to empower him/her and in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th replacement, at best. Because of the risks and complications related to tracheotomy and because of the concerned vital function, the cannula replacement leads to anxiety especially during the first replacements. Usual patient's anxiety management consists in reassuring the patient during the replacement. In other situations, patients' anxiety management would be drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to maintain optimal breathing, they are not used in first intention. Our choice is to use conversational hypnosis during cannula replacement as it has already demonstrated interesting effects in pain and anxiety. Conversational hypnosis does not present an induction phase like in so-called hypnosis, it aims at leading the patient to perceive his/her world differently with only a slight consciousness alteration.

详细描述

Once the informed consent form is signed and when the cannula replacement has to be performed, conversational hypnosis session will start right from the patient's room entrance and end when the nurse will come out. The care will consist in aspiration, cleaning and finally replacement of the cannula. Adverse events are expected to be related to the cannula replacement itself: patients will be followed-up during a maximum of 7 days with one follow-up visit which will take place 2 hours after cannula replacement and a second one which can take place from the day after the replacement up to just before the following replacement.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients hospitalised in the Ear, Nose, Throat - specialties surgery department
  • •aged of 18 years old and more
  • •having a tracheotomy following an upper aero-digestive tracts obstruction
  • •presenting a tracheal cannula which can be replaced by paramedical staff
  • •able to communicate to give their consent
  • •member or beneficiary of a social security assurance
  • •having given a signed informed consent form

排除标准

  • •patients presenting a hearing loss (preventing from hearing properly the words pronounced during conversational hypnosis)
  • •who do not understand French
  • •who are under curators/guardianship
  • •presenting dementia
  • •autonomous in their cannula replacement
  • •having already participated in the study

研究组 & 干预措施

Conversational hypnosis

Experimental

Use of conversational hypnosis during the tracheal cannula replacement

干预措施: Conversational hypnosis (Procedure)

结局指标

主要结局

Time to change the tracheal cannula using conversational hypnosis

时间窗: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).

Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed. As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence "now we start" is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck. The time between the two indicators will be reported in the Case Report Form in seconds.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

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