the Activating Consciousness Technique (Hypnosis) in General Practice

Anxiety Clinical Trial

— MG HYPNOSIS  

Official title:

Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649762
• Other study ID #: 69HCL20_0202
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: October 2022

Study information

• Verified date: December 2020
• Source: Hospices Civils de Lyon
• Contact: Lidwine LAURENT
• Phone: 0626550636
• Email: lidwine.laurent[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anxiety is an emotion considered unpleasant but resulting from a normal phenomenon. It corresponds to an adaptive response to events, to stress and helps to ensure our survival.

On the other hand, it becomes embarrassing when it becomes uncontrollable. It can even lead to interfere with activities of daily living. Thus, we can speak of anxiety disorder.

Anxiety disorders are among the most prevalent psychiatric disorders. They are often associated with other comorbidities such as depression, which makes them more difficult to treat and diagnose.

Different treatments are offered to best treat the patient with anxiety : drug treatment (antidepressants, anxiolytics) ; non-drug (psychotherapy, meditation, cognitive behavioral therapies).

The emergence of hypnosis in medical practice in recent years seems to be a technique that can bring benefits to the patient.

A review of clinical studies does not seem to find a benefit to hypnosis in anxiety disorders. In contrast, a study in children with school phobia showed the effectiveness of hypnosis. The limits addressed by this review seem to relate to the number of people included in the studies. Contrariwise, it has been pointed out that hypnosis can have a beneficial effect in the long term.

Thus, it seems interesting to deepen this technique in the practice of a general practitioner exercising the activating consciousness technique in anxiety.

The study will be composed of patients presenting with anxiety and consulting their general practitioner, with: Group 1, patients consulting a doctor not practicing hypnosis Versus Group 2, patients consulting a doctor practicing hypnosis.

During the first consultation and the following 2 consultations scheduled by the general practitioner (spaced 15 days apart), the following data are noted, in addition to the monitoring usually performed by the doctor:

1. COVI scale

2. Comfort scale 0 to 10

3. Management: drugs, TAC, others

4. Quality of life survey SF36 Patients will be called back at 6 months to reassess quality of life (self-administered survey SF 36) The primary endpoint is to evaluated the change of anxiety from inclusion (J0) to 6 months using COVI scale in the two different groups.

For secondary endpoints, the consumption of drug medicine will be quantified and the quality of life will be measured using Quality of life survey SF36.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or Female over 18

• Anxiety patient

• Patient who can return for consultation regularly and can be reached by phone

• Patient Not Opposing Participation In Study

Exclusion Criteria:

• Follow-up deemed impossible by the investigator

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• activating consciousness technique (hypnosis)
activating consciousness technique (hypnosis)

Locations

Country	Name	City	State
France	Dr Stéphane FOLACHER	Bourg-en-Bresse
France	Dr Céline HUMBERT	Lyon
France	Dr Matthieu DEMOURGUES	Lyon
France	Dr Christian SAINT-CYR	Saint-Étienne-du-Bois
France	Dr Aurélien BARADEL	Saint-Martin-du-Fresne
France	Dr Maud BINARD	Villereversure

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Pelissolo A. [Hypnosis for anxiety and phobic disorders: A review of clinical studies]. Presse Med. 2016 Mar;45(3):284-90. doi: 10.1016/j.lpm.2015.12.002. Epub 2016 Mar 2. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the score of anxiety from inclusion (J0) to 6 months evaluated byvia COVI scale	COVI scale (questionnaire completed by patients) is a scale that permits to evaluate the clinical anxiety. The range is 0-100. The higher the score, the more the anxiety. The clinical cut-off score is 30.	6 months