Mélisses Garden: Effect on Anxious State in Adult Patients Hospitalized in Psychiatry

Psychiatric Decompensation Clinical Trial

— JDM  

Official title:

Mélisses Garden: Effect of the Mediation by Care-garden on Anxious State in Adult Patients Hospitalized in Psychiatry (Prospective, Monocentric, Controlled, Randomized, Open in Two Parallel Groups Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666339
• Other study ID #: 1508192
• Secondary ID: 2016-A00057-44
• Status: Completed
• Phase: N/A
• Start date: September 30, 2016
• Est. completion date: August 27, 2021

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation". That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.

These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses.

That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks.

Description:

Each hospitalization leads to stress and anxiety. This is particularly true in psychiatry, because of "decompensation" that increases anxiety and fear. That is why therapeutic treatments are delivered quickly to treat these symptoms and to allow a better relationship with patients. This relationship patients-nursing staff called "therapeutic alliance" is needed in psychiatry. Moreover, other treatments added to the therapeutic ones are used, like mediation, to increase the patients' state of health.

These last years, numerous studies were based on hortitherapy or care-gardens. It consists in the use of plants with a medical staff (for example nurses). A lot demonstrated the efficacy of the care-gardens, but most of them showed methodological weaknesses : no control group, no randomization, few patients. Furthermore, these studies were not performed with feared patients hospitalized in psychiatry.

That is why the investigators would like to perform a randomized study, controlled, and they aim to demonstrate the efficacy of hortitherapy on anxiety in patients allowed in adult psychiatry for at least 4 weeks. This study will be performed on 190 patients who will be included in one of these groups:

• Control group : only usual care

• Hortitherapy group : 2 hortitherapy sessions/week during 4 weeks, added at the usual care.

Anxiety will be evaluated with HAD-A scale that is a brief questionnaire (2 at 6 minutes). HAD-A is very sensitive at the modifications and allows to follow the evolution of the anxiety. This scale is easy to use by the nursing staff and shows an excellent reliability, by the way really adapted to this study. On another hand researchers will also focus on the effects on the therapeutic alliance and the persistence of the effects at week 8.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum 18 years old

• Adult patient in complete hospitalization in psychiatry at CHU St-Etienne, with an anxiety score > 8 at HAD-A (cut off)

• Patient with hospitalization programmed for at least 1 month

• Patient able to start a mediation

• Antitetanic cover up to date (quick test performed before the randomization)

• Patients who have given their informed consent before participation in the study or for patients under supervision , informed consent of the guardian

• Patient affiliated or entitled to a social security scheme

Exclusion Criteria:

• Rejection of the randomization

• Inability to complete the scales whatever the cause of this failure (language other than French, mental retardation ...).

• Patient whose behavior evaluated by the psychiatrist does not allow the indication of a mediation.

• Patient who already participated in the mediation of horticultural therapy

Related Conditions & MeSH terms

• Psychiatric Decompensation

Intervention

Other:
• Usual care
Usual care : drug therapy, nurse and physician consultations.

Behavioral:
• Hortitherapy
2 hortitherapy sessions/week during 4 weeks, added at the usual care.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of the mediation by care-garden on anxious state in adult patients hospitalized in psychiatry	Score to HAD (anxiety scale)	1 Month