NCT02666339

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

4.9 years

First QC Date

January 15, 2016

Last Update Submit

November 16, 2021

Conditions

Psychiatric Decompensation

Keywords

HortitherapyCare-gardenAnxietyTherapeutic alliance

Outcome Measures

Primary Outcomes (1)

  • Effect of the mediation by care-garden on anxious state in adult patients hospitalized in psychiatry

    Score to HAD (anxiety scale)

    1 Month

Study Arms (2)

Hortitherapy group

EXPERIMENTAL

Hortitherapy + Usual care

Behavioral: Hortitherapy

Control group

ACTIVE COMPARATOR

Usual care

Other: Usual care

Interventions

Usual careOTHER

Usual care : drug therapy, nurse and physician consultations.

Control group
HortitherapyBEHAVIORAL

2 hortitherapy sessions/week during 4 weeks, added at the usual care.

Hortitherapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Joubert A, Jankowski-Cherrier B, Rossi A, Teyssier L, Suraud V, Presle E, Pommier R, Massoubre C, Verot E. Impact of horticultural therapy on patients admitted to psychiatric wards, a randomised, controlled and open trial. Sci Rep. 2024 Jun 22;14(1):14378. doi: 10.1038/s41598-024-65168-0.

    PMID: 38909093DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Catherine MASSOUBRE, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2016

First Posted

January 28, 2016

Study Start

September 30, 2016

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)