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Completed

NCT Number: NCT02666339

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

Usual care : drug therapy, nurse and physician consultations.

Hortitherapy

Behavioral

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

Primary outcomes

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

    Time frame: 1 Month

    Score to HAD (anxiety scale)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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)

Acronym: JDM

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2016
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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