NCT05143203

Brief Summary

Its a prospective, non-interventional, single-center study, involving the human person evaluating the impact of self-hypnosis training on anxiety level and burn out in nursing and medical staff

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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

Study Start

First participant enrolled

October 12, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

November 22, 2021

Last Update Submit

August 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety disorder level evaluation M+6

    Generalized anxiety disorder screening scale (GAD7) will be measured 6 months after the start of training in self-hypnosis

    6 months after the training of the training of the first group

Secondary Outcomes (17)

  • Anxiety disorder level evaluation D-7

    7 days before the start of the training of the first group

  • Anxiety disorder level evaluation M+1

    1 month after the start of the training of the first group

  • Anxiety disorder level evaluation M+3

    3 months after the start of the training of the first group

  • Anxiety disorder level evaluation M+7

    7 months after the start of the training of the first group

  • Anxiety disorder level evaluation M+12

    12 months after the start of the training of the first group

  • +12 more secondary outcomes

Study Arms (3)

Staff trained in October 2021

22 nursing staff will follow two days of Self-Hypnosis training in October 2021

Other: Self-hypnosis training

Staff trained in May 2021

22 nursing staff will follow two days of Self-Hypnosis training in May 2021

Other: Self-hypnosis training

Control staff without training

22 nursing staff will not follow any training

Interventions

Self-hypnosis training will be conducted in two phases and the evaluation of effectiveness of the training will be measured using GAD7, PHQ9 and PROQOL questionnaires

Staff trained in May 2021Staff trained in October 2021

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing staff: doctors, nurses or nursing assistants

You may qualify if:

  • Nursing staff of the CHR Metz-Thionville: doctors, nurses or nursing assistants
  • Over 18 years old
  • Not objecting to participating in the study
  • Affiliated to a social security scheme

You may not qualify if:

  • Hospital staff
  • Not speaking and/or not understanding the French language.
  • Having disorders of higher functions.
  • With known history of schizophrenia.
  • Deaf or hard of hearing.
  • already trained in hypnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Régional Metz-Thionville

Metz, Grand Est, 57085, France

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionBurnout, Psychological

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorStress, Psychological

Study Officials

  • Nazmine GULER, MD

    CHR Metz Thionville Hopital de Mercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 3, 2021

Study Start

October 12, 2021

Primary Completion

April 13, 2022

Study Completion

May 2, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations