NCT05867238

Brief Summary

The study aims to evaluate the effectiveness of stress management training provided to student nurse anaesthetists on: their level of chronic perceived stress in the last month, their level of acute perceived stress each day for one month, their level of resilience and their level of sleep quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

May 5, 2023

Last Update Submit

December 4, 2023

Conditions

Keywords

ResilienceAcute stresssleep qualityAnaesthetistchronic stress

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale 10

    The Perceived Stress Scale (PSS10 from 10 To 50) measures the degree to which respondents feel their lives are unpredictable, uncontrollable, and overloaded. A high score indicates more stress.

    at day 30

Secondary Outcomes (9)

  • Resilience

    at Day 0

  • Self-reported stress at the beginning of the workday.

    Each work day at the start of the shift. From day 0 to day 30.

  • Self-reported stress at the end of the workday.

    Every working day at the end of the shift. From day 0 to day 30.

  • Maximum self-reported stress of the workday.

    Every working day at the end of the shift. From day 0 to day 30.

  • The score of the Pittsburgh Sleep Quality Index (PSQI)

    at day 30

  • +4 more secondary outcomes

Study Arms (2)

Student nurse anaesthetists with no training in stress management

Student nurse anaesthetists who participated in the previous study: stress of anaesthesia professionals in the operating theatre and did not receive stress management training.

Student nurse anaesthetists with training in stress management

Volunteer nurse anaesthetist students who have received training in stress management this year.

Other: Training stress management

Interventions

The stress management training included 1 day and a half day. It was given by a therapist trained in transactional analysis and a trainer from the nurse anaesthetist school. The training was based on cognitive behavioural stress management training and the use of stress management exercises: cardiac coherence, mindfulness meditation, muscle relaxation, mental imagery.

Student nurse anaesthetists with training in stress management

Eligibility Criteria

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

Student nurse anaesthetist from the Grenoble school.

You may qualify if:

  • Student nurse anaesthetist

You may not qualify if:

  • Student objecting to the use of their personal information
  • Student on study leave.
  • Student on sick leave during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Stress, PsychologicalSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Julien Picard

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR
  • Yoann Zafiriou

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 19, 2023

Study Start

March 20, 2023

Primary Completion

June 15, 2023

Study Completion

September 15, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Locations