NCT05249855

Brief Summary

Investigators will measure the level of anxiety and fear of Covid during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

12 days

First QC Date

February 18, 2022

Last Update Submit

May 13, 2022

Conditions

D001452

Keywords

balneologyanxietyfear of SARS-CoV-2resiliencegeneral trust

Outcome Measures

Primary Outcomes (1)

  • Level of Anxiety

    Low level of anxiety

    10 days

Study Arms (1)

Longitudinal Study

OTHER

A longitudinal study of anxiety over the balneological treatment.

Behavioral: Psychological measurement

Interventions

Psychological measurementBEHAVIORAL

Psychological assessment

Longitudinal Study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • enrolled in balneological treatment

You may not qualify if:

  • not enrolled in the balneological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Angelo Gabriel Otesanu, BSC

CONTACT

0728983837otesanu.c.angelo-gabriel@s.fpse.unibuc.ro

Violeta Rotarescu, PhD

CONTACT

0722487140violeta.rotarescu@fpse.unibuc.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 18, 2022

First Posted

February 22, 2022

Study Start

May 20, 2022

Primary Completion

June 1, 2022

Study Completion

November 15, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05