Balneotherapy and Anxiety During SARS-CoV-2 Pandemic | NCT05249855

Studies
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic

NCT05249855

Sponsor

University of Bucharest

Status

Unknown status

Last Update Posted

May 19, 2022Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

D001452

Interventions

Psychological measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2022Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Nov 15, 2022Estimated

First Submitted Date

Feb 18, 2022

First Submission Date that Met QC Criteria

Feb 18, 2022

First Posted Date

Feb 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2022

Last Update Posted Date

May 19, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Investigators will measure the level of anxiety and fear of SARS-CoV-2 virus during the balneological treatment in patients. They are interested in the effect of general trust and resilience on the level of anxiety state.

A number of between 300 and 800 inpatients are expected to get involved in the study. They suffer from cardiovascular disease, osteoarthritis, respiratory diseases and many others.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Longitudinal Study	Other	A longitudinal study of anxiety over the balneological treatment.	Behavioral: Psychological measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psychological measurement	Behavioral	Psychological assessment	Longitudinal Study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of Anxiety	Low level of anxiety	10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

enrolled in balneological treatment

Exclusion Criteria:

not enrolled in the balneological treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angelo Gabriel Otesanu, BSC	Contact	0728983837	0040	otesanu.c.angelo-gabriel@s.fpse.unibuc.ro
Violeta Rotarescu, PhD	Contact	0722487140	0040	violeta.rotarescu@fpse.unibuc.ro

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

The database will be uploaded to a database website.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided