D001452TRATACONCT05249855
Balneotherapy and Anxiety During SARS-CoV-2 Pandemic
A study testing Psychological measurement in people with D001452, run by University of Bucharest.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- D001452
- What is being tested?
- Psychological measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 15 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- enrolled in balneological treatment
Who cannot join
- not enrolled in the balneological treatment
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- D001452
- Being tested
- Psychological measurement
- Keywords
- balneology, anxiety, fear of SARS-CoV-2, resilience, general trust
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological measurementBehavioural
Psychological assessment
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Study | Other | A longitudinal study of anxiety over the balneological treatment. Receives: Behavioral: Psychological measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Anxiety
Low level of anxiety
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start20 May 2022 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D001452Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bucharest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Violeta Stefania Rotarescu, University of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249855
- Sponsor's protocol ID
- UBucharest
- Acronym
- TRATACO
- Status last verified
- May 2022
- First submitted
- 18 Feb 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The database will be uploaded to a database website.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balneotherapy and Anxiety During SARS-CoV-2 Pandemic
- ClinicalTrials.gov ID
- NCT05249855
- Acronym / sponsor ID
- TRATACO / UBucharest
- Conditions
- D001452
- Keywords
- balneology, anxiety, fear of SARS-CoV-2, resilience, general trust
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of BucharestUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- General Trust mediates the relation between the level of anxiety at the beginning of the treatment and the end of the treament.
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Study | Other | Behavioral: Psychological measurementA longitudinal study of anxiety over the balneological treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- enrolled in balneological treatment
Key exclusion criteria (1 listed)
- not enrolled in the balneological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological measurementPsychological assessment | Behavioural | Longitudinal Study |
Primary outcome
Level of Anxiety
Time frame: 10 days
Low level of anxiety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided. The database will be uploaded to a database website.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological measurement in people with D001452, run by University of Bucharest.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angelo Gabriel Otesanu, BSC (0728983837 ext. 0040, otesanu.c.angelo-gabriel@s.fpse.unibuc.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Anxiety (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.