Emotional StressNCT05322811
Emotional State Among Patients With Neurological Disorders
An observational study of Emotional Stress and Emotional Depression, run by International Hellenic University at 1 site in Greece.
Trial summary
The purpose of the study was to examine the emotional state of the patients with neurological disorders. The evaluation was conducted with DASS-21 scale over 40 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Stress, Emotional Depression, Anxiety
- How many people
- 35 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2021to 1 Feb 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with neurological disorders
Who may be able to join
- patients with neurological disorders
Who cannot join
- not given concent
- Incomplete questionaire answers
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to examine the emotional state of the patients with neurological disorders. The evaluation was conducted with DASS-21 scale over 40 patients.
Read the detailed description
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.The DASS-21 should not be used to replace a face to face clinical interview.
- Conditions
- Emotional Stress, Emotional Depression, Anxiety, Neurologic Disorder
- Keywords
- stress, anxiety, depression, neurologic disorders
- Medical subject headings
- Stress, Psychological, Depression, Anxiety Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Adults patients with neurological disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional state score of the patients
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. Minimum score 0, maximum score 116+. The high score means a worse outcome.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Stress frequency at the participants
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Minimum score for stress is 0, maximum score 34+. The high score means a worse outcome.
Measured: through study completion, an average of 1 year
Depression frequency at the participants
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Minimum score for stress is 0, maximum score 28+. The high score means a worse outcome.
Measured: through study completion, an average of 1 year
Anxiety frequency at the participants
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Minimum score for stress is 0, maximum score 20+. The high score means a worse outcome.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgenia Trevlaki, International Hellenic University
- Investigators
- Alexandra-Hristara Papadopoulou, Study chair, PhD Professor of Physiotherapy at IHU, Head of the Postgraduate Programme, Pediatric Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322811
- Sponsor's protocol ID
- InternationalHellenicU
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional State Among Patients With Neurological Disorders
- ClinicalTrials.gov ID
- NCT05322811
- Acronym / sponsor ID
- InternationalHellenicU
- Conditions
- Emotional Stress, Emotional Depression, Anxiety, Neurologic Disorder
- Keywords
- stress, anxiety, depression, neurologic disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 12 Apr 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.
The purpose of the study was to examine the emotional state of the patients with neurological disorders. The evaluation was conducted with DASS-21 scale over 40 patients.
Detailed description
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.The DASS-21 should not be used to replace a face to face clinical interview.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | –Adults patients with neurological disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with neurological disorders
Key inclusion criteria (1 listed)
- patients with neurological disorders
Key exclusion criteria (2 listed)
- not given concent
- Incomplete questionaire answers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Emotional state score of the patients
Time frame: through study completion, an average of 1 year
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score. Minimum score 0, maximum score 116+. The high score means a worse outcome.
3 secondary outcomes
Stress frequency at the participants
Time frame: through study completion, an average of 1 year
Depression frequency at the participants
Time frame: through study completion, an average of 1 year
Anxiety frequency at the participants
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Alexandra-Hristara Papadopoulou study chair
PhD Professor of Physiotherapy at IHU, Head of the Postgraduate Programme, Pediatric Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Stress and Emotional Depression, run by International Hellenic University at 1 site in Greece.
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 2 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: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional state score of the patients (time frame: through study completion, an average of 1 year). 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 12 Apr 2022.