AnxietyNCT05942898
When the Alarm Goes Off, You're Already Awake
An observational study of Anxiety, run by International Institute of Behavioral Medicines at 1 site in Italy.
Trial summary
This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. It consists of a short self-administered questionnaire which will be given to workers to complete. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety
- What is being tested?
- The present study does not contain any intervention
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 25 Sep 2023to 31 Dec 2023
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: Workers (any kind)
Who may be able to join
- Being workers (any type)
- Adult age
- Ability to understand the Italian language
Who cannot join
- People who do not use the alarm clock to wake up in the morning
- Refuse to adhere to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: When the Alarm Goes Off, You're Already Awake!
This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. It consists of a short self-administered questionnaire which will be given to workers to complete. Relationships between workers' answers and anxiety will be evaluated.
Read the detailed description
This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. Literature found out that anticipatory anxiety plays a key role as for awakening quality (experiencing self). This evaluation could change at the end of the working day due to biased memory effects (remembering self).
In Literature there are not studies which investigate the relationships between time to awakening before the alarm sounds and anxiety.
The study consists of a short self-administered questionnaire which will be given to workers to complete. In more details, the survey is made of five questions collecting information on type of work, people who use an alarm, time of awakening before the alarm goes off, feelings on the moment of awakening, and feelings as for the working day spent. Further, participants will have to complete an anxiety self-administered questionnaire on anxiety, and namely the Zung Self-Rating Anxiety Scale.
Descriptive statistics will be presented by taking into account the characteristics of the sample being investigated. Statistical correlations between workers' answers and anxiety will be also evaluated.
This study's usefulness relies on detecting on advance mood disorders (like anxiety is) and maladaptive behaviors, in order to build persons' positive routines (i.e. well-being) and improve their productive quality at work.
- Conditions
- Anxiety
- Being tested
- The present study does not contain any intervention
- Keywords
- Behavioral Medicine, Anticipatory anxiety, Alarm, Work, Experiencing self, Remembering self
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The present study does not contain any interventionOther
The present study does not contain any intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Zung
Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety
Measured: At the specific time of the scale assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start25 Sep 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Institute of Behavioral Medicines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942898
- Sponsor's protocol ID
- 2023-02
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
PubMed 32111187
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When the Alarm Goes Off, You're Already Awake!
- ClinicalTrials.gov ID
- NCT05942898
- Acronym / sponsor ID
- 2023-02
- Conditions
- Anxiety
- Keywords
- Behavioral Medicine, Anticipatory anxiety, Alarm, Work, Experiencing self, Remembering self
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- International Institute of Behavioral MedicinesUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jul 2023 (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.
This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. It consists of a short self-administered questionnaire which will be given to workers to complete. Relationships between workers' answers and anxiety will be evaluated.
Detailed description
This is a behavioral observational study aimed at evaluating the impact that anxiety exerts on working people at the moment of awakening in the morning. Literature found out that anticipatory anxiety plays a key role as for awakening quality (experiencing self). This evaluation could change at the end of the working day due to biased memory effects (remembering self).
In Literature there are not studies which investigate the relationships between time to awakening before the alarm sounds and anxiety.
The study consists of a short self-administered questionnaire which will be given to workers to complete. In more details, the survey is made of five questions collecting information on type of work, people who use an alarm, time of awakening before the alarm goes off, feelings on the moment of awakening, and feelings as for the working day spent. Further, participants will have to complete an anxiety self-administered questionnaire on anxiety, and namely the Zung Self-Rating Anxiety Scale.
Descriptive statistics will be presented by taking into account the characteristics of the sample being investigated. Statistical correlations between workers' answers and anxiety will be also evaluated.
This study's usefulness relies on detecting on advance mood disorders (like anxiety is) and maladaptive behaviors, in order to build persons' positive routines (i.e. well-being) and improve their productive quality at work.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Workers (any kind)
Key inclusion criteria (3 listed)
- Being workers (any type)
- Adult age
- Ability to understand the Italian language
Key exclusion criteria (2 listed)
- People who do not use the alarm clock to wake up in the morning
- Refuse to adhere to the study
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 |
|---|---|---|
| The present study does not contain any interventionThe present study does not contain any intervention | Other | – |
Primary outcome
Zung
Time frame: At the specific time of the scale assessment
Zung Self-Rating Anxiety Scale; score 20-80 with higher estimates indicating higher levels of anxiety
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 6 Feb 2024.
- Results publication: PubMed 32111187Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anxiety, run by International Institute of Behavioral Medicines at 1 site in Italy.
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 3 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 6 Feb 2024. 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 Italy. 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?
Zung (time frame: At the specific time of the scale assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942898, which also lists 1 linked publication.
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 6 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.