Sleep DisturbancesNCT06953102
Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students.
An observational study of Sleep Disturbances and Anxiety, run by Government Medical College, Patiala at 1 site in India.
Trial summary
Observational, Cross-sectional study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbances, Anxiety
- What is being tested?
- Survey using a questionnaire.
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- 10 Nov 2024to 30 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students of MBBS
Who may be able to join
- All the students of MBBS Phase-II.
Who cannot join
- Students with prior diagnosed Sleep disorders
- Students with prior diagnosed co-morbidities
- Students unable/unwilling to answer the question.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students: A Cross-sectional Study
Observational, Cross-sectional study
Read the detailed description
It was a cross-sectional study conducted in December 2024 with the consent of 200 undergraduate medical students of a tertiary care hospital affiliated medical college, who qualified as per the inclusion criteria.
Inclusion criteria:
All the students of MBBS Phase-II.
Exclusion criteria:
Students with prior diagnosed Sleep disorders Students with prior diagnosed co-morbidities Students unable/unwilling to answer the question.
- Conditions
- Sleep Disturbances, Anxiety
- Being tested
- Survey using a questionnaire.
- Keywords
- Sleep disturbances., Anxiety, Medical students, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Sleep quality
- Medical subject headings
- Parasomnias, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaire.Other
Survey was conducted to collect their responses to PSQI and BAI questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Phase-2 MBBS Students | The group included in Phase-2 MBBS Students i.e. 2nd year students in med school Receives: Other: Survey using a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Sleep Disturbances
The Pittsburgh Sleep Quality Index (PSQI) has been used to assess the pattern and the quality of sleep.[8] This questionnaire assesses sleep quality over a 1-month time interval based on self-report by the participant. PSQI differentiates 'Poor' from 'Good' sleep by measuring Seven Domains: Subjective Sleep Quality, Latency, Sleep Duration, Sleep Efficiency, Disturbances, Medication, and Daytime Dysfunction over the last month. The measure consists of 19 individual items, creating 7 components that produce one global score and take 5-10 minutes to complete.
Measured: 1 month
Assessment of Anxiety
To assess Anxiety, the Beck Anxiety Inventory (BAI)[9] has been used. This scale is a self-report measure of anxiety in children and adults, which asks the subject to rate 21 items on a scale of 0-3. The questions used in this measure ask the subject about common symptoms of anxiety that the subject had had during the past week. It is designed for individuals aged 17 and above and takes 5-10 minutes to complete. The total score is calculated by the standard mean of the responses to the 21 items. A score of 0-21 = low anxiety. A score of 22-35 = moderate anxiety. A Score of 36 and above signifies potentially concerning levels of anxiety.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start10 Nov 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbancesStudies 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Patiala
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yuvraj Kaushal, Government Medical College, Patiala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953102
- Sponsor's protocol ID
- Trg.9(310)2024/13198-201
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Association of Anxiety and Sleep Disturbances Among Medical Students: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06953102
- Acronym / sponsor ID
- Trg.9(310)2024/13198-201
- Conditions
- Sleep Disturbances, Anxiety
- Keywords
- Sleep disturbances., Anxiety, Medical students, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Government Medical College, PatialaOther government
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 May 2025 (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.
Observational, Cross-sectional study
Detailed description
It was a cross-sectional study conducted in December 2024 with the consent of 200 undergraduate medical students of a tertiary care hospital affiliated medical college, who qualified as per the inclusion criteria.
Inclusion criteria:
All the students of MBBS Phase-II.
Exclusion criteria:
Students with prior diagnosed Sleep disorders Students with prior diagnosed co-morbidities Students unable/unwilling to answer the question.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase-2 MBBS Students | – | Other: Survey using a questionnaire.The group included in Phase-2 MBBS Students i.e. 2nd year students in med school |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students of MBBS
Key inclusion criteria (1 listed)
- All the students of MBBS Phase-II.
Key exclusion criteria (3 listed)
- Students with prior diagnosed Sleep disorders
- Students with prior diagnosed co-morbidities
- Students unable/unwilling to answer the question.
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 |
|---|---|---|
| Survey using a questionnaire.Survey was conducted to collect their responses to PSQI and BAI questionnaires. | Other | Phase-2 MBBS Students |
Primary outcome
Assessment of Sleep Disturbances
Time frame: 1 month
The Pittsburgh Sleep Quality Index (PSQI) has been used to assess the pattern and the quality of sleep.[8] This questionnaire assesses sleep quality over a 1-month time interval based on self-report by the participant. PSQI differentiates 'Poor' from 'Good' sleep by measuring Seven Domains: Subjective Sleep Quality, Latency, Sleep Duration, Sleep Efficiency, Disturbances, Medication, and Daytime Dysfunction over the last month. The measure consists of 19 individual items, creating 7 components that produce one global score and take 5-10 minutes to complete.
Assessment of Anxiety
Time frame: 1 month
To assess Anxiety, the Beck Anxiety Inventory (BAI)[9] has been used. This scale is a self-report measure of anxiety in children and adults, which asks the subject to rate 21 items on a scale of 0-3. The questions used in this measure ask the subject about common symptoms of anxiety that the subject had had during the past week. It is designed for individuals aged 17 and above and takes 5-10 minutes to complete. The total score is calculated by the standard mean of the responses to the 21 items. A score of 0-21 = low anxiety. A score of 22-35 = moderate anxiety. A Score of 36 and above signifies potentially concerning 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 1 May 2025.
- Individual participant dataSharing planned: No. Participant Confidentiality
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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 Sleep Disturbances and Anxiety, run by Government Medical College, Patiala at 1 site in India.
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 3 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 1 May 2025. 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 India. 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?
Assessment of Sleep Disturbances (time frame: 1 month). The study lists 2 primary outcomes in all. 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 1 May 2025.