NCT06953102

Brief Summary

Observational, Cross-sectional study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 21, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

Sleep disturbances.AnxietyMedical studentsPittsburgh Sleep Quality Index (PSQI)Beck Anxiety Inventory (BAI)Sleep quality

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 month

Study Arms (1)

Phase-2 MBBS Students

The group included in Phase-2 MBBS Students i.e. 2nd year students in med school

Other: Survey using a questionnaire.

Interventions

Survey was conducted to collect their responses to PSQI and BAI questionnaires.

Phase-2 MBBS Students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Students of MBBS

You may qualify if:

  • \- All the students of MBBS Phase-II.

You may not qualify if:

  • Students with prior diagnosed Sleep disorders
  • Students with prior diagnosed co-morbidities
  • Students unable/unwilling to answer the question.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuvraj Kaushal

Patiāla, Punjab, 147001, India

Location

MeSH Terms

Conditions

ParasomniasAnxiety DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Yuvraj Kaushal

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 1, 2025

Study Start

November 10, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Participant Confidentiality

Locations