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NCT Number: NCT07043530

Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students

The aim of the study is to investigate whether an online sleep hygiene programm is as effective as a face-to-face programm in improving sleep quality and mental health in medical students.

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Key information

Conditions

Sleep Quality Behavior Dyssomnias Health Behavior Mental Disorders Mental Health Nervous System Diseases Personal Satisfaction Psychological Well-Being Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Students, Medical

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a medical student enrolled in the Universidad Autonoma de Yucatan.
  • Having poor sleep quality according to the Pittsburgh Sleep Quality Index.
  • Having at least one electronic device with Internet access.
  • Having time availability.
  • Having signed the informed consent.

Exclusion criteria

  • Being in their year of Internship or Social Service.
  • Being pregnant.
  • Having children of any age.
  • Being under psychological therapy.
  • Regulary consuming sleep, depression or anxiety medication.
  • Working the night shift.

Treatment and study plan

In-person sleep hygiene-based intervention

Behavioral

The in-person sleep hygiene-based intervention will be delivered in 8 sessions by an sleep expert using digital resources, previously designed and expert validated. During the intervention, the following topics will be covered: (1) sleep hygiene generalities, (2) sleep and environment, (3) sleep and technology, (4) sleep and diet, (5) sleep and excercise, (6) sleep and stimulus control, (7) breathing techniques, (8) mindfulness. The sessions will be delivered twice a week with an approximated duration of 45 minutes each, until completed.

Online sleep hygiene-based intervention

Behavioral

The online sleep hygiene-based intervention will be delivered in 8 sessions through a self-paced educational platform; the content will be the same as in the in-person intervention, but tailored for use in digital learning platforms. The suggest completion time for each session will be 45 minutes. Although its self-paced nature, participants are required to complete it within one month, following the same timeline as the face-to-face arm.

Primary outcomes

  1. Sleep quality

    Time frame: 6 months

    This outcome will be measured by means of the Pittsburgh Sleep Quality Index, which is a self-administered 19-item questionnaire regarding perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep alterations, sleep medication use and daytime sleepiness. A score under 6 points suggests good sleep quality, while a score greater or equal to 6 point suggests poor sleep quality.

  2. Mental health

    Time frame: 6 months

    This outcome will be measured by means of the Positive Mental Health Scale (PMHS) and Symptom Checklist 90 Revised (SCL-90-R). The PMHS is a self-administered 83-item questionnaire regarding cognitive and emotional well-being, environmental mastery, social abilities, social sensitivity and empathy, physical well-being, self-reflection, psychological discomfort. The minimum score is 83 and the maximum score is 415; a higher score mean higher positive mental health.

    The SCL-90-R is a self-administered 90-item questionnaire regarding somatization, obssesive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. Each dimension is independently scored, with a higher grade meaning the pressence of psychological disorders in the evaluated dimension.

Other outcomes

  1. Sleep hygiene

    Time frame: 6 months

    This outcome will be evaluated using the Sleep Hygiene Index.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Morales-Robles, M.Sc.

CONTACT

[email protected]

+529993630074

Héctor A Rubio-Zapata, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universidad Autónoma de Yucatán

Other

Registry information

Official study title

Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students: a Comparison Between In-person and Online Learning

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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