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NCT Number: NCT07175142

Halitosis, Sleep and Mental Health in Bariatric Surgery Candidates

This study aims to evaluate psychological distress, sleep quality, and halitosis in obese patients during the preoperative period of bariatric surgery. A total of 110 adults will be assessed using validated questionnaires and a portable halitosis detector. The results may contribute to improving strategies for comprehensive care in this population.

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Key information

About this study

This is an observational, cross-sectional study designed to assess the prevalence of psychological distress, sleep quality, and halitosis in obese patients who are candidates for bariatric surgery in the metropolitan region of Santos, Brazil. Participants (n=110) will be recruited during the preoperative assessment period at the Interprofessional Outpatient Clinic of Universidade Metropolitana de Santos (UNIMES).

Psychological distress will be measured using the Depression, Anxiety, and Stress Scale (DASS-21). Sleep quality will be evaluated with the Pittsburgh Sleep Quality Index (PSQI-BR). Halitosis will be assessed by clinical anamnesis, lingual coating index, and a KKCare Portable Detector.

The main outcomes are the prevalence of stress, anxiety, and depression; the prevalence of poor sleep quality; and the prevalence of halitosis in this patient population. The study will also investigate possible associations between these psychosocial and oral health variables. Data will be analyzed using descriptive statistics and binary logistic regression.

The findings are expected to support strategies to improve multidisciplinary care and enhance the quality of life of obese patients preparing for bariatric surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults ≥18 years with a diagnosis of obesity
  • Referred for psychological care at the "Rosinha Viegas" Interprofessional Outpatient Clinic during preoperative preparation for bariatric surgery (Brazilian public health system - SUS)

Exclusion criteria

  • Individuals with cognitive or neurological limitations that impair understanding or participation in the assessment procedures

Individuals who refuse or withdraw consent

Treatment and study plan

Primary outcomes

  1. Prevalence of psychological distress (stress, anxiety, and depression)

    Time frame: Baseline

    Psychological distress will be measured using the Depression, Anxiety, and Stress Scale - short form (DASS-21), validated for Portuguese. The scale consists of 21 items equally distributed among depression, anxiety, and stress domains. Scores will be classified according to standardized cutoff points.

Secondary outcomes

  1. Prevalence of halitosis in obese patients before bariatric surgery

    Time frame: Baseline

    Halitosis will be evaluated by clinical anamnesis, lingual coating index, and KKCare Portable Detector, which measures volatile sulfur compounds and provides classification across five levels of halitosis severity.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Universidade Metropolitana de Santos

Registry information

Official study title

Assessment of Psychological Distress, Sleep Quality, and Halitosis in Patients With Obesity: Protocol for an Observational Study in the Preoperative Period of Bariatric Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Sep 16, 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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