Halitosis, Sleep and Mental Health in Bariatric Surgery Candidates

NCT07175142 — Not yet recruiting, 110 participants, University of Nove de Julho

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

Registry	NCT07175142
Status	Not yet recruiting
Study type	Observational
Enrollment	110 (Estimated)
Sponsor	University of Nove de Julho (Other); collaborators: Universidade Metropolitana de Santos
Conditions	Obesity, Bariatric Surgery Candidate, Halitosis, Sleep Disorder, Stress, Psychological
Dates	start 2025-10-01 (estimated), primary completion 2026-03-30 (estimated), completion 2026-06-30 (estimated), first posted 2025-09-16, last updated 2025-09-16

-Summary

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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+Detailed description

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.

+Outcome measures

Primary outcomes

Prevalence of psychological distress (stress, anxiety, and depression) [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

Prevalence of halitosis in obese patients before bariatric surgery [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.

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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