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Not yet recruitingNCT07175142Updated Sep 16, 2025

Halitosis, Sleep and Mental Health in Bariatric Surgery Candidates

An observational study in Obesity, Bariatric Surgery Candidate and Halitosis, sponsored by University of Nove de Julho. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by University of Nove de Julho · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
110
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Bariatric Surgery Candidate
  • Halitosis
  • Sleep Disorder
  • Stress, Psychological
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Obese adult patients in the metropolitan region of Santos, Brazil, who are undergoing multidisciplinary assessment in preparation for bariatric surgery within the Brazilian public health system (SUS).

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

Exclusion Criteria:

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

Individuals who refuse or withdraw consent

04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

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

    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.

    Time frame: Baseline

Secondary outcomes

  1. Prevalence of halitosis in obese patients before bariatric surgery

    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.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07175142
Lead sponsor
University of Nove de Julho
Collaborators
Universidade Metropolitana de Santos
Responsible party
Sandra Kalil Bussadori (Principal Investigator, University of Nove de Julho) — Principal investigator
First posted
Sep 16, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Mar 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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