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临床试验/NCT07175142
NCT07175142尚未招募不适用

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

University of Nove de Julho0 个研究点目标入组 110 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
主要终点
Prevalence of psychological distress (stress, anxiety, and depression)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Individuals with cognitive or neurological limitations that impair understanding or participation in the assessment procedures
  • Individuals who refuse or withdraw consent

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Prevalence of halitosis in obese patients before bariatric surgery(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Kalil Bussadori

Principal Investigator

University of Nove de Julho

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