Feasibility Trial of Functional Clothing, Moderate Exercise, and Health Information for Stress Reduction and Behavior Change in Okinawa
NCT07204483
Behavior, Behavioral Symptoms
Naha, Okinawa, Japan
View Trial DetailsNCT Number: NCT07175142
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.
Trial opening soon.
Get Notified18 year–90 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals who refuse or withdraw consent
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.
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.
University of Nove de Julho
Other
Assessment of Psychological Distress, Sleep Quality, and Halitosis in Patients With Obesity: Protocol for an Observational Study in the Preoperative Period of Bariatric Surgery
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