NCT07175142

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Oct 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

September 9, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

September 9, 2025

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

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.

    Baseline

Secondary Outcomes (1)

  • Prevalence of halitosis in obese patients before bariatric surgery

    Baseline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHalitosisSleep Wake DisordersStress, Psychological

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveNervous System DiseasesNeurologic ManifestationsMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 16, 2025

Study Start

October 1, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

September 16, 2025

Record last verified: 2025-09