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Clinical Trials/NCT06587555
NCT06587555
Not yet recruiting
Not Applicable

Correlations Between Symptoms of Anxiety And/or Depression with Dysphagia Severity Level

Universitas Padjadjaran1 site in 1 country30 target enrollmentOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dysphagia
Sponsor
Universitas Padjadjaran
Enrollment
30
Locations
1
Primary Endpoint
Anxiety and / or Depression Symptoms Measure using HADS questionary
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this observational study is to know any CORRELATIONS BETWEEN SYMPTOMS OF ANXIETY AND / OR DEPRESSION WITH DYSPHAGIA SEVERITY LEVEL in is all of the new or ongoing patients with dysphagia in the Neurorehabilitation Department at Hasan Sadikin General Hospital Bandung and who meet the inclusion and exclusion criteria. The main questions it aims to answer are:

Hypothesis 1 H0 : There is no correlation between increased severity of dysphagia and higher levels of anxiety symptoms H1 : There is a correlation between increased severity of dysphagia and higher levels of anxiety

Hypothesis 2 H0 : There is no correlation between increased severity level of dysphagia and higher level of depression symptoms H1 : There is a correlation between increased severity of dysphagia and higher levels of depression

Hypothesis 3 H0 : There is no correlation between increased severity level of anxiety and dysphagia and higher level of depression symptoms H1 : There is a correlation between increased severity of anxiety and dysphagia and higher levels of depression

Detailed Description

This study is an analytical observational study with a cross-sectional design, then correlation analysis was carried out, to analyse the correlation between Severity level of dysphagia with anxiety and / or depression. This Study performed at Hasan Sadikin Hospital between August 2024 - March 2025 Study Subject : The target population for this study is all of the new or ongoing patients with dysphagia in the Neurorehabilitation Department at Hasan Sadikin General Hospital Bandung and who meet the inclusion and exclusion criteria. Inclusion criteria : * Participants aged 18 years and above. * Individuals diagnosed with dysphagia by a qualified healthcare professional * Participants with documented anxiety and/or depression symptoms were assessed using standardized psychological assessments * Willing to participate Exclusion criteria : Participants who have MOCA INA \< 18 Participants with severe malnutrition, showed by BMI WHO Asia Pacific \< 18.5 Participants with unstable hemodynamics, GCS \< 15 Participants who had a history of diagnosed anxiety and / or depression Participants who had a history of using an antipsychotic drug Sample Size Determination : The sample size in this study was determined using correlation analysis, to see the correlation between variables, with a minimum number of samples of 30 research subjects obtained. Confounding Factors : 1. Underlying disease 2. Age 3. Duration of Rehabilitation Therapy 4. Type of Rehabilitation Theraphy

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Vitriana Biben

Dr. Vitriana Biben, dr., Sp.K.F.R, NM(K)

Universitas Padjadjaran

Eligibility Criteria

Inclusion Criteria

  • Participants aged 18 years and above.
  • Individuals diagnosed with dysphagia by a qualified healthcare professional
  • Participants with documented anxiety and/or depression symptoms were assessed using standardized psychological assessments
  • Willing to participate

Exclusion Criteria

  • Participants who have MOCA INA \< 18
  • Participants with severe malnutrition, showed by BMI WHO Asia Pacific \< 18.5
  • Participants with unstable hemodynamics, GCS \< 15
  • Participants who had a history of diagnosed anxiety and / or depression
  • Participants who had a history of using an antipsychotic drug

Outcomes

Primary Outcomes

Anxiety and / or Depression Symptoms Measure using HADS questionary

Time Frame: September 2024 - January 2025

Hospital Anxiety and Depression Questionnaire (HADS) are ranging from 0-7 points meaning no depression/ anxiety cases (ie, non- cases), 8-10 points representing borderline or doubtful cases, and ≥11 points suggesting anxiety or depressive cases

Study Sites (1)

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