Clinical trial NCT06587555: Correlations Between Symptoms of Anxiety And/or Depression with Dysphagia Severity Level
Official title: Correlations Between Symptoms of Anxiety And/or Depression with Dysphagia Severity Level
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysphagia
Anxiety
Depression
Keywords: Dysphagia Severity Level
Anxiety
Depression
Dyspahgia
HADS
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Anxiety and / or Depression Symptoms Measure using HADS questionary
timeFrame: September 2024 - January 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: Jawa Barat
Study officials:
affiliation: University Padjajaran
name: Vitriana Biben
role: STUDY_DIRECTOR
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