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NCT Number: NCT06587555

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

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

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Key information

Conditions

Dysphagia Anxiety Anxiety Disorders Behavior Behavioral Symptoms Deglutition Disorders Depression Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Mental Disorders Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hasan Sadikin General Hospital

Bandung, West Java, 40161, Indonesia

Location contact

Regina Emmanuela Gusti Pratiwi, MD

CONTACT

vitriana biben, Dr, MD, physiatrist

CONTACT

[email protected]

62 815-6262-733

About this study

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 :

Underlying disease
Age
Duration of Rehabilitation Therapy
Type of Rehabilitation Theraphy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 contacts

Contact information is provided by the study sponsor or research team.

Regina Emmanuela Gusti Pratiwi

CONTACT

[email protected]

+6282119757188

Vitriana Biben

CONTACT

[email protected]

+628156262733

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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