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

Not yet recruiting

• Conditions: Dysphagia; Anxiety; Depression

• Registration Number: NCT06587555
• Lead Sponsor: Universitas Padjadjaran

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

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Study Start: 2024-10-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety and / or Depression Symptoms Measure using HADS questionary	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

Trial Locations

Locations (1)

Hasan Sadikin General Hospital; 🇮🇩 Bandung, Jawa Barat, Indonesia