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

NCT ID: NCT06587555

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-01

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

Conditions

Dysphagia; Anxiety; Depression

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitas Padjadjaran

OTHER

Sponsor Role: lead

Responsible Party

Vitriana Biben

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vitriana Biben

Role: STUDY_DIRECTOR

University Padjajaran

Locations

Hasan Sadikin General Hospital

Bandung, West Java, Indonesia

Countries

Indonesia

Central Contacts

Vitriana Biben

Role: CONTACT

vitriana@unpad.ac.id

+628156262733

Regina Emmanuela Gusti Pratiwi

Role: CONTACT

reginaemmanuela@gmail.com

+6282119757188

Facility Contacts

vitriana biben, Dr, MD, physiatrist

Role: primary

vitriana@unpad.ac.id

62 815-6262-733

Regina Emmanuela Gusti Pratiwi, MD

Role: backup

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Related Links

https://www.who.int/news-room/fact-sheets/detail/anxiety-disorders

World Health Organization. Anxiety disorders

Other Identifiers

IKFR-202408.02

Identifier Type: -

Identifier Source: org_study_id