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

Обзор

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

Подробное описание

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

Первичные конечные точки

• Anxiety and / or Depression Symptoms Measure using HADS questionary [Срок оценки: September 2024 - January 2025]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Индонезия · 1 центр

• Hasan Sadikin General Hospital — Bandung

Публикации

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• Brenes GA. Anxiety, depression, and quality of life in primary care patients. Prim Care Companion J Clin Psychiatry. 2007;9(6):437-43. doi: 10.4088/pcc.v09n0606. PMID 18185823
• Verdonschot RJ, Baijens LW, Serroyen JL, Leue C, Kremer B. Symptoms of anxiety and depression assessed with the Hospital Anxiety and Depression Scale in patients with oropharyngeal dysphagia. J Psychosom Res. 2013 Nov;75(5):451-5. doi: 10.1016/j.jpsychores.2013.08.021. Epub 2013 Sep 3. PMID 24182634
• Krekeler BN, Broadfoot CK, Johnson S, Connor NP, Rogus-Pulia N. Patient Adherence to Dysphagia Recommendations: A Systematic Review. Dysphagia. 2018 Apr;33(2):173-184. doi: 10.1007/s00455-017-9852-9. Epub 2017 Sep 30. PMID 28965240

Идентификаторы

NCT: NCT06587555 · IKFR-202408.02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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