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Not yet recruiting NCT06587555

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

Observational Dysphagia Anxiety Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dysphagia, Anxiety, Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Indonesia · 1 center
  • Hasan Sadikin General Hospital — Bandung

Publications

  • Matsuo K, Palmer JB. Anatomy and physiology of feeding and swallowing: normal and abnormal. Phys Med Rehabil Clin N Am. 2008 Nov;19(4):691-707, vii. doi: 10.1016/j.pmr.2008.06.001. PMID 18940636
  • Kwon S, Cha S, Kim J, Han K, Paik NJ, Kim WS. Trends in the incidence and prevalence of dysphagia requiring medical attention among adults in South Korea, 2006-2016: A nationwide population study. PLoS One. 2023 Jun 28;18(6):e0287512. doi: 10.1371/journal.pone.0287512. eCollection 2023. PMID 37379287
  • Kim DY, Park HS, Park SW, Kim JH. The impact of dysphagia on quality of life in stroke patients. Medicine (Baltimore). 2020 Aug 21;99(34):e21795. doi: 10.1097/MD.0000000000021795. PMID 32846813
  • Bendsen BB, Jensen D, Westmark S, Krarup AL, Riis J, Melgaard D. The Quality of Life in Citizens with Oropharyngeal Dysphagia-A Cross-Sectional Study. J Clin Med. 2022 Jul 20;11(14):4212. doi: 10.3390/jcm11144212. PMID 35887975
  • Bushuven S, Niebel I, Huber J, Diesener P. Emotional and Psychological Effects of Dysphagia: Validation of the Jugendwerk Dysphagia Emotion and Family Assessment (JDEFA). Dysphagia. 2022 Apr;37(2):375-391. doi: 10.1007/s00455-021-10289-1. Epub 2021 Apr 4. PMID 33817751
  • 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

Identifiers

NCT: NCT06587555 · IKFR-202408.02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗