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DysphagiaNCT06587555

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

An observational study of Dysphagia and Anxiety, run by Universitas Padjadjaran at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dysphagia, Anxiety, Depression
How many people
30 participants
Where
1 siteIndonesia
Study dates
1 Oct 2024to 1 Mar 2025
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Vitriana Biben contact

+628156262733

vitriana@unpad.ac.id

Regina Emmanuela Gusti Pratiwi contact

+6282119757188

reginaemmanuela@gmail.com

Indonesia1 site

  • Hasan Sadikin General Hospital

    Bandung, West Java, 40161

    vitriana biben, Dr, MD, physiatrist, 62 815-6262-733, vitriana@unpad.ac.id

    Regina Emmanuela Gusti Pratiwi, MD

Other trials in Indonesia

About this study

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

Read more

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

Read the 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
Keywords
Dysphagia Severity Level, Anxiety, Depression, Dyspahgia, HADS
Medical subject headings
Deglutition Disorders, Anxiety Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety and / or Depression Symptoms Measure using HADS questionary

    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

    Measured: September 2024 - January 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Oct 2024 (estimated)
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
30 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587555
Sponsor's protocol ID
IKFR-202408.02
Status last verified
Aug 2024
First submitted
4 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28965240

  • Doruk C, Mocchetti V, Rives H, Christos P, Rameau A. Correlations Between Anxiety and/or Depression Diagnoses and Dysphagia Severity. Laryngoscope. 2024 May;134(5):2115-2120. doi: 10.1002/lary.31164. Epub 2023 Nov 9.

    PubMed 37942834

  • DiMatteo MR, Lepper HS, Croghan TW. Depression is a risk factor for noncompliance with medical treatment: meta-analysis of the effects of anxiety and depression on patient adherence. Arch Intern Med. 2000 Jul 24;160(14):2101-7. doi: 10.1001/archinte.160.14.2101.

    PubMed 10904452

  • Adkins C, Takakura W, Spiegel BMR, Lu M, Vera-Llonch M, Williams J, Almario CV. Prevalence and Characteristics of Dysphagia Based on a Population-Based Survey. Clin Gastroenterol Hepatol. 2020 Aug;18(9):1970-1979.e2. doi: 10.1016/j.cgh.2019.10.029. Epub 2019 Oct 24.

    PubMed 31669055

  • Karisik A, Dejakum B, Moelgg K, Komarek S, Toell T, Mayer-Suess L, Pechlaner R, Kostner S, Sollereder S, Kiechl S, Rossi S, Schoenherr G, Lang W, Kiechl S, Knoflach M, Boehme C; STROKE-CARD Registry study group. Association between dysphagia and symptoms of depression and anxiety after ischemic stroke. Eur J Neurol. 2024 May;31(5):e16224. doi: 10.1111/ene.16224. Epub 2024 Feb 2.

    PubMed 38308469

  • Tanaka M, Szabo A, Vecsei L. Integrating Armchair, Bench, and Bedside Research for Behavioral Neurology and Neuropsychiatry: Editorial. Biomedicines. 2022 Nov 22;10(12):2999. doi: 10.3390/biomedicines10122999.

    PubMed 36551755

  • Mori T, Wakabayashi H, Kishima M, Itoda M, Fujishima I, Kunieda K, Ohno T, Shigematsu T, Oshima F, Ogawa N, Nishioka S, Momosaki R, Shimizu A, Saito Y, Yamada M, Ogawa S. Association between Inflammation and Functional Outcome in Patients with Sarcopenic Dysphagia. J Nutr Health Aging. 2022;26(4):400-406. doi: 10.1007/s12603-022-1769-9.

    PubMed 35450997

  • Li Y, Hu N, Yang D, Oxenkrug G, Yang Q. Regulating the balance between the kynurenine and serotonin pathways of tryptophan metabolism. FEBS J. 2017 Mar;284(6):948-966. doi: 10.1111/febs.14026. Epub 2017 Feb 20.

    PubMed 28118532

Questions about this trial

What is this clinical trial studying?

An observational study of Dysphagia and Anxiety, run by Universitas Padjadjaran at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vitriana Biben (+628156262733, vitriana@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety and / or Depression Symptoms Measure using HADS questionary (time frame: September 2024 - January 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06587555, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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