Post-stroke DepressionNCT05241782
The Effect of Auricular Acupressure on the Improvement of Anxiousness, Depression and Heart Rate Variability in Stroke Patients
A study testing auricular acupressure in people with Post-stroke Depression and Auricular Acupressure, run by Cathay General Hospital at 1 site in Taiwan.
Trial summary
Heart rate variability (HRV) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. Anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post-stroke Depression, Auricular Acupressure
- What is being tested?
- auricular acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 May 2021to 13 Aug 2022
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years old
- Within 24 hours of arriving at the hospital with the first symptoms of stroke
- Hemorrhagic stroke:nontraumatic hemorrhagic stroke and Intracerebral Hemorrhage score 0-1
- Infarct stroke:National Institutes of Health Stroke Scale less than 30
- Able to express themselves through oral or written communication
- Hospital Anxiety and Depression Scale Score equal to or greater than 11
Who cannot join
- Previous diagnosis of arrhythmia
- Mental illness, dementia, Alzheimer's disease, or possible complete paralysis on imaging
- Subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage
- Patients with acute myocardial infarction
- There is a wound or lesion at the ear auricular point
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cathay General Hospital
Taipei, 106
Chen Hsin-Tung, University, 886-83702367, junyi0118.lai@gmail.com
Wang Mei-Hua, PhD, 886-28227101 ext. 3166, meihua@ntunhs.edu.tw
About this study
Official title: Cathay General Hospital
Heart rate variability (HRV) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. Anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. The influence of acupressure over the auricle on the HRV, anxiousness and depressive mood have yet to be verified. The investigators aimed to study the effect on auricular acupressure treatment between the different trending of HRV, anxiety and depression and their correlations.
This is a randomized control study, consisted of 70 patients with post-stroke depressive mood, from both CGH and Xizhi Cathay hospital in Taiwan. HRV analysis is performed on the first 24 hours, and on a weekly basis for a total of 6 weeks. The included depressed patients were defined by the "Hospital Anxiety and Depression Scale" and weekly will be undertaken by the patients. A "Taiwanese Depression Questionnaire" pre-test and after-test will be undertaken by the patients. Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks. Data were analyzed using SPSS 20.0, using generalized estimating equation, GEE.
The study hypothesized that the auricular acupressure treatment would improve post-stroke depression. Therefore, participants would be more willing to receive rehabilitation program. Our study would also help to provide future references on related studies.
- Conditions
- Post-stroke Depression, Auricular Acupressure
- Being tested
- auricular acupressure
- Keywords
- stroke, heart rate variability, autonomic nerve, auricular acupressure, depression, anxiety
- Medical subject headings
- Stroke, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureOther
Auricular therapy, as defined by Oleson, refers to "a healthcare modality by stimulating the external surface of the ear to alleviate pathological conditions in other parts of the body"Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks. Receives: Other: auricular acupressure |
| Control group | No intervention | Experimental group will receive routine care for a course of four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taiwanese Depression Questionnaire
The Taiwanese Depression Questionnaire(TDQ), which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". TDQ scores range from 0 to 54. The original test authors defined three ranges for both of the scales: 0-13 (non-cases), 14-18 (doubtful cases), and 19-54(cases). The higher the score, the more severe the depression.The Taiwanese Depression Questionnaire(TDQ) had a sensitivity of 0.89 and a specificity of 0.92 .
Measured: 4 Weeks
Hospital Anxiety and Depression Scale
The reliability of the HADS was good, with Cronbach's α coefficients of 0.86 (anxiety), 0.85 (depression), and 0.91 (total scale).The HADS consists of 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression.
The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases). It is possible to calculate a HADS total score by simply summing up the anxiety and depression items.
Measured: 4 Weeks
Secondary outcomes (1)
Heart rate variability (HRV)
ANSWatch-Mini measures the following physiological parameters while sitting or lying in 6 minutes:Heart rate variability (HRV) HRV is further categorized into frequency bands, the most important of which are the low frequency (LF) and high frequency (HF) components.
LF and LF/HF ratio were interpreted as indices for sympathetic activation This means HF could be a highly informative biomarker, as it can provide insight into the functional relevance of vagal activity during stress and its role in depression.
we review relevant studies on HR, HF-HRV and consider their rele vance as markers for clinical groups in the depression-anxiety spectrum for integration to new patient stratification systems.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start14 May 2021
- Primary completion13 May 2022 (estimated)
- Study completion13 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cathay General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Principal investigator, Hsin-tung Chen, Cathay General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241782
- Sponsor's protocol ID
- CGH-P110017
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cathay General Hospital
- ClinicalTrials.gov ID
- NCT05241782
- Acronym / sponsor ID
- CGH-P110017
- Conditions
- Post-stroke Depression, Auricular Acupressure
- Keywords
- stroke, heart rate variability, autonomic nerve, auricular acupressure, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cathay General HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 14 May 2021 (actual)
- Primary completion
- 13 May 2022 (estimated)
- Study completion
- 13 Aug 2022 (estimated)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart rate variability (HRV) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. Anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. The influence of acupressure over the auricle on the HRV, anxiousness and depressive mood have yet to be verified. The investigators aimed to study the effect on auricular acupressure treatment between the different trending of HRV, anxiety and depression and their correlations.
This is a randomized control study, consisted of 70 patients with post-stroke depressive mood, from both CGH and Xizhi Cathay hospital in Taiwan. HRV analysis is performed on the first 24 hours, and on a weekly basis for a total of 6 weeks. The included depressed patients were defined by the "Hospital Anxiety and Depression Scale" and weekly will be undertaken by the patients. A "Taiwanese Depression Questionnaire" pre-test and after-test will be undertaken by the patients. Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks. Data were analyzed using SPSS 20.0, using generalized estimating equation, GEE.
The study hypothesized that the auricular acupressure treatment would improve post-stroke depression. Therefore, participants would be more willing to receive rehabilitation program. Our study would also help to provide future references on related studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: auricular acupressureExperimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks. |
| Control group | No intervention | –Experimental group will receive routine care for a course of four weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over 20 years old
- Within 24 hours of arriving at the hospital with the first symptoms of stroke
- Hemorrhagic stroke:nontraumatic hemorrhagic stroke and Intracerebral Hemorrhage score 0-1
- Infarct stroke:National Institutes of Health Stroke Scale less than 30
- Able to express themselves through oral or written communication
Key exclusion criteria (5 listed)
- Previous diagnosis of arrhythmia
- Mental illness, dementia, Alzheimer's disease, or possible complete paralysis on imaging
- Subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage
- Patients with acute myocardial infarction
- There is a wound or lesion at the ear auricular point
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auricular acupressureAuricular therapy, as defined by Oleson, refers to "a healthcare modality by stimulating the external surface of the ear to alleviate pathological conditions in other parts of the body"Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks | Other | Experimental group |
Primary outcome
Taiwanese Depression Questionnaire
Time frame: 4 Weeks
The Taiwanese Depression Questionnaire(TDQ), which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". TDQ scores range from 0 to 54. The original test authors defined three ranges for both of the scales: 0-13 (non-cases), 14-18 (doubtful cases), and 19-54(cases). The higher the score, the more severe the depression.The Taiwanese Depression Questionnaire(TDQ) had a sensitivity of 0.89 and a specificity of 0.92 .
Hospital Anxiety and Depression Scale
Time frame: 4 Weeks
The reliability of the HADS was good, with Cronbach's α coefficients of 0.86 (anxiety), 0.85 (depression), and 0.91 (total scale).The HADS consists of 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases). It is possible to calculate a HADS total score by simply summing up the anxiety and depression items.
1 secondary outcome
Heart rate variability (HRV)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Post-stroke Depression and Auricular Acupressure, run by Cathay General Hospital at 1 site in Taiwan.
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 6 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 16 Feb 2022. 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 Taiwan. 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 Chen Hsin-Tung (886-83702367, junyi0118.lai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taiwanese Depression Questionnaire (time frame: 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2022.