The Effect of Auricular Acupressure on the Improvement of Anxiousness, Depression and Heart Rate Variability in Stroke Patients
Primary Purpose
Post-stroke Depression, Auricular Acupressure
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
auricular acupressure
Sponsored by
About this trial
This is an interventional prevention trial for Post-stroke Depression focused on measuring stroke, heart rate variability, autonomic nerve, auricular acupressure, depression, anxiety
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Cathay General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks.
Experimental group will receive routine care for a course of four weeks.
Outcomes
Primary Outcome Measures
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 .
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05241782
First Posted
January 26, 2022
Last Updated
February 5, 2022
Sponsor
Cathay General Hospital
Collaborators
National Taipei University of Nursing and Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05241782
Brief Title
The Effect of Auricular Acupressure on the Improvement of Anxiousness, Depression and Heart Rate Variability in Stroke Patients
Official Title
Cathay General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
May 13, 2022 (Anticipated)
Study Completion Date
August 13, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cathay General Hospital
Collaborators
National Taipei University of Nursing and Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression, Auricular Acupressure
Keywords
stroke, heart rate variability, autonomic nerve, auricular acupressure, depression, anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Experimental group will receive routine care for a course of four weeks.
Intervention Type
Other
Intervention Name(s)
auricular acupressure
Intervention Description
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
Primary Outcome Measure Information:
Title
Taiwanese Depression Questionnaire
Description
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 .
Time Frame
4 Weeks
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
4 Weeks
Secondary Outcome Measure Information:
Title
Heart rate variability (HRV)
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Hsin-Tung
Phone
886-83702367
Email
junyi0118.lai@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Mei-Hua
Phone
886-28227101
Ext
3166
Email
meihua@ntunhs.edu.tw
Facility Information:
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Hsin-Tung, University
Phone
886-83702367
Email
junyi0118.lai@gmail.com
First Name & Middle Initial & Last Name & Degree
Wang Mei-Hua, PhD
Phone
886-28227101
Ext
3166
Email
meihua@ntunhs.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Auricular Acupressure on the Improvement of Anxiousness, Depression and Heart Rate Variability in Stroke Patients
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