Clinical trial NCT05241782: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Depression
Auricular Acupressure
Keywords: stroke
heart rate variability
autonomic nerve
auricular acupressure
depression
anxiety
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2022-02-16
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. over 20 years old
2. Within 24 hours of arriving at the hospital with the first symptoms of stroke
3. Hemorrhagic stroke:nontraumatic hemorrhagic stroke and Intracerebral Hemorrhage score 0-1
4. Infarct stroke:National Institutes of Health Stroke Scale less than 30
5. Able to express themselves through oral or written communication
6. Hospital Anxiety and Depression Scale Score equal to or greater than 11

Exclusion Criteria:

1. Previous diagnosis of arrhythmia
2. Mental illness, dementia, Alzheimer's disease, or possible complete paralysis on imaging
3. Subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage
4. Patients with acute myocardial infarction
5. There is a wound or lesion at the ear auricular point

Primary outcomes:
measure: Taiwanese Depression Questionnaire
timeFrame: 4 Weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 4 Weeks
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
References: