The Effect of Auricular Acupressure on the Improvement of Anxiousness, Depression and Heart Rate Variability in Stroke Patients

NCT05241782 | Unknown

• 1 other identifier: CGH-P110017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Depression; Auricular Acupressure

Keywords

stroke; heart rate variability; autonomic nerve; auricular acupressure; depression; anxiety

Outcome Measures

Primary Outcomes (2)

• 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 .

  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.

  4 Weeks

Secondary Outcomes (1)

• Heart rate variability (HRV)

  4 weeks

Study Arms (2)

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.

Other: auricular acupressure

Control group

NO INTERVENTION

Experimental group will receive routine care for a course of four weeks.

Interventions

auricular acupressure OTHER

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

Experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cathay General Hospital: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

Cathay General Hospital

Taipei, 106, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Chen Hsin-Tung

CONTACT

886-83702367; junyi0118.lai@gmail.com

Wang Mei-Hua

CONTACT

886-28227101; meihua@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 16, 2022
• Study Start: May 14, 2021
• Primary Completion: May 13, 2022
• Study Completion: August 13, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

TW (1)