The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder.

Study Overview
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Brief Summary
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Poststroke depression is seen with a frequency of up to 30%. Drug options for depression and accompanying sleep problems are limited; In addition, effective doses cannot be increased depending on the comorbidities of the patients and the side effect profiles and drug interactions of the drugs used. Acupuncture has been used in Chinese traditional medicine for more than 2000 years and there are findings that it has positive effects in post-stroke depression and anxiety disorders. The aim of this study is to examine the effectiveness and reliability of acupuncture treatment in depression and anxiety disorders developing after stroke and to reduce the need for multiple drugs and / or high-dose medication in the treatment of these complications. The hypothesis of the study: Acupuncture is an effective and reliable treatment method for depression and anxiety disorders in stroke patients.

Detailed Description
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Patients who receive inpatient stroke rehabilitation at Istanbul Physical Medicine Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, will be included in the study by the inclusion and exclusion criteria. Their informed consent will be received. Initially, clinical and demographic data of all patients will be noted. Participants who volunteered for the study will be separated into the acupuncture treatment group and the control group by simple random sampling. Both the acupuncture treatment group and the control group will be included in the conventional rehabilitation program 2 hours a day, 7 days a week, for 8 weeks. In addition the acupuncture treatment group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week. During the application, the feeling of De Qi will be taken and the application will take 20 minutes. Measurements; Hamilton Depression Rating Scales, Hamilton Anxiety Rating Scales, Pittsburg Sleep Quality Index, Barthel Index, and change in psychiatric drug use will be assessed at baseline (week 0), 4th and 8th week post-treatment. The adverse events observed during the study will be noted and the compliance of patients in each application will be questioned by visual analog scale.

Official Title
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The Effectiveness of Acupuncture Treatment for Post-Stroke Depression and Anxiety Disorder: Prospective, Randomized, Controlled Trial

Conditions
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Post-stroke Depression, Anxiety Disorders

Intervention / Treatment
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* Procedure: Acupuncture Treatment
* Other: Conventional Rehabilitation Programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 2 months maximum 6 months after stroke Volunteering for study Mini-Mental State Examination >17 Patients with Hamilton Depression Rating Scale> 7 and/or Hamilton Anxiety Rating Scale> 4 assessed by the psychiatrist Exclusion Criteria: Insomnia and depression before a stroke Aphasic patients Sleep Apnea Syndrome Psychiatric Disorders (Learning disabilities, Mental disorder, Autism) Decompensated cardiac, kidney, hepatic failure Infection on Acupuncture Points Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Intervention<br>Acupuncture Treatment Group: will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week. They also will continue to receive the conventional rehabilitation programme. | Procedure: Acupuncture Treatment<br>* Acupuncture Treatment Group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points of the hemiplegic side and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week.<br>Other: Conventional Rehabilitation Programme<br>* They will continue to receive the conventional rehabilitation programme.<br>|
| Other: No Intervention<br>Control Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made. | Other: Conventional Rehabilitation Programme<br>* They will continue to receive the conventional rehabilitation programme.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale | Assessed on 17 definitions, regarding the status of patient with a scale between 0 to 4. | 1 month | 
| Hamilton Anxiety Rating Scale | Assessed on 14 definitions, regarding the status of patient with a scale between 0 to 4. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | Assessed on 11 definitions, regarding the status of patient with a scale between 0 to 3. | 1 month | 
| Barthel Index | Assessed on 10 definitions, regarding the status of patient with a scale between 0 to 15. | 1 month | 
| Up-to-date Psychiatric Drug Use | Any change on previous drug dose or any newly prescribed drug will be noted. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, stroke, acupuncture, anxiety