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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-12-01

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.

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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.

Conditions

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Post-stroke Depression Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Intervention

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.

Group Type EXPERIMENTAL

Acupuncture Treatment

Intervention Type PROCEDURE

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.

Conventional Rehabilitation Programme

Intervention Type OTHER

They will continue to receive the conventional rehabilitation programme.

No Intervention

Control Group: will be included in the conventional rehabilitation programme and no interventional procedures will be made.

Group Type OTHER

Conventional Rehabilitation Programme

Intervention Type OTHER

They will continue to receive the conventional rehabilitation programme.

Interventions

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Acupuncture Treatment

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.

Intervention Type PROCEDURE

Conventional Rehabilitation Programme

They will continue to receive the conventional rehabilitation programme.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No