Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
Primary Purpose
Schizophrenia, Schizoaffective
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring acupuncture, schizophrenia, insomnia
Eligibility Criteria
Inclusion Criteria:
- schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
- capability to sign inform consent.
Exclusion Criteria:
- unstable physical illness
- drug or alchohol abuse or dependence
Sites / Locations
- Haemek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acupuncture needles
Arm Description
Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD.
Outcomes
Primary Outcome Measures
sleep efficiency
Secondary Outcome Measures
anxiety and depression levels
Full Information
NCT ID
NCT00780884
First Posted
October 26, 2008
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00780884
Brief Title
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
Official Title
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Insomnia, a common feature of schizophrenia, has serious consequences for daytime functioning and quality of life. Although insomnia is most often treated with medication, a growing number of studies have demonstrated the efficiency of a variety of relaxation techniques, cognitive behavioral therapies and alternative medicine procedures. Acupuncture is among the oldest healing practices in the world. Part of traditional Chinese medicine, acupuncture aims to restore and maintain health through the stimulation of specific points on the body. Previous studies have demonstrated that acupuncture has a positive influence on a number of diseases and disorders, among them Depression, Chronic Pain and Sleep Disorders. Hence, the aim of the present study is to examine the effects of acupuncture as a treatment for insomnia in schizophrenic patients.The study begins with a 7-day, running-in, no-treatment period, followes by an 8-week experimental period. During the experimental period, subjects receive acupuncture treatments twice a week. During the first week of the study (no-treatment period) and the last week of the experimental period, subjects' sleep is monitored with a wrist actigraph, and subjects complete a wide spectrum of questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective
Keywords
acupuncture, schizophrenia, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture needles
Arm Type
Experimental
Arm Description
Acupuncture needles named acuzone needles. The acuzone needles are sterile and single use, manufactured by DONG BANG MEDICAL CO.,LTD.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
16 sessions of acupuncture treatment, twice a week.
Primary Outcome Measure Information:
Title
sleep efficiency
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
anxiety and depression levels
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
schizophrenia or schizoaffective disorder - diagnosed according DSM-4.
capability to sign inform consent.
Exclusion Criteria:
unstable physical illness
drug or alchohol abuse or dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Kremer, MD
Organizational Affiliation
Haemek Mediacl Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Influence of Acupuncture on Emotional Measures and Quality of Sleep Among Schizophrenia Patients
We'll reach out to this number within 24 hrs