- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05324865
The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia
April 11, 2022 updated by: Omer Tanriverdi, Hasan Kalyoncu University
Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired.
Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment.
For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Schizophrenia is a mental illness that progresses with delusions or hallucinations, causes changes in interpersonal communication, thoughts and behaviors, continues with recovery and repetitions, and in which the interpretation of reality is impaired.
Drug treatment alone is not sufficient in schizophrenia, and it is known that negative symptoms continue even in patients with a good response to drug treatment.
For this reason, complementary therapies, psychosocial approaches and rehabilitation in addition to drug therapy increase the effectiveness of the treatment.It is seen that the tension, the effects of stress, the state of anxiety, blood pressure, heart rate, lactic acid production, sensitivity to pain are reduced by performing relaxation exercises in a suitable environment, regularly and in accordance with the technique.
Helps you think positively Studies involving patients with schizophrenia have also proven the beneficial effect of progressive relaxation, with positive changes observed through relieving anxiety, reducing psychological stress, and increasing psychological well-being.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:• Being 18 years or older,
- Having a confirmed diagnosis of schizophrenia for at least 6 months
- Having the ability to communicate and read,
- Volunteering to participate in the research.
Exclusion Criteria:• Being closed to communication,
- Not complying with the principle of voluntarism
- Patients in acute exacerbation period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Information about the experimental group was given.
Progressive muscle relaxation (PMR) for 6 weeks to patients with schizophrenia will be heard.
At the end of 6 weeks, psychiatric evaluation and mental well-being scale will be used.
|
Progressive Muscle Relaxation PMR is a technique that provides relaxation in the whole body by voluntary and regular relaxation of large muscle groups in the human body, which is included in mind-body applications.
|
|
No Intervention: Control Group
Patient identification form, psychological evaluation form and mental health form were filled in for the control group.
At the end of 6 weeks, the psychological evaluation form and the mental well-being form were filled again without any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Individual Introductory Information Form
Time Frame: 10 minute
|
Patients' personal information (age, gender, marital status, educational status, income status, employment status) and disease information (year of disease onset, is the drug treatment sufficient, does the drug take the drug regularly, is there a regular check-up, is there any substance addiction) (cigarette, alcohol), are there any non-drug treatment methods in the fight against the disease) constitute questions.
|
10 minute
|
|
Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 15 minute
|
The scale consists of 14 positive items and has a 5-point Likert-type answer key.
High scores from the scale indicate high mental well-being.
|
15 minute
|
|
Psychiatric Rating Scale(PRS)
Time Frame: 15 minute
|
This form consists of 18 items.
The items of the scale are scored between 0-6.
It shows that the severity of the disease increases as the scoring increases.
|
15 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2022
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
April 11, 2022
First Posted (Actual)
April 12, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 11, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hasan kalyoncu University Omer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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