Schizophrenic PsychosesNCT05324865
The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia
A study testing Progressive Muscle Relaxation in people with Schizophrenic Psychoses, run by Hasan Kalyoncu University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenic Psychoses
- What is being tested?
- Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having a confirmed diagnosis of schizophrenia for at least 6 months
- Having the ability to communicate and read,
- Volunteering to participate in the research.
Who cannot join
- Not complying with the principle of voluntarism
- Patients in acute exacerbation period
About this study
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.
Read the 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.
- Conditions
- Schizophrenic Psychoses
- Being tested
- Progressive Muscle Relaxation
- Keywords
- Schizophrenic, relaxation exercise, nursing, psychological symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Behavioral: Progressive Muscle Relaxation |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Individual Introductory Information Form
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.
Measured: 10 minute
Warwick-Edinburgh Mental Well-Being Scale
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.
Measured: 15 minute
Psychiatric Rating Scale(PRS)
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.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic PsychosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omer Tanriverdi, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324865
- Sponsor's protocol ID
- Hasan kalyoncu University Omer
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation on Psychological Symptoms and Mental Well-Being in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT05324865
- Acronym / sponsor ID
- Hasan kalyoncu University Omer
- Conditions
- Schizophrenic Psychoses
- Keywords
- Schizophrenic, relaxation exercise, nursing, psychological symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Progressive Muscle RelaxationInformation 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having a confirmed diagnosis of schizophrenia for at least 6 months
- Having the ability to communicate and read,
- Volunteering to participate in the research.
Key exclusion criteria (2 listed)
- Not complying with the principle of voluntarism
- Patients in acute exacerbation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle RelaxationProgressive 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. | Behavioural | Experimental Group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation in people with Schizophrenic Psychoses, run by Hasan Kalyoncu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual Introductory Information Form (time frame: 10 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.