Breathing TherapyNCT07150507
The Effectiveness of Breathing Therapy in Patients With Schizophrenia
A study testing Session 1: Preparation Session, Session 2: Recognizing the Illness and Session 3: Treatment Evaluation in people with Breathing Therapy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of breathing therapies on sleep disturbances and fatigue in patients with schizophrenia.The study will be conducted at a CMHC in Ağrı province between May and August 2021. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breathing Therapy
- What is being tested?
- Session 1: Preparation Session, Session 2: Recognizing the Illness and Session 3: Treatment Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2022to 15 May 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being registered with a CMHC
- Being diagnosed with schizophrenia
- Being between the ages of 18 and 60
- Being willing to participate in the study
- Being open to communication and cooperation
- Being in remission
Who cannot join
- Not being open to communication and cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Nursing
Erzurum, Yakutiye
About this study
Official title: Effectiveness of Breathing Therapy in Reducing Sleep and Fatigue Symptoms in Patients With Schizophrenia
This study aimed to determine the effects of breathing therapies on sleep disturbances and fatigue in patients with schizophrenia.The study will be conducted at a CMHC in Ağrı province between May and August 2021. At the CMHC, community-based mental health services are provided to patients with severe mental disorders (schizophrenia, bipolar disorder) who are in remission as assessed by a psychiatrist. The study is planned to be conducted with patients who meet the study criteria, without using a sample selection method. Patients over the age of 18 registered with CMHC and followed with a diagnosis of schizophrenia were contacted by phone and invited to CMHC. The study was conducted with patients who met the inclusion criteria and agreed to participate. Data will be collected using the Descriptive Characteristics Form, the DSM-5 Sleep Disorder Scale, and the Brief Fatigue Inventory. The experimental group received eight sessions of respiratory therapy.The control group received no intervention. The study sample size was calculated using the GPower computer program. A power analysis performed at α=0.05 revealed an effect size of 150.153 (d=0.8), providing 90% power. Therefore, it was calculated that a minimum of 68 patients should be included in the sample.
Read the detailed description
Study data were collected by the researcher through face-to-face interviews. The study included individuals diagnosed with schizophrenia who met the inclusion criteria (registration in a CMHC, having a diagnosis of schizophrenia, willingness to participate in the study, and openness to communication and collaboration). Pre-test measurement instruments were administered to the participants. The experimental group received eight sessions of respiratory therapy. The control group received no intervention. Post-test data were collected following the training sessions.
- Conditions
- Breathing Therapy
- Being tested
- Session 1: Preparation Session, Session 2: Recognizing the Illness, Session 3: Treatment Evaluation, Session 4: What is anger?, Session 5: Communication
- Keywords
- Breathing Therapy, Schizophrenia patients, Sleep, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session 1: Preparation SessionOther
*Meeting Patients *Introducing the Content of Psychoeducation *Emphasizing the Importance of Regular and Timely Attendance at Training *Determining Training Dates *Sharing Individuals' Experiences and Expectations
Session 2: Recognizing the IllnessOther
*What is Schizophrenia? *What are its Symptoms? *What Does Treatment Include?
Session 3: Treatment EvaluationOther
*Things to Consider When Using Medication *Side Effects of Medication *Exacerbation of Schizophrenia *Precursor Symptoms.
Session 4: What is anger?Other
*What are the symptoms of anger? *What are the methods for coping with anger?
Session 5: CommunicationOther
*What is communication? *The importance of communication. *Fundamentals of communication, working on "I" language. *Ways to prevent communication difficulties.
Session 6: What is relaxation?Other
What is progressive relaxation? Introducing a relaxation CD
Session 7: RelaxationOther
Practicing the relaxation CD with patients
Session 8: EvaluationOther
*Reinforcing what has been learned. *Evaluating the program. *Obtaining feedback
| Study group | Role | What they receive |
|---|---|---|
| Session 1: Preparatory Session | Experimental | *Meeting the patients *Introducing the content of psychoeducation *Emphasizing the importance of regular and timely attendance at training *Determining training dates *Sharing individuals' experiences and expectations Receives: Other: Session 1: Preparation Session |
| Session 2: Recognizing the Illness | Experimental | *What is schizophrenia? *What are its symptoms? *What does treatment involve? Receives: Other: Session 2: Recognizing the Illness |
| Session 3: Evaluating Treatment | Experimental | *Considerations regarding medication use *Side effects of medication use *Exacerbations in schizophrenia *Premonitory symptoms. Receives: Other: Session 3: Treatment Evaluation |
| Session 4: *What is anger? | Experimental | *What are the symptoms of anger? *What are the methods for coping with anger? Receives: Other: Session 4: What is anger? |
| Session 5: Communication *What is communication? | Experimental | *The importance of communication. *Fundamentals of communication, self-language practice *Ways to prevent communication difficulties. Receives: Other: Session 5: Communication |
| Session 6: What is relaxation? | Experimental | What is progressive relaxation. Relaxation CD introduction Receives: Other: Session 6: What is relaxation? |
| Session 7: Relaxation | Experimental | Performing the relaxation CD with patients Receives: Other: Session 7: Relaxation |
| Session 8: Evaluation | Experimental | *Reinforcement of what has been learned. *Evaluation of the program. *Receiving feedback Receives: Other: Session 8: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
It consists of a total of 8 questions (age, gender, marital status, education level, duration of illness, income status, family history of mental illness and employment status) created by the researcher in the light of literature and includes the sociodemographic characteristics of the patients.
Measured: up to 1 day
Secondary outcomes (1)
DSM-5 Sleep Disorder Scale
The DSM-5 Sleep Disorder Adult Scale Short Form is an eight-item scale that assesses sleep disturbances in individuals aged 18 and older. The scale is designed to be completed by the individual before a clinician's consultation. Each item asks the patient (or an informed person) to rate the severity of their sleep disturbance over the past seven days. The scale's validity and reliability in Turkish were conducted by Yüzeren et al. in 2017.
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start29 Apr 2022
- Primary completion15 Nov 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing TherapyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine CENGİZ, Ataturk University
- Investigators
- Mine Cengiz lecturer doctor, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150507
- Sponsor's protocol ID
- MCENGİZ6
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Breathing Therapy in Reducing Sleep and Fatigue Symptoms in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07150507
- Acronym / sponsor ID
- MCENGİZ6
- Conditions
- Breathing Therapy
- Keywords
- Breathing Therapy, Schizophrenia patients, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 2 Sep 2025 (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.
This study aimed to determine the effects of breathing therapies on sleep disturbances and fatigue in patients with schizophrenia.The study will be conducted at a CMHC in Ağrı province between May and August 2021. At the CMHC, community-based mental health services are provided to patients with severe mental disorders (schizophrenia, bipolar disorder) who are in remission as assessed by a psychiatrist. The study is planned to be conducted with patients who meet the study criteria, without using a sample selection method. Patients over the age of 18 registered with CMHC and followed with a diagnosis of schizophrenia were contacted by phone and invited to CMHC. The study was conducted with patients who met the inclusion criteria and agreed to participate. Data will be collected using the Descriptive Characteristics Form, the DSM-5 Sleep Disorder Scale, and the Brief Fatigue Inventory. The experimental group received eight sessions of respiratory therapy.The control group received no intervention. The study sample size was calculated using the GPower computer program. A power analysis performed at α=0.05 revealed an effect size of 150.153 (d=0.8), providing 90% power. Therefore, it was calculated that a minimum of 68 patients should be included in the sample.
Detailed description
Study data were collected by the researcher through face-to-face interviews. The study included individuals diagnosed with schizophrenia who met the inclusion criteria (registration in a CMHC, having a diagnosis of schizophrenia, willingness to participate in the study, and openness to communication and collaboration). Pre-test measurement instruments were administered to the participants. The experimental group received eight sessions of respiratory therapy. The control group received no intervention. Post-test data were collected following the training sessions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Session 1: Preparatory Session | Experimental | Other: Session 1: Preparation Session*Meeting the patients *Introducing the content of psychoeducation *Emphasizing the importance of regular and timely attendance at training *Determining training dates *Sharing individuals' experiences and expectations |
| Session 2: Recognizing the Illness | Experimental | Other: Session 2: Recognizing the Illness*What is schizophrenia? *What are its symptoms? *What does treatment involve? |
| Session 3: Evaluating Treatment | Experimental | Other: Session 3: Treatment Evaluation*Considerations regarding medication use *Side effects of medication use *Exacerbations in schizophrenia *Premonitory symptoms. |
| Session 4: *What is anger? | Experimental | Other: Session 4: What is anger?*What are the symptoms of anger? *What are the methods for coping with anger? |
| Session 5: Communication *What is communication? | Experimental | Other: Session 5: Communication*The importance of communication. *Fundamentals of communication, self-language practice *Ways to prevent communication difficulties. |
| Session 6: What is relaxation? | Experimental | Other: Session 6: What is relaxation?What is progressive relaxation. Relaxation CD introduction |
| Session 7: Relaxation | Experimental | Other: Session 7: RelaxationPerforming the relaxation CD with patients |
| Session 8: Evaluation | Experimental | Other: Session 8: Evaluation*Reinforcement of what has been learned. *Evaluation of the program. *Receiving feedback |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being registered with a CMHC
- Being diagnosed with schizophrenia
- Being between the ages of 18 and 60
- Being willing to participate in the study
- Being open to communication and cooperation
Key exclusion criteria (1 listed)
- Not being open to communication and cooperation
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 |
|---|---|---|
| Session 1: Preparation Session*Meeting Patients *Introducing the Content of Psychoeducation *Emphasizing the Importance of Regular and Timely Attendance at Training *Determining Training Dates *Sharing Individuals' Experiences and Expectations | Other | Session 1: Preparatory Session |
| Session 2: Recognizing the Illness*What is Schizophrenia? *What are its Symptoms? *What Does Treatment Include? | Other | Session 2: Recognizing the Illness |
| Session 3: Treatment Evaluation*Things to Consider When Using Medication *Side Effects of Medication *Exacerbation of Schizophrenia *Precursor Symptoms. | Other | Session 3: Evaluating Treatment |
| Session 4: What is anger?*What are the symptoms of anger? *What are the methods for coping with anger? | Other | Session 4: *What is anger? |
| Session 5: Communication*What is communication? *The importance of communication. *Fundamentals of communication, working on "I" language. *Ways to prevent communication difficulties. | Other | Session 5: Communication *What is communication? |
| Session 6: What is relaxation?What is progressive relaxation? Introducing a relaxation CD | Other | Session 6: What is relaxation? |
| Session 7: RelaxationPracticing the relaxation CD with patients | Other | Session 7: Relaxation |
| Session 8: Evaluation*Reinforcing what has been learned. *Evaluating the program. *Obtaining feedback | Other | Session 8: Evaluation |
Primary outcome
Personal Information Form
Time frame: up to 1 day
It consists of a total of 8 questions (age, gender, marital status, education level, duration of illness, income status, family history of mental illness and employment status) created by the researcher in the light of literature and includes the sociodemographic characteristics of the patients.
1 secondary outcome
DSM-5 Sleep Disorder Scale
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mine Cengiz lecturer doctor principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Session 1: Preparation Session, Session 2: Recognizing the Illness and Session 3: Treatment Evaluation in people with Breathing Therapy, run by Ataturk University at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Personal Information Form (time frame: up to 1 day). 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 2 Sep 2025.