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Completed

NCT Number: NCT07150507

The Effectiveness of Breathing Therapy 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.

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Key information

Conditions

Breathing Therapy Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Not being open to communication and cooperation

Treatment and study plan

Session 1: Preparation Session

Other

*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 Illness

Other

*What is Schizophrenia? *What are its Symptoms? *What Does Treatment Include?

Session 3: Treatment Evaluation

Other

*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: Communication

Other

*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: Relaxation

Other

Practicing the relaxation CD with patients

Session 8: Evaluation

Other

*Reinforcing what has been learned. *Evaluating the program. *Obtaining feedback

Primary outcomes

  1. 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.

Secondary outcomes

  1. DSM-5 Sleep Disorder Scale

    Time frame: up to 1 day

    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.

Other outcomes

  1. Brief Fatigue Inventory

    Time frame: up to 1 day

    Developed by Mendoza and colleagues at the M.D. Anderson Cancer Center in 1999, the scale consists of 10 questions. The form assesses general fatigue levels (fatigue felt at the time of the interview, general fatigue experienced within the last 24 hours, and the worst fatigue level experienced within the last 24 hours) and the degree to which daily activities (general activity, mood, walking ability, life outside the home, communication with others, and joy of life) have been affected by fatigue in the last 24 hours. The arithmetic mean of the scores given for these first three questions is calculated to obtain each individual's fatigue score. The Cronbach's α value for the original scale, developed by Mendoza and colleagues (1999), was found to be 0.96.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Effectiveness of Breathing Therapy in Reducing Sleep and Fatigue Symptoms in Patients With Schizophrenia

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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