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临床试验/NCT07150507
NCT07150507已完成不适用

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

Ataturk University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Personal Information Form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •Not being open to communication and cooperation

研究组 & 干预措施

Session 4: *What is anger?

Experimental

*What are the symptoms of anger? *What are the methods for coping with anger?

干预措施: Session 4: What is anger? (Other)

Session 5: Communication *What is communication?

Experimental

*The importance of communication. *Fundamentals of communication, self-language practice *Ways to prevent communication difficulties.

干预措施: Session 5: Communication (Other)

Session 6: What is relaxation?

Experimental

What is progressive relaxation. Relaxation CD introduction

干预措施: Session 6: What is relaxation? (Other)

Session 7: Relaxation

Experimental

Performing the relaxation CD with patients

干预措施: Session 7: Relaxation (Other)

Session 8: Evaluation

Experimental

*Reinforcement of what has been learned. *Evaluation of the program. *Receiving feedback

干预措施: Session 8: Evaluation (Other)

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

干预措施: Session 1: Preparation Session (Other)

Session 2: Recognizing the Illness

Experimental

*What is schizophrenia? *What are its symptoms? *What does treatment involve?

干预措施: Session 2: Recognizing the Illness (Other)

Session 3: Evaluating Treatment

Experimental

*Considerations regarding medication use *Side effects of medication use *Exacerbations in schizophrenia *Premonitory symptoms.

干预措施: Session 3: Treatment Evaluation (Other)

结局指标

主要结局

Personal Information Form

时间窗: 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.

次要结局

  • DSM-5 Sleep Disorder Scale(up to 1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mine CENGİZ

Lecturer Physician

Ataturk University

研究点 (1)

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