Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia

Study Overview
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Brief Summary
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The research topic is to explore the effectiveness of abdominal breathing on improving of sleep quality and physiological index (heart rate, respiration rate and blood pressure) among patients with insomnia. This study method adopts the research design of experimental randomized controlled trials. The persons receiving the intervention of abdominal breathing training are in the experimental group, while those who do not receive it are in the control group.

Detailed Description
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Sleep problem is very common symptom problems, so often rely on sedative-hypnotics drugs. However, long-term dependence on drugs may bring serious side effects. Therefore, the research topic is to explore the effectiveness of abdominal breathing on improving of sleep quality and physiological index (heart rate, respiration rate and blood pressure) among patients with insomnia. This study method adopts the research design of experimental randomized controlled trials. The persons receiving the intervention of abdominal breathing training are in the experimental group, while those who do not receive it are in the control group. The research is conducted with A and B groups. Group A is for those who take sedative and sleeping medicine, and Group B is for those who do not take sedative and sleeping medicine. Both groups A and B have experimental group and control group. The effectiveness assessment will use the Pittsburgh Quality Sleep Index (PSQI) and vital signs (heart rate, breathing and blood pressure). These assessments need to complete by both the experimental group and control group. This study uses the pre-test before the implementation of abdominal breathing training, and uses the post-test at week 4 and week 8 the end of abdominal breathing training. The experimental group will receive the abdominal breathing training for a total of 8 weeks. Abdominal breathing training is carry out in the sleep center of hospital (once every 1 week, and 15 minutes every time). When the persons are at home, they will receive self-training using the abdominal breathing training video (every day 10 minutes, can include every time during the day). Moreover, the persons need to complete the abdominal breathing training log. Hopefully, this study may develop that does not use drugs, but improves sleep quality and physiological index through abdominal breathing.

Official Title
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The Effect of Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Abdominal breathing training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those with a total score greater than 5 points on the Pittsburgh Sleep Product Quality Table have been diagnosed with insomnia based on the Taiwan Psychiatric Association (2014) DSM-5 Psychiatric Disorder Diagnosis and Statistics, who have agreed to participate in this study and have completed a written consent form. Exclusion Criteria: Patients with COPD

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study method adopts the research design of experimental randomized controlled trials. The persons receiving the intervention of abdominal breathing training are in the experimental group, while those who do not receive it are in the control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The effectiveness of receiving abdominal breathing training<br>Training for 8 weeks (1 time a week, 15 minutes each time). Performed one-on-one by a trainer in a sleep center. At home, you can use the abdominal breathing training video to train yourself (10 minutes a day, can be divided into 10 minutes), and you need to fill in the abdominal breathing training log. | Behavioral: Abdominal breathing training<br>* In the sleep center, it is carried out in a one-on-one manner by the trainer. At home, self-training through abdominal breathing training videos (10 minutes per day, you can accumulate up to 10 minutes in divided doses)<br>|
| No Intervention: The effectiveness of not receiving abdominal breathing training<br>The trainer does not provide abdominal breathing training, does not perform abdominal breathing exercises at home, and does not need to fill in abdominal breathing training logs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | The total items of Pittsburgh Sleep Quality Index inventory are 7. The score of each item is from 0-3. The score>5 points means the sleep quality is good. Meanwhile the score ≦5 points is poor sleep quality. | Pre-test | 
| Pittsburgh Sleep Quality Index | The total items of Pittsburgh Sleep Quality Index inventory are 7. The score of each item is from 0-3. The score>5 points means the sleep quality is good. Meanwhile the score ≦5 points is poor sleep quality. | Post-test at week 4 | 
| Pittsburgh Sleep Quality Index | The total items of Pittsburgh Sleep Quality Index inventory are 7. The score of each item is from 0-3. The score>5 points means the sleep quality is good. Meanwhile the score ≦5 points is poor sleep quality. | Post-test at week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Before the abdominal breathing record the heart rate | Pre-test | 
| Respiration rate | Before the abdominal breathing record the respiration rate | Pre-test | 
| Blood pressure | Before the abdominal breathing,record the blood pressure | Pre-test | 
| Heart rate | After abdominal breathing for 4 weeks, and than record the heart rate | Post-test at week 4 | 
| Respiration rate | After abdominal breathing for 4 weeks, and than record the respiration rate | Post-test at week 4 | 
| Blood pressure | After abdominal breathing for 4 weeks, and than record the blood pressure | Post-test at week 4 | 
| Heart rate | After abdominal breathing for 8 weeks, and than record the heart rate | Post-test at week 8 | 
| Respiration rate | After abdominal breathing for 8 weeks, and than record the respiration rate | Post-test at week 8 | 
| Blood pressure | After abdominal breathing for 8 weeks, and than record the blood pressure | Post-test at week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal breathing, quality of sleep, physiological index, effectiveness