Clinical trial NCT05581355: Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia
Official title: The Effect of Abdominal Breathing on Improving of Sleep Quality and Physiological Index Among Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: abdominal breathing
quality of sleep
physiological index
effectiveness
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre-test
measure: Pittsburgh Sleep Quality Index
timeFrame: Post-test at week 4
measure: Pittsburgh Sleep Quality Index
timeFrame: Post-test at week 8
Secondary outcomes:
measure: Heart rate
timeFrame: Pre-test
measure: Respiration rate
timeFrame: Pre-test
measure: Blood pressure
timeFrame: Pre-test
measure: Heart rate
timeFrame: Post-test at week 4
measure: Respiration rate
timeFrame: Post-test at week 4
measure: Blood pressure
timeFrame: Post-test at week 4
measure: Heart rate
timeFrame: Post-test at week 8
measure: Respiration rate
timeFrame: Post-test at week 8
measure: Blood pressure
timeFrame: Post-test at week 8
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Xuan-Yi Huang
state: Peitou
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Xuan-Yi Huang, DNSc
role: PRINCIPAL_INVESTIGATOR
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