- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02242708
The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise can regulate autonomic nervous function and promote relaxation. However, the mechanism for better immunity and sleep quality is not clear. We postulate that alternative nostril breathing might benefit nurses after undergoing shift work. The benefits could be due to improvement of autonomic nervous function, sleep quality, and even immune function.
The study design will include a randomization of two groups, with a control group and one experimental groups for 3 months (12 weeks). The control group will do normal breathing. The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
The study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep quality and 3) to enhance human immunity.
We anticipate to reach the primary endpoints and publish the primary results in one year.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Changhua County, Taiwan
- Recruiting
- Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
-
Contact:
- Kuender D. Yang, PhD
- Phone Number: 886-975617006
- Email: yangkd.yeh@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Shift nurses
Exclusion Criteria:
- Upper respiratory tract infection such as nasal congestion, runny nose, coughing, wheezing, nosebleeds, fever and other symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Normal breathing
The control group will do normal breathing.
|
|
|
Experimental: Alternative nostril breathing
The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
|
The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve sleep quality.
Time Frame: Change from baseline in sleep quality at 3 months.
|
Sleep quality will be assessed by pittsburg sleep quality index at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
|
Change from baseline in sleep quality at 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Enhance human immunity
Time Frame: Change from baseline in human immunity at 3 months.
|
Lymphocytes will be extracted from peripheral blood for analyses of lymphocytes subpopulation, polarization and its related cytokines.
Saliva will be collected at 3 different times: (1)baseline data: before alternate nostril breathing program ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
|
Change from baseline in human immunity at 3 months.
|
|
Improve autonomic nervous function
Time Frame: Change from baseline in autonomic nervous function at 3 months.
|
Autonomic nervous function will be assessed by biofeedback index using heart rate variability at three different times: (1)baseline data: before alternate nostril breathing practice ,(2)outcome data:6 and 12 weeks alternate nostril breathing practice, right after exercise measures post-test.
|
Change from baseline in autonomic nervous function at 3 months.
|
Collaborators and Investigators
Investigators
- Study Director: Kuender D. Yang, PhD, Chang Bing Show Chwan Memorial Hospital
- Principal Investigator: Ming-Ho Lee, Chang Bing Show Chwan Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1010807
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shift Nurses
-
Hacettepe UniversityThe Scientific and Technological Research Council of TurkeyRecruitingNurses Behaviors | Nurses | Education, Nursing StudentsTurkey (Türkiye)
-
University of GavleNot yet recruiting
-
Mansoura UniversityNot yet recruiting
-
Port Said UniversityNot yet recruiting
-
Clinica Universidad de Navarra, Universidad de...Universidad Pública de Navarra; Gobierno de NavarraUnknown
-
University of TurkuTurku University Hospital; Finnish Work Environment FundCompleted
-
King's College LondonTerminatedShift WorkUnited Kingdom
-
Abant Izzet Baysal UniversityNot yet recruitingPediatric Intensive Care NursesTurkey (Türkiye)
-
Uskudar UniversityActive, not recruitingSleep Quality | Attention | NursesTurkey
-
University of BergenCompleted
Clinical Trials on Alternative nostril breathing
-
Foundation University IslamabadRecruiting
-
Foundation University IslamabadRecruiting
-
Children's Mercy Hospital Kansas CityCompletedPregnancy Related | Blood Pressure | Hypertension in PregnancyUnited States
-
University of MinnesotaRecruitingNausea | Pregnancy EmesisUnited States
-
Foundation University IslamabadRecruiting
-
Riphah International UniversityCompleted
-
Temple UniversityCompletedOcular Hypertension
-
Sialkott College of Physical TherapyCompleted
-
Adiyaman UniversityCukurova UniversityCompleted
-
Riphah International UniversityCompleted