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Trial record 16 of 8465 for:    complementary OR alternative OR integrative AND coping

The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing

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ClinicalTrials.gov Identifier: NCT02242708
Recruitment Status : Unknown
Verified September 2014 by Ming-Ho Lee, Chang Bing Show Chwan Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Ming-Ho Lee, Chang Bing Show Chwan Memorial Hospital

Brief Summary:
The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative nostril breathing to improve life quality, autonomic nervous system and immune status.

Condition or disease Intervention/treatment Phase
Shift Nurses Behavioral: Alternative nostril breathing Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing
Study Start Date : October 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

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.
Behavioral: Alternative nostril breathing
The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Shift nurses

Exclusion Criteria:

  • Upper respiratory tract infection such as nasal congestion, runny nose, coughing, wheezing, nosebleeds, fever and other symptoms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242708


Contacts
Contact: Kuender D. Yang, PhD 886-975617006 yehshuhui@gmail.com

Locations
Taiwan
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital Recruiting
Changhua County, Taiwan
Contact: Kuender D. Yang, PhD    886-975617006    yangkd.yeh@hotmail.com   
Sponsors and Collaborators
Chang Bing Show Chwan Memorial Hospital
Investigators
Study Director: Kuender D. Yang, PhD Chang Bing Show Chwan Memorial Hospital
Principal Investigator: Ming-Ho Lee Chang Bing Show Chwan Memorial Hospital

Responsible Party: Ming-Ho Lee, MD., Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT02242708     History of Changes
Other Study ID Numbers: 1010807
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014