NCT02242708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

September 15, 2014

Last Update Submit

September 15, 2014

Conditions

Shift Nurses

Outcome Measures

Primary Outcomes (1)

  • Improve sleep quality.

    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 Outcomes (2)

  • Enhance human immunity

    Change from baseline in human immunity at 3 months.

  • Improve autonomic nervous function

    Change from baseline in autonomic nervous function at 3 months.

Study Arms (2)

Normal breathing

NO INTERVENTION

The control group will do normal breathing.

Alternative nostril breathing

EXPERIMENTAL

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

Behavioral: Alternative nostril breathing

Interventions

Alternative nostril breathingBEHAVIORAL

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

Alternative nostril breathing

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shift nurses

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, Taiwan

RECRUITING

Study Officials

  • Kuender D. Yang, PhD

    Chang Bing Show Chwan Memorial Hospital

    STUDY DIRECTOR

  • Ming-Ho Lee

    Chang Bing Show Chwan Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuender D. Yang, PhD

CONTACT

886-975617006yehshuhui@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 17, 2014

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

TW(1)