NCT02541747

Brief Summary

This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

July 12, 2016

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

June 20, 2015

Last Update Submit

July 9, 2016

Conditions

Shift-Work Sleep Disorder

Outcome Measures

Primary Outcomes (1)

  • brain-derived neurotrophic factor

    4 weeks

Secondary Outcomes (8)

  • Pittsburgh sleep quality index (PSQI)

    4 weeks

  • Depression score ( Zung's Self-Reported Depression Scale)

    4 weeks

  • Anxiety score (Beck Anxiety Inventory)

    4 weeks

  • Heart rate variability

    4 weeks

  • Metabolic syndrome (NCEP)

    4 weeks

  • +3 more secondary outcomes

Study Arms (2)

massage

ACTIVE COMPARATOR

massage for 30 min, once a week for 4 weeks

Behavioral: massage

control

NO INTERVENTION

Rest as control

Interventions

massageBEHAVIORAL

massage

massage

Eligibility Criteria

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

You may qualify if:

  • Shift-Work Nurses and Staff

You may not qualify if:

  • Diabetes mellitus, cardiovascular disease and psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital

Taichang, 407, Taiwan

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Interventions

Massage

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Wayne HH Sheu, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2015

First Posted

September 4, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 12, 2016

Record last verified: 2015-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)