Shift-Work Sleep DisorderPhase 4NCT02541747
Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
A Phase 4 study testing massage in people with Shift-Work Sleep Disorder, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder
- What is being tested?
- massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shift-Work Nurses and Staff
Who cannot join
- Diabetes mellitus, cardiovascular disease and psychological disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, 407
About this study
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.
Read the detailed description
Night shift increases physical and psychological pressure, and even affects their sleep quality. This study aims to evaluate the effects of aroma massage to sleep quality of the nurses during night shift after life-style modification and/or aroma massage. The investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators expect aroma massage would improve the sleep quality during night shift.
- Conditions
- Shift-Work Sleep Disorder
- Being tested
- massage
- Medical subject headings
- Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageBehavioural
massage
| Study group | Role | What they receive |
|---|---|---|
| massage | Active comparator | massage for 30 min, once a week for 4 weeks Receives: Behavioral: massage |
| control | No intervention | Rest as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain-derived neurotrophic factor
Measured: 4 weeks
Secondary outcomes (8)
Pittsburgh sleep quality index (PSQI)
Psychological questionnaire
Measured: 4 weeks
Depression score ( Zung's Self-Reported Depression Scale)
Psychological questionnaire- Zung's Self-Reported Depression Scale
Measured: 4 weeks
Anxiety score (Beck Anxiety Inventory)
Psychological questionnaire- Beck Anxiety Inventory
Measured: 4 weeks
Heart rate variability
Cardiopulmonary functions
Measured: 4 weeks
Metabolic syndrome (NCEP)
Third Report of the National Cholesterol Education Program (NCEP) criteria
Measured: 4 weeks
VCAM-1
Cardiovascular risk and Inflammatory markers
Measured: 4 weeks
Irisin
Cardiovascular risk and Inflammatory markers
Measured: 4 weeks
circadian rhythm
orexin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne HH Sheu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541747
- Sponsor's protocol ID
- CG14114
- Status last verified
- Sep 2015
- First submitted
- 20 Jun 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments in Stress and Quality of Sleep/Life in Night-shift Nurses and Doctors
- ClinicalTrials.gov ID
- NCT02541747
- Acronym / sponsor ID
- CG14114
- Conditions
- Shift-Work Sleep Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of aroma massage to sleep quality of the nurses and staff during night shift.
Detailed description
Night shift increases physical and psychological pressure, and even affects their sleep quality. This study aims to evaluate the effects of aroma massage to sleep quality of the nurses during night shift after life-style modification and/or aroma massage. The investigators adopt a Randomized Controlled Trial (RCT) in this study. The investigators expect aroma massage would improve the sleep quality during night shift.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| massage | Active comparator | Behavioral: massagemassage for 30 min, once a week for 4 weeks |
| control | No intervention | –Rest as control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Shift-Work Nurses and Staff
Key exclusion criteria (1 listed)
- Diabetes mellitus, cardiovascular disease and psychological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massagemassage | Behavioural | massage |
Primary outcome
brain-derived neurotrophic factor
Time frame: 4 weeks
8 secondary outcomes
Pittsburgh sleep quality index (PSQI)
Time frame: 4 weeks
Depression score ( Zung's Self-Reported Depression Scale)
Time frame: 4 weeks
Anxiety score (Beck Anxiety Inventory)
Time frame: 4 weeks
Heart rate variability
Time frame: 4 weeks
Metabolic syndrome (NCEP)
Time frame: 4 weeks
VCAM-1
Time frame: 4 weeks
Irisin
Time frame: 4 weeks
circadian rhythm
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Shift-Work Sleep Disorder
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Recruiting
Role of Sleep Reactivity in Shift Work Disorder
Shift-work Disorder
Not yet recruitingObservational study
Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses
Sleep, Fatigue
RecruitingPhase 4
Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance
Shift Work Schedule, Circadian Rhythm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne HH Sheu, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing massage in people with Shift-Work Sleep Disorder, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain-derived neurotrophic factor (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.