- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627221
Survey of Students' Sleep Related Outcomes and Sleep Management Network for Sleep
The Effects of Combined Music Care With Sleep Management Network on Sleep Quality, Sleep Knowledge, and Sleep Hygiene in Nursing Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hui-Ling Lai, PhD
- Phone Number: 011-886-970332631
- Email: snowjade@mail.tcu.edu.tw
Study Locations
-
-
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Hualien City, Taiwan, 97004
- Recruiting
- Tzu Chi University
-
Contact:
- Hui-Ling Lai, PhD
- Phone Number: 011886970332631
- Email: snowjade@gms.tcu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
poor sleep quality (PSQI > 5)
Exclusion Criteria:
- pregnancy
- currently receiving stress management programs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: music listening and social network
The intervention group will receive music listening at sleep time and will be invited to join a social network for 12 weeks.
But their sleep quality , sleep knowledge, sleep hygiene, daytime fatigue, and daytime sleepy will be collected for 12 months (at baseline, 3 month, 6 month, and the 12th month).
|
The 12-week combination of music care and social network program consists of three parts: sleep related variables assessment and monitoring, sleep management education and outcome evaluation.
Participants in the intervention group will receive weekly online (social network) education and music listening interventions for 12 weeks provided by the PI.
|
No Intervention: Control group
The control group will not receive music listening at sleep time and will not be invited to join a social network for 12 weeks.
But their sleep quality, sleep knowledge, sleep hygiene, daytime fatigue, and daytime sleepy will be collected for 12 months (at baseline, 3 month, 6 month, and the 12th month).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep quality
Time Frame: 18 months (intervention will last for 12 weeks)
|
participants' subjective sleep quality will be measured by using the Pittsburgh Sleep Quality Index (PSQI).
The PSQI has 19 items, most with a 4-point, Likert-type response scale.
The total score of the 19 items is ranged between 0-21.
The higher scores (greater than 5) indicate the participants have poorer sleep quality.
|
18 months (intervention will last for 12 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep knowledge
Time Frame: 18 months (intervention will last for 12 weeks)
|
The investigators developed questionnaire of sleep knowledge is a 10-15 questions regarding sleep-related knowledge.
Each item offered three response options: yes, no, or unsure.
One point was assigned for a correct response, and zero was assigned for incorrect or "unsure" responses.
The maximum score was 10-15 points.
The total score was treated as a global indicator of the levels of the participants' sleep knowledge.
A higher score indicated that they were more knowledgeable about sleep.
|
18 months (intervention will last for 12 weeks)
|
sleep hygiene
Time Frame: 18 months (intervention will last for 12 weeks)
|
Sleep Hygiene Index (SHI) will be used to measure participants' practice of sleep hygiene behaviors.
The SHI is a 13-item self-report rated on a five-point scale ranging from 0 (never) to 4 (always).
Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.
|
18 months (intervention will last for 12 weeks)
|
daytime fatigue
Time Frame: 18 months (intervention will last for 12 weeks)
|
Daytime fatigue will be measured by using a 7-item scale, Flinders Fatigue Scale. Six items are presented in Likert format, with responses ranging from 0 (not at all) to 4 (extremely). Item 5 measures the time of day when fatigue is experienced and uses a multiple-item checklist. Total fatigue is calculated as the sum of all individual items. Total fatigue scores range from 0 to 31, with higher scores indicating greater fatigue. |
18 months (intervention will last for 12 weeks)
|
daytime sleepiness
Time Frame: 18 months (intervention will last for 12 weeks)
|
The Epworth Sleepiness Scale (ESS), a self-report 8-item questionnaire will be used to measure daytime sleepiness.
The ESS is a four-point rating scale.
Response categories range from "0 = would never doze," "1 = slight chance of dozing," "2 = moderate chance of dozing," "3 = high chance of dozing."
Ratings are added over the eight items for a total score.
The range of possible scores is from 0 to 24 points.
|
18 months (intervention will last for 12 weeks)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Hui-Ling Lai, PhD, Tzu Chi University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB106-183-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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