Survey of Students' Sleep Related Outcomes and Sleep Management Network for Sleep
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|ClinicalTrials.gov Identifier: NCT03627221|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Quality||Behavioral: music listening and social network||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The intervention is social networking and music listening. The outcome variables are sleep quality, sleep knowledge, and sleep hygiene. The control variables are participants' demographic data.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A licensed sleep technician, blinded to group assignment, visually analyzed sleep polygraphs by applying standard procedures.|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effects of Combined Music Care With Sleep Management Network on Sleep Quality, Sleep Knowledge, and Sleep Hygiene in Nursing Students|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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).
Behavioral: music listening and social network
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).
- 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.
- 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.
- 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.
- 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.
- 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.
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): NCT03627221
|Contact: Hui-Ling Lai, PhDfirstname.lastname@example.org|
|Principal Investigator:||Hui-Ling Lai, PhD||Tzu Chi University|