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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
Sponsor:
Information provided by (Responsible Party):
Hui-Ling Lai, Buddhist Tzu Chi General Hospital

Brief Summary:
Several factors may cause sleep disturbance among nursing students. Sleep and its several influencing factors are both continuous dynamic process. However, research related to sleep and related issue in nursing students in a longitudinal manner is limited worldwide. Thus, the investigators intend to conduct a 3-year research divided into three phases to explore the issue. The first phase will adopt longitudinal panel study design. Nursing students from two schools will be invited to participate in the first year study, which will be about 800 people. The second phase is to classify music appreciated by the students into different music quadrants that may be effective and can be used at the third phase. The third phase is designed to explore the longitudinal effects of a 3-month social network combined with music care program on sleep quality, sleep knowledge, sleep hygiene and daytime sleepiness and fatigue. Students will be randomized into 2 groups: intervention and control groups. Participants in the intervention group will receive a 12-week intervention program. The control group will be no intervention. Growth curve modeling will be employed in this study for longitudinal analyses to identify the sleep predicted by the students' characteristics. This study will enable us to advance knowledge and research about nursing students' longitudinal patterns of sleep and the longitudinal effects of the intervention program on their sleep.

Condition or disease Intervention/treatment Phase
Sleep Quality Behavioral: music listening and social network Not Applicable

Detailed Description:
Background: Poor sleep quality affect students' learning achievement. Several factors may cause sleep disturbance among nursing students. Sleep and its several influencing factors are both continuous dynamic process. However, changes in students' sleep patterns and related characteristics over time remain unclear. Therefore, understanding the issue and examining an effective program is important to ameliorate sleep and improve learning. Integrated care program has proved to be a nursing students' health promotion intervention. However, research related to sleep and related issue in nursing students in a longitudinal manner is limited worldwide. Thus, the investigators intend to conduct a 3-year research divided into three phases to explore the issue. Objectives: The first phase will adopt longitudinal panel study design. Nursing students from two schools will be invited to participate in the first year study, which will be about 800 people.The data will be obtained from 4 waves (the interval of each wave will be 2 months) of the longitudinal survey of sleep quality of the nursing students and how the students' characteristics influence sleep. Distinct patterns of sleep over time will help to identify what characteristics of students to target for the researchers and to make evidence-based intervention for them. The second phase is to classify music appreciated by the students that may be effective and can be used at the third phase. The third phase is designed to explore the longitudinal effects of a 3-month social network combined with music care program on sleep quality, sleep knowledge, sleep hygiene and daytime sleepiness and fatigue. 100 students will be randomized into 2 groups: intervention and control groups. Participants in the intervention group will receive a 12-week intervention program. The control group will be no intervention. Data will be collected from both groups at pretests, and at different time points depending on variables after intervention completed. Statistical analysis: Growth curve modeling will be employed in this study for longitudinal analyses to identify the trajectory of sleep predicted by the students' characteristics. Descriptive analyses will be conducted using SPSS 18. Anticipated results and implications: This study will enable us to advance knowledge and research about nursing students' longitudinal patterns of sleep and the longitudinal effects of the intervention program on their sleep. If the longitudinal effects of the intervention program on their sleep are confirmed, the findings will provide evidence for educators and policy makers using evidence-based intervention to ameliorate sleep in nursing students.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

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).
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

poor sleep quality (PSQI > 5)

Exclusion Criteria:

  • pregnancy
  • currently receiving stress management programs

Information from the National Library of Medicine

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


Contacts
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Contact: Hui-Ling Lai, PhD 011-886-970332631 snowjade@mail.tcu.edu.tw

Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Principal Investigator: Hui-Ling Lai, PhD Tzu Chi University
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Responsible Party: Hui-Ling Lai, Professor, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03627221    
Other Study ID Numbers: IRB106-183-A
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Ling Lai, Buddhist Tzu Chi General Hospital:
social network
nursing students
sleep
music care