Survey of Students' Sleep Related Outcomes and Sleep Management Network for Sleep

NCT03627221 | Unknown DMC

• 1 other identifier: IRB106-183-A
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality

Keywords

social network; nursing students; sleep; music care

Outcome Measures

Primary Outcomes (1)

• sleep quality

  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 Outcomes (4)

• sleep knowledge

  18 months (intervention will last for 12 weeks)

• sleep hygiene

  18 months (intervention will last for 12 weeks)

• daytime fatigue

  18 months (intervention will last for 12 weeks)

• daytime sleepiness

  18 months (intervention will last for 12 weeks)

Study Arms (2)

music listening and social network

EXPERIMENTAL

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

Control group

NO INTERVENTION

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).

Interventions

music listening and social network BEHAVIORAL

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.

music listening and social network

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• poor sleep quality (PSQI \> 5)

You may not qualify if:

• pregnancy
• currently receiving stress management programs

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Tzu Chi University

Hualien City, 97004, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hui-Ling Lai, PhD

  Tzu Chi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Ling Lai, PhD

CONTACT

011-886-970332631; snowjade@mail.tcu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A licensed sleep technician, blinded to group assignment, visually analyzed sleep polygraphs by applying standard procedures.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 13, 2018
• Study Start: October 2, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)