Sleep QualityNCT03627221
Survey of Students' Sleep Related Outcomes and Sleep Management Network for Sleep
A study testing music listening and social network in people with Sleep Quality, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- music listening and social network
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2018to Jul 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- poor sleep quality (PSQI > 5)
Who cannot join
- pregnancy
- currently receiving stress management programs
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu Chi University
Hualien City, 97004
Hui-Ling Lai, PhD, 011886970332631, snowjade@gms.tcu.edu.tw
About this study
Official title: The Effects of Combined Music Care With Sleep Management Network on Sleep Quality, Sleep Knowledge, and Sleep Hygiene in Nursing Students
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.
Read the 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.
- Conditions
- Sleep Quality
- Being tested
- music listening and social network
- Keywords
- social network, nursing students, sleep, music care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listening and social networkBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months (intervention will last for 12 weeks)
Secondary outcomes (4)
sleep knowledge
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.
Measured: 18 months (intervention will last for 12 weeks)
sleep hygiene
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.
Measured: 18 months (intervention will last for 12 weeks)
daytime fatigue
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.
Measured: 18 months (intervention will last for 12 weeks)
daytime sleepiness
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.
Measured: 18 months (intervention will last for 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start2 Oct 2018
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Ling Lai, Buddhist Tzu Chi General Hospital
- Investigators
- Hui-Ling Lai, PhD, Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627221
- Sponsor's protocol ID
- IRB106-183-A
- Status last verified
- Jul 2020
- First submitted
- 7 Aug 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combined Music Care With Sleep Management Network on Sleep Quality, Sleep Knowledge, and Sleep Hygiene in Nursing Students
- ClinicalTrials.gov ID
- NCT03627221
- Acronym / sponsor ID
- IRB106-183-A
- Conditions
- Sleep Quality
- Keywords
- social network, nursing students, sleep, music care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Aug 2018 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| music listening and social network | Experimental | Behavioral: music listening and social networkThe 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). |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- poor sleep quality (PSQI > 5)
Key exclusion criteria (2 listed)
- pregnancy
- currently receiving stress management programs
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 |
|---|---|---|
| music listening and social networkThe 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. | Behavioural | music listening and social network |
Primary outcome
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.
4 secondary outcomes
sleep knowledge
Time frame: 18 months (intervention will last for 12 weeks)
sleep hygiene
Time frame: 18 months (intervention will last for 12 weeks)
daytime fatigue
Time frame: 18 months (intervention will last for 12 weeks)
daytime sleepiness
Time frame: 18 months (intervention will last for 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Sleep Quality
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Not yet recruitingObservational study
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
Encephalopathy
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
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.
Hui-Ling Lai, PhD principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music listening and social network in people with Sleep Quality, run by Buddhist Tzu Chi 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 2 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: status not confirmed, as of the sponsor's last update on 10 Jul 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Ling Lai, PhD (011-886-970332631, snowjade@mail.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: 18 months (intervention will last for 12 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 10 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.