The effect of sleep improvement program in the intensive care unit after changing to 12 hour shift.

JRCT ID: jRCT1040220075

Registered date:18/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Shift worker sleep disorder
• Date of first enrollment: 18/10/2022
• Target sample size: 65
• Study type: Interventional

Intervention(s)

<Sleep Improvement Program; iCBT- S(WB)>
The following contents are included.
-Provision of sleep improvement advice by sleep specialists and occupational physicians by referring to wearables and questionnaire answers.
(Frequency of advice delivery: daily for the first week, twice a week thereafter)
-AI-based happiness prediction results
-Graphic display of objective sleep and activity data to promote understanding of one's current situation
-Self-assessment of advice attainability
-Referral to content related to sleep education

Outcome(s)

Primary Outcome

1) Comparison of effectiveness of sleep improvement programs
Change in sleep duration = average sleep duration in week 4 - average sleep duration before test
Average pre-test sleep time: Average value from day4 to day10
Average sleep time in week 4: Average value from day32 to day38

Secondary Outcome

1) Comparison of baseline and post-intervention biometric data and questionnaire results
a) Biometric information
Percentage change (%) in activity (calories consumed, number of steps taken), subjective wellbeing (good wakefulness, happiness, vitality, sense of health, calmness), reaction time (evaluation of concentration and productivity), sleep quality and quantity (subjective evaluation, sleep duration, number of awakenings, wake duration), heart rate
Rate of change (%)=(median of week 4 - median of week 1)/median of week 1 x 100
Median of week 1: Median of day11-day17
Median of the 4th week: Median of day32-day38
b) Questionnaire
Pittsburgh Sleep Qulity Index (PSQI), Japanese version of Epworth Sleepiness Scale (JESS), Characteristic Anxiety Scale (STAI), Mental Health Questionnaire (GHQ), Japanese version of Burnout Scale, system usability score post-test, pretest and post-test Rate of change (%)
Rate of change (%) = (posttest - pretest) / pretest x 100
(2) Comparison of biometric information and questionnaire results with previous studies (three shifts)
The results of this study will be compared with those of previous studies
a) Biometric information
Percentage change (%) in activity (calories consumed, number of steps taken), subjective wellbeing (good wakefulness, happiness, vitality, sense of health, calmness), reaction time (evaluation of concentration and productivity), sleep quality and quantity (subjective evaluation, sleep duration, number of awakenings, wake duration), heart rate
Rate of change (%)=(median of week 4 - median of week 1)/median of week 1 x 100
Median of week 1: Median of day11-day17
Median of the 4th week: Median of day32-day38
b) Questionnaire
Pittsburgh Sleep Qulity Index (PSQI), Japanese version of Epworth Sleepiness Scale (JESS), Characteristic Anxiety Scale (STAI), Mental Health Questionnaire (GHQ), Japanese version of Burnout Scale, system usability score post-test, pretest and post-test Rate of change (%)
Rate of change (%) = (posttest - pretest) / pretest x100

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Nurse working at Mie University Intesnsive Care Unit.
-Work schedules of 12 hours shift.
-Pittsburgh sleep quality index equal to or more than 5.
-Has given signed concent doccumentation of participation in the study, by his/her free will.

Exclude criteria

-Has been dignosed as sleep apnea syndrome, restless leg syndrome, narcolepsy or other sleep disorders.
-Has been disgnosed as depression, panic disorder, or anxiety disorder.
-Pregnancy.
-Those at high risk of skin rash, such as history of contact dermatitis or other skin disorders.
-Those who are deemed inappropriate for inclusion by the investigators.

Related Information

• Primary Sponsor: Shimaoka Motomu