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Establishment of Sleep Quality, Physical and Mental Health and Occupational Burnout Management Model for Shift Nursing Staff and Evaluation of Its Effectiveness

Primary Purpose

Sleep Quality, Occupational Burnout

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupressure
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Quality focused on measuring Sleep disturbances, HRV monitoring watch, health status, shift rotation nurses, Occupational Burnout, acupressure

Eligibility Criteria

22 Years - 63 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Shift nursing staff who have been employed in this institution for more than one year, and there have been more than two shift types in the past year. Can fill out the questionnaire and agree to participate in this research and sign the consent form.
  2. Chinese Health Questionnaire-12 > 1.5
  3. Epworth sleepiness scale > 6.5 points

Exclusion Criteria:

  1. Long-term (more than one month) taking sleeping pills such as Benzodiazepines, Stilnox, Imovane, etc.
  2. Nursing staff in the same ward as the PI.
  3. Encountered major life problems one month before the intervention, such as: falling out of love, family member's accident, personal diagnosis of illness, etc.

Sites / Locations

  • Department of Nursing, Taipei Veterans General Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

acupressure

sham acupressure

Arm Description

Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints.

Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints

Outcomes

Primary Outcome Measures

sleep quality
Epworth sleepiness scale(ESS)Epworth sleepiness Scale - Taiwan form (ESS-T): .The internal consistency of the scale Cronbach's α = .81, and then measured the reliability r = .74, p = .001. .The evaluation of the degree of drowsiness is expressed as a score of zero (never occurred) to three (almost all), with a total of 24 points. The higher the total score, the more severe the level of drowsiness. A zero score indicates the best situation.
Physical and Mental Health
Chinese Health Questionnaire-12 (CHQ-12): The reliability and validity of Cronbach'α was 0.83-0.92 (Cheng et al., 1990) CHQ-12 has 12 questions in total, two of which are positive. Ten questions of which are negative. It is a self-reported four-point scale. It is score from 0-0-1-1, with a total score of 12 points.
Chinese version of the Occupational Burnout Inventory:
The occupational burnout inventory consists of four subscales with 21 questions. All subscales have a score range of 0-100 points. The scale is measured by the respondent self-assessed the frequency of various problems in the past week. The total scale score is the sum of all subscale scores, and the higher the score, the higher the worker's feeling of burnout. The four subscales in the scale include personal burnout (5 questions), work burnout (5 questions), overwork (5 questions) and client burnout (6 questions). The Cronbach'α of the scale is above 0.84, and the scale has good construction validity and standard validity (Chang et al., 2007; Tseng, & Cheng, 2002; Yeh, Cheng, Chen, & Chiu, 2008).

Secondary Outcome Measures

Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」
The "Smart Care VIP Bracelet Watch" worn on the subject's wrist for HRV monitoring to record changes in the individual's physical activity. The contents of the record include the total daily sleep time (hours), waking time (minutes), number of waking, physical and mental index (mental stress, physical burnout) and other data for each case. To obtain the heart rate variability index directly, which represents the low frequency (LF) (%) of the sympathetic nerve activity index. High frequency power (HF) (%) representing the parasympathetic nerve activity index, and low frequency / high frequency power ratio (LF / HF) representing the sympathetic / parasympathetic balance index.

Full Information

First Posted
May 27, 2020
Last Updated
June 11, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04423328
Brief Title
Establishment of Sleep Quality, Physical and Mental Health and Occupational Burnout Management Model for Shift Nursing Staff and Evaluation of Its Effectiveness
Official Title
Assistant Head Nurse (Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 8, 2020 (Actual)
Primary Completion Date
August 28, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study was to investigate the relationship between the personal characteristics and work characteristics of shift nurses and occupational burnout, sleep quality and physical and mental health. Use " acupressure " as an intervention to compare the status of shift nurses before and after intervention and to track after interventional therapy, 1, 2, and 3 months of longitudinal results.
Detailed Description
The purpose of this study was to investigate the relationship between the personal characteristics and work characteristics of shift nurses and occupational burnout, sleep quality and physical and mental health. Use " acupressure " as an intervention to compare the status of shift nurses before and after intervention and to track after interventional therapy, 1, 2, and 3 months of longitudinal results. Use the "Smart Care VIP bracelet" to detect physical and mental conditions (psychological stress, physical fatigue) to assess the applicability of the Smart Care VIP bracelet as a "Shift Care Staff Sleep Quality, Physical and Mental Health and Occupational Burnout Management System" and evaluate effectiveness, and establishment of an effective management system. Most studies in China have shown that the use of acupressure to improve the sleep quality of nursing staff generally has its efficacy, but the lack of research at proves that acupressure is used by nursing staff to improve sleep quality and improve occupational burnout. It is expected to be from May to December 2020. The nursing staff of a medical center in Taipei will be selected for stratified sampling. The conditions for receiving the case are shift nurses who have served in the institution for more than one year. Subjective sleep is assessed using Epworth sleepiness scale. The objective part is to use the "Smart Care VIP Bracelet" to measure sleep time; Chinese version of the Chinese Health Questionnaire-12 (CHQ-12) and occupational burnout scale questionnaire as a tool for discussion. It is planned to randomly assign shift nurses to 42 acupressure groups and control group (sham), and use activity record (Smart Care VIP bracelet) to monitor and record fatigue Index and stress changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Quality, Occupational Burnout
Keywords
Sleep disturbances, HRV monitoring watch, health status, shift rotation nurses, Occupational Burnout, acupressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acupressure
Arm Type
Experimental
Arm Description
Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints.
Arm Title
sham acupressure
Arm Type
Sham Comparator
Arm Description
Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints
Intervention Type
Behavioral
Intervention Name(s)
acupressure
Intervention Description
self-acupressure
Primary Outcome Measure Information:
Title
sleep quality
Description
Epworth sleepiness scale(ESS)Epworth sleepiness Scale - Taiwan form (ESS-T): .The internal consistency of the scale Cronbach's α = .81, and then measured the reliability r = .74, p = .001. .The evaluation of the degree of drowsiness is expressed as a score of zero (never occurred) to three (almost all), with a total of 24 points. The higher the total score, the more severe the level of drowsiness. A zero score indicates the best situation.
Time Frame
3 months
Title
Physical and Mental Health
Description
Chinese Health Questionnaire-12 (CHQ-12): The reliability and validity of Cronbach'α was 0.83-0.92 (Cheng et al., 1990) CHQ-12 has 12 questions in total, two of which are positive. Ten questions of which are negative. It is a self-reported four-point scale. It is score from 0-0-1-1, with a total score of 12 points.
Time Frame
3 months
Title
Chinese version of the Occupational Burnout Inventory:
Description
The occupational burnout inventory consists of four subscales with 21 questions. All subscales have a score range of 0-100 points. The scale is measured by the respondent self-assessed the frequency of various problems in the past week. The total scale score is the sum of all subscale scores, and the higher the score, the higher the worker's feeling of burnout. The four subscales in the scale include personal burnout (5 questions), work burnout (5 questions), overwork (5 questions) and client burnout (6 questions). The Cronbach'α of the scale is above 0.84, and the scale has good construction validity and standard validity (Chang et al., 2007; Tseng, & Cheng, 2002; Yeh, Cheng, Chen, & Chiu, 2008).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」
Description
The "Smart Care VIP Bracelet Watch" worn on the subject's wrist for HRV monitoring to record changes in the individual's physical activity. The contents of the record include the total daily sleep time (hours), waking time (minutes), number of waking, physical and mental index (mental stress, physical burnout) and other data for each case. To obtain the heart rate variability index directly, which represents the low frequency (LF) (%) of the sympathetic nerve activity index. High frequency power (HF) (%) representing the parasympathetic nerve activity index, and low frequency / high frequency power ratio (LF / HF) representing the sympathetic / parasympathetic balance index.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Shift nursing staff who have been employed in this institution for more than one year, and there have been more than two shift types in the past year. Can fill out the questionnaire and agree to participate in this research and sign the consent form. Chinese Health Questionnaire-12 > 1.5 Epworth sleepiness scale > 6.5 points Exclusion Criteria: Long-term (more than one month) taking sleeping pills such as Benzodiazepines, Stilnox, Imovane, etc. Nursing staff in the same ward as the PI. Encountered major life problems one month before the intervention, such as: falling out of love, family member's accident, personal diagnosis of illness, etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shan Jan, master
Organizational Affiliation
Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nursing, Taipei Veterans General Hospital,
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2260484
Citation
Cheng TA, Wu JT, Chong MY, Williams P. Internal consistency and factor structure of the Chinese Health Questionnaire. Acta Psychiatr Scand. 1990 Oct;82(4):304-8. doi: 10.1111/j.1600-0447.1990.tb01389.x.
Results Reference
background
Citation
Chang, Y.J., Yeh, W.Y., Chen, C.W., Chen, C.J., Shih, T.S., & Cheng, Y.W. (2007). Distribution and Correlates of Burnout among Paid Employees in Taiwan. Taiwan Journal of Public Health, 26(1), 75-87. doi:10.6288/TJPH2007-26-01-09
Results Reference
background
Citation
Tseng, H.P., & Cheng, Y.W. (2002). Reliability and Validity of the Chinese Demand-Control-Support Model and Effort-Reward Imbalance Model Questionnaires: a Study Among Employees of the Microelectronic Industry. Taiwan Journal of Public Health, 21(6), 420-432. doi:10.6288/TJPH2002-21-06-05
Results Reference
background
Citation
Yeh, W.Y., Cheng, Y.W., Chen, M.J., & Chiu, W.H. (2008). Development and validation of an occupational burnout inventory. Taiwan Journal of Public Health, 27(5), 349-364. doi: 10.6288/TJPH2008-27-05-01
Results Reference
background

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Establishment of Sleep Quality, Physical and Mental Health and Occupational Burnout Management Model for Shift Nursing Staff and Evaluation of Its Effectiveness

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