Sleep QualityNCT04423328
Establishment of Sleep Quality, Physical and Mental Health and Occupational Burnout Management Model for Shift Nursing Staff and Evaluation of Its Effectiveness
A study testing acupressure in people with Sleep Quality and Occupational Burnout, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Occupational Burnout
- What is being tested?
- acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jun 2020to 31 Dec 2020
- 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 22 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Nursing, Taipei Veterans General Hospital,
Taipei, 112
About this study
Official title: Assistant Head Nurse (Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan)
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.
Read the 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.
- Conditions
- Sleep Quality, Occupational Burnout
- Being tested
- acupressure
- Keywords
- Sleep disturbances, HRV monitoring watch, health status, shift rotation nurses, Occupational Burnout, acupressure
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Burnout, Professional, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureBehavioural
self-acupressure
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints. Receives: Behavioral: acupressure |
| sham acupressure | Sham comparator | Every day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints Receives: Behavioral: acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
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).
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jun 2020
- Primary completion28 Aug 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Shan Jan, master, Principal investigator, Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423328
- Sponsor's protocol ID
- 2020-03-014BC
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2260484Chang, 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
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
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Head Nurse (Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan)
- ClinicalTrials.gov ID
- NCT04423328
- Acronym / sponsor ID
- 2020-03-014BC
- Conditions
- Sleep Quality, Occupational Burnout
- Keywords
- Sleep disturbances, HRV monitoring watch, health status, shift rotation nurses, Occupational Burnout, acupressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 28 Aug 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Behavioral: acupressureEvery day before going to sleep, massage acupoints for eight consecutive weeks, followed by Shenmen→Neiguan→Hegu acupoints. |
| sham acupressure | Sham comparator | Behavioral: acupressureEvery day before going to sleep, massage acupoints for eight consecutive weeks, followed by Waiguan→Liangqiu→Tiaokou→ Chengshan acupoints |
Who may qualify
- Ages
- 22 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| acupressureself-acupressure | Behavioural | acupressure, sham acupressure |
Primary outcome
sleep quality
Time frame: 3 months
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
Time frame: 3 months
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:
Time frame: 3 months
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).
1 secondary outcome
Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 2260484Cheng 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.
- BackgroundChang, 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
- BackgroundTseng, 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
- BackgroundYeh, 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
- Individual participant dataSharing planned: No
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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.
Ming-Shan Jan, master principal investigator
Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupressure in people with Sleep Quality and Occupational Burnout, run by Taipei Veterans General Hospital, Taiwan 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 3 inclusion and 3 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 16 Jun 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423328, which also lists 4 linked publications.
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 16 Jun 2020.