NCT04423328

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

June 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

May 27, 2020

Last Update Submit

June 11, 2020

Conditions

Keywords

Sleep disturbancesHRV monitoring watchhealth statusshift rotation nursesOccupational Burnoutacupressure

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    3 months

Secondary Outcomes (1)

  • Heart Rate Variability, HRV -「Smart Care VIP Bracelet Watch」

    3 months

Study Arms (2)

acupressure

EXPERIMENTAL

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

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

Behavioral: acupressure

Interventions

acupressureBEHAVIORAL

self-acupressure

acupressuresham acupressure

Eligibility Criteria

Age22 Years - 63 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing, Taipei Veterans General Hospital,

Taipei, 112, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 2260484BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBurnout, ProfessionalParasomnias

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ming-Shan Jan, master

    Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 9, 2020

Study Start

June 8, 2020

Primary Completion

August 28, 2020

Study Completion

December 31, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations