NCT04115332

Brief Summary

The investigators provide biofeedback training to assist the abused PW nurses to reduce WPV-related stress and achieve better resilience and mental health. The research project will assess the participants' physiological indices prior to the intervention as well as their levels of resilience and mental status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 8, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
Last Updated

October 4, 2019

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

October 1, 2019

Last Update Submit

October 2, 2019

Conditions

Keywords

psychiatric nursesworkplace violenceresiliencebiofeedback trainingphysiological indicators

Outcome Measures

Primary Outcomes (2)

  • The Center for Epidemiologic Studies Depression

    The Chinese version Center for Epidemiologic Studies Depression was developed with a Cronbach's alpha of 0\_86, and it was used as the screening measure of depressive tendency in this study. The cut-off point of the scale is of greater than or equal to 15 on the CES-D score.

    15 minutes

  • The Resilience

    The Resilience Scale was developed by Friborg et al. (2006) and the Chinese version was established by Wang and Chen with satisfactory validity and reliability. The 29-item scale measures intrapersonal and interpersonal protective resources that may facilitate an individual's adaptability to and tolerance for stress and adverse life events. The scale comprises five components, including personal strength, social competence, structured style, family cohesion, and social resources. The total scores of the RS range from 29 to 203, with higher scores indicating a higher level of resilience.

    15 minutes

Secondary Outcomes (2)

  • EEG

    5 minutes

  • Heart rate

    5 minutes

Study Arms (1)

Interventional

EXPERIMENTAL

EEG Recording The one-channel EEG sensor was recorded from Cz with linked-ear reference based on the International 10-20 system. EEG signals were recorded using BioGraph Infiniti software (Version 6.0.4, n.d.) with a band-pass between 1-30 Hz. The sample rate was 256 Hz with 60-Hz notch filters, and the electrode impedances were lower than 5 kΩ. A lead II electrocardiogram (ECG) was collected for 5 minutes at baseline using the ProComp InfinitiTM system (Thought Technology Ltd., Montreal, Canada), which was installed on a laptop. A sampling rate of 2,048/second was set in order to acquire real-time interbeat intervals.

Biological: bio-feedback training

Interventions

The aim of this study was to explore the abused PW nurses who receiving bio-feedback training as an intervention improve, and change of physiological indicators before and after intervention (3 months later), which included Respiratory Rate (RR), skin conduction (SC), heart rate variability (HRV), and resilience.

Interventional

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • abused psychiatric ward (PW) nurses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 4, 2019

Study Start

July 8, 2017

Primary Completion

October 8, 2017

Study Completion

October 8, 2017

Last Updated

October 4, 2019

Record last verified: 2017-04

Locations