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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04115332
Other study ID # KMUHIRB-E(II)-20170101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 8, 2017
Est. completion date October 8, 2017

Study information

Verified date April 2017
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This was a quasi-experimental study, structured questionnaires of Resilience Score, The Center for Epidemiologic Studies Depression (CES-D) and Occupational Stress Indicator-2 were used in this study before and three months after intervention. A total of 112 abused psychiatric nurses were randomly assigned to 3 groups. The biofeedback group (n=40) received the biofeedback training and the self-training group received video relaxation training by Line (n=44). The control group (n=28) did not receive any intervention.

Biofeedback training is an effective intervention to enhance abused PW nurses' resilience and lower their depressive symptoms. Video relaxation self-training is also an effective way to strengthen abused psychiatric nurses' resilience.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date October 8, 2017
Est. primary completion date October 8, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- abused psychiatric ward (PW) nurses

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms

  • Psychiatric Nurses, Workplace Violence, Biofeedback Training, and Resilience

Intervention

Biological:
bio-feedback training
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.

Locations

Country Name City State
Taiwan Kaohsiung Medical University Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 EEG 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. 5 minutes
Secondary Heart rate 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. 5 minutes