- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03908554
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses: A Randomize Controlled Trail and One-Year Follow-up
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators conducted a randomized control trail in 30 nurses admitted to their Hospital. Progressive relaxation training, posture and breath exercises and ergonomic suggestion as a WHPP was applied to the intervention group (n=15) during the five weeks. Visual Analogue Scale (VAS) was used to determine the pain, fatigue and stress levels of the nurses. Brief COPE and the Professional Quality of Life Scale, Version 4 (Pro-QoL) were used to evaluate the coping skills and quality of life. The evaluations were performed three times on all the participants as; before and after training and the one-year follow-up.
Inclusion criteria of this study were working actively and at least 40 hours working in a week. Participants who have psychiatric illnesses with or without medication, prior training or current use of relaxation therapy and participants without consent were excluded.
Eighty nurses aged between 18 and 65, working in a hospital have been informed about the study. Forty-three nurses who met the criteria and signed consent forms were included in this study. WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Working actively and at least 40 hours working in a week,
- Working as a nurse.
Exclusion Criteria:
- Have psychiatric illnesses with or without medication,
- Have prior training or current use of relaxation therapy and participants without consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intervention
The WHPP was applied to the intervention group in the workplace for two times a week for five weeks.
During the first 5 minutes of the session, breathing exercises, 20 minutes, PMR and 10 minutes, posture exercises were performed.
PMR has progressed gradually to every session.
The program is under control with a follow-up chart of what the participants do every day, and the participants were supported with various reminders (i.e., graphical leaflets on PMR techniques which also can be used as a guide while practicing at home).
|
WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
|
No Intervention: Control
Participants of the control group rested in a room for 40 minutes and were told that they could read every session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Professional Quality of Life Scale, Version 4 (ProQoL):
Time Frame: Change from Baseline to after 5 weeks and at a year
|
ProQoL (has 30 items) measures the positive and negative effects experienced by those who choose to help people with pain and trauma (Stamm, 2009).
It is made up of three subscales: Compassion Satisfaction (CS), Burnout, Secondary Traumatic Stress (STS).
The ProQOL prompts participants to rate the frequency of the experience of certain feelings in their workplace with the clients in the last 30 days.
Items are rated on a 6-point scale (from 0: never to 5:very often).
|
Change from Baseline to after 5 weeks and at a year
|
Coping Orientation to Problems Experienced (Brief COPE):
Time Frame: Change from Baseline to after 5 weeks and at a year
|
Brief COPE (has 28 items) measures 14 different coping strategies and they targets three categories: problem-focused (active coping, planning, use of instrumental support), emotion-focused (use of emotional support, positive reframing, acceptance, religion, humor), and dysfunctional coping (venting, denial, substance use, behavioral disengagement, self-distraction, self-blame. Each statement is graded on a four-point Likert scale: 1 = very seldom, 2 = fairly seldom, 3 = fairly often, 4 = very often. |
Change from Baseline to after 5 weeks and at a year
|
Visual Analog Scale (VAS)
Time Frame: Change from Baseline to after 5 weeks and at a year
|
VAS is a tool developed by Price et al., aims to measure subjective experience such as pain (Hasson & Arnetz, 2005).
Also, in the literature, VAS was reported to have a better response(i.e., ability to detect clinically significant change) compared to the Likert scale and might also be more reliable and valid (Vickers, 1999).
The scale was applied by marking a point on the vertical or horizontal line that corresponds to the severity of the pain/fatigue/stress felt by the person, with a length of 10 cm and two different names (0 = no pain, 10 = most severe pain).
The distance between the marking point and the lowest tip of the line was measured in centimeters, and the numerical value found was indicative of the pain/fatigue/stress intensity of the person
|
Change from Baseline to after 5 weeks and at a year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 431-1271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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