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The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses

Primary Purpose

Nurses, Work-Related Stress Disorder, Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WORKPLACE HEALTH PROMOTION PROGRAM
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nurses focused on measuring coping skill, quality of life, pain, fatigue, Workplace Health Promotion Program

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention

    Control

    Arm Description

    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).

    Participants of the control group rested in a room for 40 minutes and were told that they could read every session.

    Outcomes

    Primary Outcome Measures

    The Professional Quality of Life Scale, Version 4 (ProQoL):
    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).
    Coping Orientation to Problems Experienced (Brief COPE):
    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.
    Visual Analog Scale (VAS)
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2019
    Last Updated
    April 15, 2019
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03908554
    Brief Title
    The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses
    Official Title
    The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses: A Randomize Controlled Trail and One-Year Follow-up
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 3, 2015 (Actual)
    Primary Completion Date
    September 3, 2018 (Actual)
    Study Completion Date
    December 10, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pain, fatigue, and stress lead to decrease on their work performance with biopsychosocial functioning disorders on nurses. This study was conducted to examine the effects of the "Workplace Health Promotion Program" (WHPP) on pain, fatigue, stress, professional quality of life (Pro-QoL) and coping skills for nurses.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nurses, Work-Related Stress Disorder, Pain, Fatigue
    Keywords
    coping skill, quality of life, pain, fatigue, Workplace Health Promotion Program

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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). Participants of the control group rested in a room for 40 minutes and were told that they could read every session.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants of the control group rested in a room for 40 minutes and were told that they could read every session.
    Intervention Type
    Other
    Intervention Name(s)
    WORKPLACE HEALTH PROMOTION PROGRAM
    Intervention Description
    WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
    Primary Outcome Measure Information:
    Title
    The Professional Quality of Life Scale, Version 4 (ProQoL):
    Description
    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).
    Time Frame
    Change from Baseline to after 5 weeks and at a year
    Title
    Coping Orientation to Problems Experienced (Brief COPE):
    Description
    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.
    Time Frame
    Change from Baseline to after 5 weeks and at a year
    Title
    Visual Analog Scale (VAS)
    Description
    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
    Time Frame
    Change from Baseline to after 5 weeks and at a year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Nurses
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses

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