NursesNCT03908554
The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses
A study testing WORKPLACE HEALTH PROMOTION PROGRAM in people with Nurses and Work-Related Stress Disorder, run by Hacettepe University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nurses, Work-Related Stress Disorder, Pain
- What is being tested?
- WORKPLACE HEALTH PROMOTION PROGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 3 Apr 2015to 10 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working actively and at least 40 hours working in a week,
- Working as a nurse.
Who cannot join
- Have psychiatric illnesses with or without medication,
- Have prior training or current use of relaxation therapy and participants without consent.
About this study
Official title: The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses: A Randomize Controlled Trail and One-Year Follow-up
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.
Read the 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.
- Conditions
- Nurses, Work-Related Stress Disorder, Pain, Fatigue
- Being tested
- WORKPLACE HEALTH PROMOTION PROGRAM
- Keywords
- coping skill, quality of life, pain, fatigue, Workplace Health Promotion Program
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WORKPLACE HEALTH PROMOTION PROGRAMOther
WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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). Receives: Other: WORKPLACE HEALTH PROMOTION PROGRAM |
| Control | No intervention | Participants of the control group rested in a room for 40 minutes and were told that they could read every session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline to after 5 weeks and at a year
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.
Measured: Change from Baseline to after 5 weeks and at a year
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
Measured: Change from Baseline to after 5 weeks and at a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start3 Apr 2015
- Primary completion3 Sep 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokcen Akyurek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908554
- Sponsor's protocol ID
- 431-1271
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of "Workplace Health Promotion Program" on Pain, Fatigue, Stress in Nurses: A Randomize Controlled Trail and One-Year Follow-up
- ClinicalTrials.gov ID
- NCT03908554
- Acronym / sponsor ID
- 431-1271
- Conditions
- Nurses, Work-Related Stress Disorder, Pain, Fatigue
- Keywords
- coping skill, quality of life, pain, fatigue, Workplace Health Promotion Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Apr 2015 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: WORKPLACE HEALTH PROMOTION PROGRAMThe 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). |
| Control | No intervention | –Participants of the control group rested in a room for 40 minutes and were told that they could read every session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Working actively and at least 40 hours working in a week,
- Working as a nurse.
Key exclusion criteria (2 listed)
- Have psychiatric illnesses with or without medication,
- Have prior training or current use of relaxation therapy and participants without consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WORKPLACE HEALTH PROMOTION PROGRAMWHPP was PMR training, posture and breath exercises, and ergonomic suggestions. | Other | intervention |
Primary outcome
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).
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing WORKPLACE HEALTH PROMOTION PROGRAM in people with Nurses and Work-Related Stress Disorder, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Professional Quality of Life Scale, Version 4 (ProQoL): (time frame: Change from Baseline to after 5 weeks and at a year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.