Professional Quality of LifeHSWellnessNCT05722249
Interventions to Promote Well-being of Nightshift Nursing Team Members
A study testing Mindfulness and Sleep Hygiene and Phyical activity and Sleep Hygiene in people with Professional Quality of Life, run by Children's National Research Institute at 1 site in United States.
Trial summary
Background: Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Professional Quality of Life
- What is being tested?
- Mindfulness and Sleep Hygiene and Phyical activity and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2022to 30 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants will be nurses and members of the nursing care team that work the nightshift fulltime or that rotate from the dayshift to the nightshift on a routine basis. Participants will need to be scheduled to work at least 2 weeks of the nightshift during each study period (Study Period 1, Study Period 2) to be fully eligible to participate in the study. To be fully eligible, participants must be able to complete a consent process and understand the study design and the self-report periods.
Who cannot join
- Exclusion criteria would include nurses and nursing care team members who do not rotate regularly to the nightshift or who work only the dayshift.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Background:
Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design.
Read more
Purpose and Methods:
The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
Read the detailed description
Study Purpose The purpose of this study, using a cluster cross-over randomized trial design involving inpatient units at a freestanding pediatric hospital, is to measure the impact on professional quality of life (primary endpoint), medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
Primary Objective
1.The primary objective of this study is to determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) during an 8-week study period (study period 1).
1h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).
1h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).
1h3: ProQOL scale mean scores for compassion satisfaction will not differ at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8) between the two study arms.
- h4. ProQOL mean scores for compassion fatigue will not differ between the two arms at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8). Secondary Objectives 2. Determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of the combined mindfulness intervention and physical activity intervention (Arms A and B) during a second 8-week study period (study period 2) as compared to the first study period.
- h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.
2h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.
2h3: ProQOL scale mean scores for compassion fatigue will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).
2h4. ProQOL scale mean scores for compassion satisfaction will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).
- Determine and compare the impact of the interventions by study period on role-related meaning as measured by the Role-Related Meaning Scale (RRMS) and sleep quality as measured by the PROMIS Sleep Disturbance measure and the PROMIS Sleep-Related Impairment Measure (SRI).
3h1: the RRMS mean scores will increase and PROMIS Sleep Disturbance and SRI mean scores will decrease in both study arms from baseline to Week 8, from Week 8 to Week 16, and from baseline to Week 16.
3h2: the RRMS mean scores and the PROMIS Sleep Disturbance and SRI mean scores will not differ between the two arms at baseline, Week 8 or at Week 16.
- Determine the impact of the intervention periods (Week 8, Week 16) on a patient-related indicator, Medication Administration Error as compared to the error rate at baseline.
4h1: Medication Administration Errors will not differ between the two study arms at baseline, Week 8 or at Week 16.
4h2: Medication Administration Errors will decrease within both study arms from baseline to Week8, and from Week 8 to Week 16.
General Design Description The study design is a cluster cross-over randomized trial involving 11 inpatient units at a freestanding pediatric hospital. In the randomization, the 11 units will be randomized to two study arms (Arm A - mindfulness intervention plus sleep hygiene information; Arm B - physical activity plus sleep hygiene information) during the first 8-week study period. Immediately following this study period, the units assigned to each arm will cross and receive the intervention not received in the first study period plus the ongoing access to the previous intervention. Both arms in the first study period will have education content specific to sleep hygiene connected to the existing napping option.
The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods. Interventions, such as physical activity and mindfulness, that can be done at the group level and may be more effective when done with a group, are ideal for this design (Arnup et al., 2014; Arnup et al., 2017; Parienti \& Kuss, 2007; Moerbeek, 2020; Reich et al., 2012). This design is also selected for its efficiency and reduced costs compared with a clinical trial with individuals being randomized (Taljaard et al, 2013).
- Conditions
- Professional Quality of Life
- Being tested
- Mindfulness and Sleep Hygiene, Phyical activity and Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Sleep HygieneBehavioural
Participants will experience demonstrations and explanations regarding sleep hygiene, mindfulness alerts for at work and mindfulness rest for at home.
Phyical activity and Sleep HygieneBehavioural
All enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods
| Study group | Role | What they receive |
|---|---|---|
| Arm A, Study Period 1 (Mindfulness and Sleep Hygiene): | Experimental | Immediately after the sleep hygiene content, the overview of the mindfulness intervention will be offered. All enrolled participants in Arm A, Study Period 1, will attend a 15 minute in-person "Introduction to Mindfulness" session after randomization. Receives: Behavioral: Mindfulness and Sleep Hygiene |
| Arm B, Study Period 1 (Physical Activity and Sleep Hygiene): | Active comparator | All enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods. Receives: Behavioral: Phyical activity and Sleep Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21).
The ProQOL contains two domains: Compassion Satisfaction and Compassion Fatigue. For this study, we shall administer the ProQOL-21, a revised version of the ProQOL derived from a Rasch analysis (Heritage, et al., 2018) where higher scores mean better professional quality of life.
Measured: baseline or the week before randomization, Week 8 and Week 16
Secondary outcomes (1)
change in Role-Related Meaning
Role-Related Meaning Scale (RRMS): Role-related meaning is defined as internalized, individualized awareness of personal values, and the extent to which these values are concordant with those of the role, work setting or work culture. In this study, role-related meaning will be measured using the Role-related Meaning Scale for Staff (RRMS) where higher scores mean better role meaning.
Measured: Baseline or the week before randomization, Week 8 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start7 Dec 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Professional Quality of LifeStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela Hinds, PhD, RN, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722249
- Sponsor's protocol ID
- ChildrensNRI
- Acronym
- HSWellness
- Status last verified
- Jun 2024
- First submitted
- 11 Jan 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Group summary will be provided to all upon request immediately after their publication by the study team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Promote Well-being of Nightshift Nursing Team Members
- ClinicalTrials.gov ID
- NCT05722249
- Acronym / sponsor ID
- HSWellness / ChildrensNRI
- Conditions
- Professional Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 10 Feb 2023 (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.
Background:
Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design.
Purpose and Methods:
The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
Detailed description
Study Purpose The purpose of this study, using a cluster cross-over randomized trial design involving inpatient units at a freestanding pediatric hospital, is to measure the impact on professional quality of life (primary endpoint), medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
Primary Objective
1.The primary objective of this study is to determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) during an 8-week study period (study period 1).
1h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).
1h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).
1h3: ProQOL scale mean scores for compassion satisfaction will not differ at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8) between the two study arms.
- h4. ProQOL mean scores for compassion fatigue will not differ between the two arms at baseline (the week prior to randomization to the study Arms) or at the end of the first study period (Week 8). Secondary Objectives 2. Determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of the combined mindfulness intervention and physical activity intervention (Arms A and B) during a second 8-week study period (study period 2) as compared to the first study period.
- h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.
2h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 2 from the end of the first 8-week study period (Week 8) to the end of the second study period (Week 16), and from baseline to Week 16.
2h3: ProQOL scale mean scores for compassion fatigue will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).
2h4. ProQOL scale mean scores for compassion satisfaction will not differ between the two arms at Week 8 or at the end of the second study period (Week 16).
- Determine and compare the impact of the interventions by study period on role-related meaning as measured by the Role-Related Meaning Scale (RRMS) and sleep quality as measured by the PROMIS Sleep Disturbance measure and the PROMIS Sleep-Related Impairment Measure (SRI).
3h1: the RRMS mean scores will increase and PROMIS Sleep Disturbance and SRI mean scores will decrease in both study arms from baseline to Week 8, from Week 8 to Week 16, and from baseline to Week 16.
3h2: the RRMS mean scores and the PROMIS Sleep Disturbance and SRI mean scores will not differ between the two arms at baseline, Week 8 or at Week 16.
- Determine the impact of the intervention periods (Week 8, Week 16) on a patient-related indicator, Medication Administration Error as compared to the error rate at baseline.
4h1: Medication Administration Errors will not differ between the two study arms at baseline, Week 8 or at Week 16.
4h2: Medication Administration Errors will decrease within both study arms from baseline to Week8, and from Week 8 to Week 16.
General Design Description The study design is a cluster cross-over randomized trial involving 11 inpatient units at a freestanding pediatric hospital. In the randomization, the 11 units will be randomized to two study arms (Arm A - mindfulness intervention plus sleep hygiene information; Arm B - physical activity plus sleep hygiene information) during the first 8-week study period. Immediately following this study period, the units assigned to each arm will cross and receive the intervention not received in the first study period plus the ongoing access to the previous intervention. Both arms in the first study period will have education content specific to sleep hygiene connected to the existing napping option.
The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods. Interventions, such as physical activity and mindfulness, that can be done at the group level and may be more effective when done with a group, are ideal for this design (Arnup et al., 2014; Arnup et al., 2017; Parienti \& Kuss, 2007; Moerbeek, 2020; Reich et al., 2012). This design is also selected for its efficiency and reduced costs compared with a clinical trial with individuals being randomized (Taljaard et al, 2013).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods.
| Arm | Type | Receives |
|---|---|---|
| Arm A, Study Period 1 (Mindfulness and Sleep Hygiene): | Experimental | Behavioral: Mindfulness and Sleep HygieneImmediately after the sleep hygiene content, the overview of the mindfulness intervention will be offered. All enrolled participants in Arm A, Study Period 1, will attend a 15 minute in-person "Introduction to Mindfulness" session after randomization. |
| Arm B, Study Period 1 (Physical Activity and Sleep Hygiene): | Active comparator | Behavioral: Phyical activity and Sleep HygieneAll enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be nurses and members of the nursing care team that work the nightshift fulltime or that rotate from the dayshift to the nightshift on a routine basis. Participants will need to be scheduled to work at least 2 weeks of the nightshift during each study period (Study Period 1, Study Period 2) to be fully eligible to participate in the study. To be fully eligible, participants must be able to complete a consent process and understand the study design and the self-report periods.
Key exclusion criteria (1 listed)
- Exclusion criteria would include nurses and nursing care team members who do not rotate regularly to the nightshift or who work only the dayshift.
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 |
|---|---|---|
| Mindfulness and Sleep HygieneParticipants will experience demonstrations and explanations regarding sleep hygiene, mindfulness alerts for at work and mindfulness rest for at home. | Behavioural | Arm A, Study Period 1 (Mindfulness and Sleep Hygiene): |
| Phyical activity and Sleep HygieneAll enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods | Behavioural | Arm B, Study Period 1 (Physical Activity and Sleep Hygiene): |
Primary outcome
Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21).
Time frame: baseline or the week before randomization, Week 8 and Week 16
The ProQOL contains two domains: Compassion Satisfaction and Compassion Fatigue. For this study, we shall administer the ProQOL-21, a revised version of the ProQOL derived from a Rasch analysis (Heritage, et al., 2018) where higher scores mean better professional quality of life.
1 secondary outcome
change in Role-Related Meaning
Time frame: Baseline or the week before randomization, Week 8 and Week 16
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 18 Jun 2024.
- Individual participant dataSharing planned: Yes. Group summary will be provided to all upon request immediately after their publication by the study team.
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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.
Pamela Hinds, PhD, RN principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Sleep Hygiene and Phyical activity and Sleep Hygiene in people with Professional Quality of Life, run by Children's National Research Institute at 1 site in United States.
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 1 inclusion and 1 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21). (time frame: baseline or the week before randomization, Week 8 and Week 16). 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 18 Jun 2024.