MindfulnessMBINCT06400381
Effectiveness of Mindfulness-Based Interventions on Professional Quality of Life, Work Engagement, and Sleep Quality
A study testing Mindfulness in people with Mindfulness, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The aim of this study is to examine the impact of a mindfulness-based intervention on professional quality of life, work engagement, and sleep quality in pediatric and neonatal nurses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mindfulness
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2023to 1 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Jordanian nurses
- nurses have at least one year experience in workplace setting
Who cannot join
- nurse manager
- staff have previous experience with any type of mindfulness-based intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness-Based Interventions on Professional Quality of Life, Work Engagement, and Sleep Quality Among Pediatric Nurses in Jordan
The aim of this study is to examine the impact of a mindfulness-based intervention on professional quality of life, work engagement, and sleep quality in pediatric and neonatal nurses. A quasi-experimental pretest-posttest design will be used to evaluate the effectiveness of the mindfulness-based intervention on professional quality of life, work engagement, and sleep quality among pediatric and neonatal nurses. Pediatric and neonatal nurses (number = 208) will be conducted at King Abdullah Hospital, Rahmah Hospital, Al-Basher Hospital, and Jordan University Hospital after getting the Institutional Review Board (IRB) approval from Jordan University of Science and Technology, in addition to the IRB from the Ministry of Health. The nurses will be allocated into two groups, one as an interventional group and one as a control group, and the participants will be asked to complete the pretest questionnaire (baseline pre-intervention) and then the post-test at the end of the intervention (8 weeks after baseline). Data will be collected using online questionnaires of the study variables and a demographic questionnaire for the participants. Data will be analyzed using the Statistical Package for the Social Sciences (version 26).
Read the detailed description
The main goal of this study is to assess professional quality of life, work engagement, and sleep quality among nurses in a pediatric and neonatal unit in Jordan. A secondary aim was to examine the impact of a mindfulness-based intervention on nurses' professional quality of life, work engagement, and sleep quality in pediatric and neonatal nurses. Quasi-experimental pretest-posttest design with two groups will be used to achieve the primary study goal. Pretest-posttest quasi-experimental design, where the experimental group received the mindfulness intervention, and the control group received no intervention.
The study was conducted at four major hospitals in northern and central Jordan after getting IRB approval from the Jordan University of Science and Technology and research settings. The participants in this study Jordanian nurses were recruited from two different departments one is the Pediatric Intensive Care Unit (PICU) and the second department is Neonatal Intensive Care Unit (NICU).
The participants were invited to participate in the study through direct invitations by a member of the research team. The study was fully explained to them and informed consents were obtained from each individual participant. The nurses were assigned into two groups, one as an interventional group, and one as a control group. The intervention group who were willing to attend the mindfulness sessions participated in the intervention. The participants were invited to complete the data collection surveys to collect the baseline data. Then, the intervention group participants participated in the mindfulness-based intervention program. After completing the intervention, 8 weeks after baseline, post-intervention data were collected.
- Conditions
- Mindfulness
- Being tested
- Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
There are many mindfulness-based interventions protocol that can be implemented and practice by healthcare organization. In the current study, the intervention protocol the investigators will use is based on Smiths version of mindfulness meditation (Smith, 2005). This version is compromised of several components includes being mindful of breathing, thought, sounds, taste, body scan, and sitting. The initial educational session by power point presentation will be given to the participant to explain the intervention rationale and procedure of mindfulness in daily life. In addition to giving opportunity for the participant to ask questions during the educational session.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention | Experimental | There are many mindfulness-based interventions protocol that can be implemented and practice by healthcare organization. In the current study, the intervention protocol the investigators will use is based on Smiths version of mindfulness meditation (Smith, 2005). This version is compromised of several components includes being mindful of breathing, thought, sounds, taste, body scan, and sitting. The initial educational session by power point presentation will be given to the participant to explain the intervention rationale and procedure of mindfulness in daily life. In addition to giving opportunity for the participant to ask questions during the educational session. Receives: Behavioral: Mindfulness |
| Control | No intervention | The control group will not receive any intervention and will continue with their usual routines and work schedules. The control group completes the pretest questionnaire at the same time as the interventional group completes it, the posttest will be after the interventional group has finished the mindfulness intervention 8 weeks. The intervention sessions used in the experimental group will be delivered to the control group at the end of study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compassion fatigue
The Professional Quality of Life Scale, version 5 which consisted of 30 items to assess nurses in three subscales: compassion satisfaction (CS), Burnout (BO), and secondary traumatic stress (STS), each subscale comprised 10 items. Nurses respond to each item of this questionnaire based on a 5-point Likert-type scale ranging from 1 (Never) to 5 (Very Often). The total scores range from 22 to 42 for each subscale. The first range of score is 22 or less indicates to lower scores, between 23-41 indicates moderate scores, and last range 42 or more indicates higher scores for each 3 subscales
Measured: Change from baseline to 1-Month and 3 months post randomization
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI). The PSQI has 19 self-rated items grouped into seven components, these components are (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) use of sleeping medication, and (7) daytime dysfunction. Scoring ranges from 0-3 points for each of the 7 components. The seven component scores are then summed to yield a global PSQI score, the global score ranges between 0 to 21. 0 indicates no difficulty on sleep and 21 indicates significant poor in sleep quality, and the global cutoff score of 5. Nurses with a score from 0 to 5 were regarded to have a good sleep quality, whereas nurses with a score of 6 to 21 or more than 5 were considered to have a poor sleep quality.
Measured: Change from baseline to 1-Month and 3 months post randomization
Work Engagement
The Work Engagement Scale of Utrecht (UWES). The UWES consists of 17 items, and it includes three subscale of work engagement: Vigor (6 items), dedication (5 items), and absorption (6 items). Each item has a 7-point Likert response options ranging from 0 (Never) to 6 (Always). The total score for each subscale is calculated by summing the scores of the items in that dimension, the range of possible scores for each subscale is from 0 to 42. The total score for 17 items ranges from 0 to 102 with higher the scores indicating more nurses work engagement. For the sake of the current study, the investigators used the total score. The scores are classified as follows: very low (score < 5 percentile), low (5 percentile <= score < 25 percentile), average (25 percentile <= score < 75 percentile), high (75 percentile <= score < 95 percentile), and very high (95 percentile <= score).
Measured: Change from baseline to 1-Month and 3 months post randomization
Mindfulness
The Five Facets of Mindfulness Questionnaire (FFMQ). The FFMQ consists of 39 items that measures five facets of mindfulness: Acting with Awareness (8 items e.g., I am easily distracted), Non-Judging of Experience (8 items e.g., I criticize myself for having irrational or inappropriate emotions), Observing (8 items e.g., I notice the smells and aromas of things), non-reactivity (7 items e.g., I watch my feelings without getting lost in them), and Describing (8 items e.g., I'm good at finding the words to describe my feelings). Each item was rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ scores is calculated by summing the scores on each item. The scores range from 8 to 40 (with the exception of the non-reactivity score which range from 7 to 35), with higher scores viewing greater mindfulness.
Measured: Change from baseline to 1-Month and 3 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Nov 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted using a 1-month prospective quasi-experimental design. The participants in this study are Jordanian pediatric nurses from different pediatric departments four major hospital in northern and central Jordan. Based on G power a satisfactory sample size for two groups (experimental group and control group) with a power level of 0.8, significant alpha level of 0.05, and a moderate effect size of 0.25 will be at least 80 participants for each group and 160 in total. To count for potential attrition, the investigators added additional 30% of the total sample to the participant resulting in a total sample size of 208 (104 in each group).
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Mohammed Al-Hammouri, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400381
- Sponsor's protocol ID
- 20230532
- Acronym
- MBI
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared with other researchers. Only aggregate data will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-Based Interventions on Professional Quality of Life, Work Engagement, and Sleep Quality Among Pediatric Nurses in Jordan
- ClinicalTrials.gov ID
- NCT06400381
- Acronym / sponsor ID
- MBI / 20230532
- Conditions
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 6 May 2024 (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.
The aim of this study is to examine the impact of a mindfulness-based intervention on professional quality of life, work engagement, and sleep quality in pediatric and neonatal nurses. A quasi-experimental pretest-posttest design will be used to evaluate the effectiveness of the mindfulness-based intervention on professional quality of life, work engagement, and sleep quality among pediatric and neonatal nurses. Pediatric and neonatal nurses (number = 208) will be conducted at King Abdullah Hospital, Rahmah Hospital, Al-Basher Hospital, and Jordan University Hospital after getting the Institutional Review Board (IRB) approval from Jordan University of Science and Technology, in addition to the IRB from the Ministry of Health. The nurses will be allocated into two groups, one as an interventional group and one as a control group, and the participants will be asked to complete the pretest questionnaire (baseline pre-intervention) and then the post-test at the end of the intervention (8 weeks after baseline). Data will be collected using online questionnaires of the study variables and a demographic questionnaire for the participants. Data will be analyzed using the Statistical Package for the Social Sciences (version 26).
Detailed description
The main goal of this study is to assess professional quality of life, work engagement, and sleep quality among nurses in a pediatric and neonatal unit in Jordan. A secondary aim was to examine the impact of a mindfulness-based intervention on nurses' professional quality of life, work engagement, and sleep quality in pediatric and neonatal nurses. Quasi-experimental pretest-posttest design with two groups will be used to achieve the primary study goal. Pretest-posttest quasi-experimental design, where the experimental group received the mindfulness intervention, and the control group received no intervention.
The study was conducted at four major hospitals in northern and central Jordan after getting IRB approval from the Jordan University of Science and Technology and research settings. The participants in this study Jordanian nurses were recruited from two different departments one is the Pediatric Intensive Care Unit (PICU) and the second department is Neonatal Intensive Care Unit (NICU).
The participants were invited to participate in the study through direct invitations by a member of the research team. The study was fully explained to them and informed consents were obtained from each individual participant. The nurses were assigned into two groups, one as an interventional group, and one as a control group. The intervention group who were willing to attend the mindfulness sessions participated in the intervention. The participants were invited to complete the data collection surveys to collect the baseline data. Then, the intervention group participants participated in the mindfulness-based intervention program. After completing the intervention, 8 weeks after baseline, post-intervention data were collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be conducted using a 1-month prospective quasi-experimental design. The participants in this study are Jordanian pediatric nurses from different pediatric departments four major hospital in northern and central Jordan. Based on G power a satisfactory sample size for two groups (experimental group and control group) with a power level of 0.8, significant alpha level of 0.05, and a moderate effect size of 0.25 will be at least 80 participants for each group and 160 in total. To count for potential attrition, the investigators added additional 30% of the total sample to the participant resulting in a total sample size of 208 (104 in each group).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention | Experimental | Behavioral: MindfulnessThere are many mindfulness-based interventions protocol that can be implemented and practice by healthcare organization. In the current study, the intervention protocol the investigators will use is based on Smiths version of mindfulness meditation (Smith, 2005). This version is compromised of several components includes being mindful of breathing, thought, sounds, taste, body scan, and sitting. The initial educational session by power point presentation will be given to the participant to explain the intervention rationale and procedure of mindfulness in daily life. In addition to giving opportunity for the participant to ask questions during the educational session. |
| Control | No intervention | –The control group will not receive any intervention and will continue with their usual routines and work schedules. The control group completes the pretest questionnaire at the same time as the interventional group completes it, the posttest will be after the interventional group has finished the mindfulness intervention 8 weeks. The intervention sessions used in the experimental group will be delivered to the control group at the end of study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Jordanian nurses
- nurses have at least one year experience in workplace setting
Key exclusion criteria (2 listed)
- nurse manager
- staff have previous experience with any type of mindfulness-based intervention.
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 |
|---|---|---|
| MindfulnessThere are many mindfulness-based interventions protocol that can be implemented and practice by healthcare organization. In the current study, the intervention protocol the investigators will use is based on Smiths version of mindfulness meditation (Smith, 2005). This version is compromised of several components includes being mindful of breathing, thought, sounds, taste, body scan, and sitting. The initial educational session by power point presentation will be given to the participant to explain the intervention rationale and procedure of mindfulness in daily life. In addition to giving opportunity for the participant to ask questions during the educational session. | Behavioural | Mindfulness-based Intervention |
Primary outcome
Compassion fatigue
Time frame: Change from baseline to 1-Month and 3 months post randomization
The Professional Quality of Life Scale, version 5 which consisted of 30 items to assess nurses in three subscales: compassion satisfaction (CS), Burnout (BO), and secondary traumatic stress (STS), each subscale comprised 10 items. Nurses respond to each item of this questionnaire based on a 5-point Likert-type scale ranging from 1 (Never) to 5 (Very Often). The total scores range from 22 to 42 for each subscale. The first range of score is 22 or less indicates to lower scores, between 23-41 indicates moderate scores, and last range 42 or more indicates higher scores for each 3 subscales
Sleep Quality
Time frame: Change from baseline to 1-Month and 3 months post randomization
The Pittsburgh Sleep Quality Index (PSQI). The PSQI has 19 self-rated items grouped into seven components, these components are (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbance, (6) use of sleeping medication, and (7) daytime dysfunction. Scoring ranges from 0-3 points for each of the 7 components. The seven component scores are then summed to yield a global PSQI score, the global score ranges between 0 to 21. 0 indicates no difficulty on sleep and 21 indicates significant poor in sleep quality, and the global cutoff score of 5. Nurses with a score from 0 to 5 were regarded to have a good sleep quality, whereas nurses with a score of 6 to 21 or more than 5 were considered to have a poor sleep quality.
Work Engagement
Time frame: Change from baseline to 1-Month and 3 months post randomization
The Work Engagement Scale of Utrecht (UWES). The UWES consists of 17 items, and it includes three subscale of work engagement: Vigor (6 items), dedication (5 items), and absorption (6 items). Each item has a 7-point Likert response options ranging from 0 (Never) to 6 (Always). The total score for each subscale is calculated by summing the scores of the items in that dimension, the range of possible scores for each subscale is from 0 to 42. The total score for 17 items ranges from 0 to 102 with higher the scores indicating more nurses work engagement. For the sake of the current study, the investigators used the total score. The scores are classified as follows: very low (score < 5 percentile), low (5 percentile <= score < 25 percentile), average (25 percentile <= score < 75 percentile), high (75 percentile <= score < 95 percentile), and very high (95 percentile <= score).
Mindfulness
Time frame: Change from baseline to 1-Month and 3 months post randomization
The Five Facets of Mindfulness Questionnaire (FFMQ). The FFMQ consists of 39 items that measures five facets of mindfulness: Acting with Awareness (8 items e.g., I am easily distracted), Non-Judging of Experience (8 items e.g., I criticize myself for having irrational or inappropriate emotions), Observing (8 items e.g., I notice the smells and aromas of things), non-reactivity (7 items e.g., I watch my feelings without getting lost in them), and Describing (8 items e.g., I'm good at finding the words to describe my feelings). Each item was rated on a Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true). The FFMQ scores is calculated by summing the scores on each item. The scores range from 8 to 40 (with the exception of the non-reactivity score which range from 7 to 35), with higher scores viewing greater mindfulness.
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 6 May 2024.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared with other researchers. Only aggregate data will be disseminated.
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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.
Mohammed Al-Hammouri, PhD principal investigator
Jordan University of Science and Technology
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 in people with Mindfulness, run by King Abdullah University Hospital at 1 site in Jordan.
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 6 May 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 Jordan. 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?
Compassion fatigue (time frame: Change from baseline to 1-Month and 3 months post randomization). The study lists 4 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 6 May 2024.