Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06400381
Other study ID # 20230532
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date April 1, 2024

Study information

Verified date May 2024
Source King Abdullah University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 208
Est. completion date April 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Jordanian nurses - nurses have at least one year experience in workplace setting Exclusion Criteria: - nurse manager - staff have previous experience with any type of mindfulness-based intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness
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.

Locations

Country Name City State
Jordan Alabdali Hospital Amman

Sponsors (2)

Lead Sponsor Collaborator
King Abdullah University Hospital Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline to 1-Month and 3 months post randomization
Primary 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. Change from baseline to 1-Month and 3 months post randomization
Primary 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). Change from baseline to 1-Month and 3 months post randomization
Primary 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. Change from baseline to 1-Month and 3 months post randomization
See also
  Status Clinical Trial Phase
Completed NCT03614390 - Mindfulness for Medical Students N/A
Recruiting NCT06038942 - Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress N/A
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Completed NCT02869854 - Increased Physical Activity Through Mindfulness N/A
Not yet recruiting NCT02894203 - Psychobiological Effects of Meditation on Offenders With Psychopathy N/A
Completed NCT02157766 - Wisconsin Center for the Neuroscience and Psychophysiology of Meditation N/A
Recruiting NCT05020301 - Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging N/A
Not yet recruiting NCT04496115 - Mindfulness in High Risk Pregnancies N/A
Completed NCT05516108 - Remote Mindfulness Training Following Early Life Adversity Phase 1
Completed NCT04930081 - The Effectiveness and Underlying Mechanisms of Parent Management Training and Mindful Parenting Program N/A
Completed NCT04927026 - "Where-there-is-no-psychiatrist Integrated Personal Therapy" Among Community-Dwelling Older Adults N/A
Completed NCT05085847 - Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being N/A
Completed NCT03495310 - Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial N/A
Recruiting NCT04733300 - Online Mindfulness-Based College for Young Adults N/A
Completed NCT04416529 - Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group N/A
Completed NCT05538650 - RCT: Mindfulness for Social Work and Self-care N/A
Completed NCT05994911 - Mindfulness Education in Adolescents N/A
Recruiting NCT05568030 - Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm N/A
Completed NCT06090760 - Mindfulness Intervention and Online Social Networking N/A
Completed NCT04929613 - Resilience Training for First Responders in the Opioid Epidemic N/A