NCT06400381

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

April 16, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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.

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.

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness-based Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Jordanian nurses
  • nurses have at least one year experience in workplace setting

You may not qualify if:

  • nurse manager
  • staff have previous experience with any type of mindfulness-based intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alabdali Hospital

Amman, Jordan

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mohammed Al-Hammouri, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2024

First Posted

May 6, 2024

Study Start

November 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared with other researchers. Only aggregate data will be disseminated.

Locations