Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000389707
Ethics application status
Approved
Date submitted
20/09/2021
Date registered
7/03/2022
Date last updated
16/02/2023
Date data sharing statement initially provided
7/03/2022
Date results provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A mindfulness-based intervention aimed at behavioral and psychological wellbeing of nurses
Scientific title
The Effect of Mindfulness-Based Intervention on Behavioral and Psychological Variables among Jordanian Nurses: A Randomized Controlled Trial Study
Secondary ID [1] 305358 0
529-2021
Universal Trial Number (UTN)
Trial acronym
MM-BP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 324451 0
Stress 324452 0
Condition category
Condition code
Public Health 321229 321229 0 0
Health promotion/education
Mental Health 321938 321938 0 0
Depression
Mental Health 321939 321939 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention protocol is similar to the brief mindfulness-based stress reduction program designed by Mackenzie (2006). He synthesizes its main elements from Kabat-Zinn's (1990) traditional mindfulness-based stress reduction program. The participants will be recruited from nurses inside the hospital for the two intervention groups so that the 65 nurses will receive the mindfulness meditation session inside one of the hospital rooms equipped to deliver the intervention, and the second group of the 65 nurses who will receive the intervention in a natural setting outside the hospital (i.e. park or recreation center, that will be decided based on the funding to be determined after getting the IRB approval). Intervention groups will practice mindfulness meditation once weekly for 4 weeks as a group (i.e. 4 sessions for each of the two internevtional groups). There are no recommendations about group size in the literature, but we will use small group sizes between 10 and 20 participants in each session for convenience. Mindfulness-based intervention trainers will guide the mindfulness meditation sessions, and each session is 30 minutes long. The intervention comprises four 30-minute training sessions that cover the following topics: an introduction to mindfulness, typical barriers to practice, the repercussions of attachment and aversion to judging events, and methods for bringing mindfulness into one's daily life. The body scan, sitting meditation, and a brief three-minute breathing exercise for use in times of acute stress were all experienced components of the sessions (Mackenzie et al., 2006; Poulin et al., 2008). In addition, the participants in the intervention groups will be instructed to practice mindfulness mediation individually at home for at least 10 minutes daily for 5 days a week by using the audio recording and handout guides for mindfulness-based intervention. To assess and monitor participants' adherence to the intervention, participants will be asked about the frequency of performing the MM as a part of the follow-up data collection process. In addition, the researchers will maintain a record of attendance.
Intervention code [1] 321767 0
Behaviour
Intervention code [2] 322366 0
Treatment: Other
Comparator / control treatment
The control group will not receive any intervention during the study, but it will be on a waiting list to receive the same intervention after the finishing data collection for this study after 6 months after enrollment.
Control group
Active

Outcomes
Primary outcome [1] 329017 0
Psychological wellbeing. This is a composite primary outcome and it will include measurement of stress and depression.

Stress will be assessed using the Stress Overload Scale (SOS-10), it is divided into two subscales, Event load (E.L.): reflects perceived demands (e.g., “…felt swamped by your responsibilities”) and Personal Vulnerability (P.V.): reflects perceived inadequacy of resources to deal with those demands (e.g., “…felt like you couldn’t cope”)

Depression will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) . CESD-R is a 20-item scale with 4-piont Likert-like answer options from 1 (rarely or none of the time) to 4 ( most or all of the time).
Timepoint [1] 329017 0
Will be assessed immediately after randomization (pre-intervention as a baseline), immediately after the intervention, and 3 and 6 months after the end of the intervention. The final time point (6 months post-randomization) will be considered the primary endpoint.
Primary outcome [2] 329018 0
Behavioral change. This is a composite primary outcome that includes eating behavior, sleep, and work- and family-related conflict.

Eating Behavior will be assessed using the Three-Factor Eating Questionnaire (TFEQ-R21). TFEQ is a 21-items instrument that covers three eating behavioral scales: cognitive restraint, eating uncontrollably, and emotionally.

Sleep will be assessed by questions in the demographic questionnaire. These questions will ask about sleep duration, quality, frequency, and interruptions. The questions about sleep duration, frequency, quality, and interruptions were developed specifically for this study.

work- and family-related conflict will be assessed using the Work and Family Conflict Scale (WAFCS). It is a 10-item scale with two subscales; work-to-family conflict (Items 1 to 5) and family-to-work conflict (Items 6 to 10) subscales. Each item is scored on a 7-point Likert-like
Timepoint [2] 329018 0
Will be assessed immediately after randomization (pre-intervention as a baseline), immediately after the intervention, and 3 and 6 months after the end of the intervention. The final time point (6 months post-randomization) will be considered the primary endpoint.
Secondary outcome [1] 401178 0
Mindfulness will be measured using the five facet mindfulness questionnaire (FFMQ).
Timepoint [1] 401178 0
Will be assessed immediately after randomization (pre-intervention as a baseline), immediately after the intervention, and 3 and 6 months after the end of the intervention.
Secondary outcome [2] 403483 0
Participants' perceptions about effectiveness, facilitators, barriers, and acceptability of the intervention. This will be achieved through a series of interviews with participants from each interventional group. A semi-structured interview will be used to serve this purpose. This structure is deemed suitable to serve the main purpose of the interview by asking general open-ended questions about each aspect of the intervention that will be assessed through the interviews. the interviewee will be selected randomly from each interventional group, and the interviews will continue until we reach data saturation. the data from the interviews will be analyzed using thematic analysis using NVIVO version 12. We will use the same randomization technique used at the outset of the study to recruit interviewees.
Timepoint [2] 403483 0
Will be assessed 6 months after the end of the intervention.

Eligibility
Key inclusion criteria
1) Jordanian nurses
2) at least one-year experience in the workplace setting
3) don’t have previous experience with mindfulness meditation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Sealed opaque envelopes will be used to perform allocation concealment. The researchers will prepare a total of 195 envelopes as the following: 65 intervention-Hospital, 65 intervention-outside, and 65 control. the envelopes will be randomly distributed to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total sample of 152 nurses based on the medium size of the repeated-measures MANOVA test and power of 0.80 was deemed sufficient for evaluating the proposed relationships. Assuming an attrition rate of about 33%, the total required sample for this study will be around 195 staff nurses. The study participants will be randomly assigned into three groups (inside the hospital, safe community-based setting, and control). SPSS (version 26) will be used to analyze the data. We will examine the data using descriptive statistics and repeated-measures ANOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
10/04/2022
Date of last data collection
Anticipated
30/12/2022
Actual
1/09/2022
Sample size
Target
195
Accrual to date
Final
195
Recruitment outside Australia
Country [1] 24140 0
Jordan
State/province [1] 24140 0
Irbid

Funding & Sponsors
Funding source category [1] 309729 0
University
Name [1] 309729 0
Jordan University of Science and Technology
Country [1] 309729 0
Jordan
Primary sponsor type
University
Name
Jordan University of Science and Technology
Address
Jordan University of Science & Technology
P.O.Box 3030, Irbid 22110, Jordan
Country
Jordan
Secondary sponsor category [1] 310749 0
None
Name [1] 310749 0
Address [1] 310749 0
Country [1] 310749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309487 0
Jordan University of Science and Technology
Ethics committee address [1] 309487 0
Ethics committee country [1] 309487 0
Jordan
Date submitted for ethics approval [1] 309487 0
01/10/2021
Approval date [1] 309487 0
25/01/2022
Ethics approval number [1] 309487 0
529-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114318 0
Dr Mohammed Al-Hammouri
Address 114318 0
Jordan University of Science & Technology
P.O.Box 3030, Irbid 22110, Jordan
Country 114318 0
Jordan
Phone 114318 0
+962799494670
Fax 114318 0
Email 114318 0
[email protected]
Contact person for public queries
Name 114319 0
Mohammed Al-Hammouri
Address 114319 0
Jordan University of Science & Technology
P.O.Box 3030, Irbid 22110, Jordan
Country 114319 0
Jordan
Phone 114319 0
+962799494670
Fax 114319 0
Email 114319 0
[email protected]
Contact person for scientific queries
Name 114320 0
Mohammed Al-Hammouri
Address 114320 0
Jordan University of Science & Technology
P.O.Box 3030, Irbid 22110, Jordan
Country 114320 0
Jordan
Phone 114320 0
+962799494670
Fax 114320 0
Email 114320 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data sharing is under a third-party agreement. that restricts public data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13286Study protocol  [email protected] Direct contact with the PI through e-mail
13287Statistical analysis plan  [email protected] Direct contact with the PI through e-mail
13288Ethical approval  [email protected] Direct contact with the PI through e-mail



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.