NCT05099224

Brief Summary

Mindfulness meditation was used to reduce stress and its responses such as cortisol and C-reactive protein (CRP) among healthy and ill individuals in various cultures, but their effects have not yet been studied among Jordanian nursing students, experienced tremendous stress. Thus, the purpose of study was to examine the effects of three of such intervention on perceived stress (MM) on Trait mindfulness, perceived stress, cortisol, and CRP in Jordanian nursing students. The hypothesis was " mindfulness meditation will improve trait mindfulness, perceived stress, serum cortisol and serum CRP. Using a Randomized controlled study conducted in a large university in Jordan, 108 nursing students were randomly assigned to experimental and control groups equally. The experimental group participated in 5 30-minute weekly sessions of mindfulness meditation. Trait mindfulness, perceived stress, serum cortisol, and CRP were measured at baseline and end of intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

September 29, 2021

Last Update Submit

October 18, 2021

Conditions

Keywords

Nursing studentsStressC-reactive proteinsCortisolMindfulness meditation

Outcome Measures

Primary Outcomes (4)

  • Trait Mindfulness

    Trait mindfulness was measured using the Arabic version of the Mindful Attention Awareness Scale (MAAS) (28), which is a one-dimensional scale that includes 15 items measured on a six-point Likert-type scale ranging from 1 (almost always) to 6 (almost never). The total possible score ranges between 15 and 90, with higher scores indicating higher levels of trait mindfulness. The original scale has been shown to have strong psychometric properties when validated among college students (28). Further, the Arabic version of this scale has been shown to have excellent internal consistency and convergent validity for use among Arab populations (29). In the current study, the Cronbach's alpha for the Arabic version of the MAAS was .79, indicating good internal consistency.

    6 weeks

  • Perceived stress

    The Perceived Stress Scale (PSS) (30) is used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded). The scale comprises 10 items which are measured on a 5-point Likert scale (0=never, 4= very often) and which are relatively free of content specific to any subpopulation group. The total possible score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress (30). The PSS has been validated for use among college students, with internal consistency coefficients ranging from .84 to 36 and a test-retest reliability of .85 (30). The Arabic version of the PSS, which was used in the present study, has been shown to have adequate reliability and validity and is considered a suitable instrument for assessing perceived stress among Arab populations (31). In the current study, the Cronbach's alpha for the Arabic version of the PSS was .81, indicating good internal consistency.

    6 weeks

  • Serum cortisol

    The ELISA method has been found to be accurate, sensitive, specific, and precise in terms of determining the plasma concentration of cortisol (32). In the current study, the ELISA kit and protocols were used to analyze the blood sample for the serum cortisol (CEA462Ge) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).

    6 weeks

  • Serum CRP

    The ELISA kit and protocols were used to analyze the blood sample for the serum CRP (Cat no: SEA821Hu) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).

    6 weeks

Study Arms (2)

Experimental group receiving mindfulness meditation

EXPERIMENTAL

The ABC standardized version of mindfulness meditation was used, which includes 5 30-minute weekly sessions of mindfulness meditation. An additional 3-hour educational workshop about the rationale and procedures of intervention was provided before the actual training sessions. The intervention was supervised by PI is an experienced practitioner who received stress-management training at the Psychology Department at Kent State University The participants were asked to sit upright in a comfortable position, place their feet on the floor, and quietly observe and reflect on internal and external stimuli such as breathing, thought, feeling, physical sensation, and sound, without reactions, judgments, or evaluations.

Behavioral: Mindfulness meditation

Control group

NO INTERVENTION

Each of the control group subgroups had 10 participants. The participants were instructed to sit with their eyes closed and relax during the intervention sessions, in order to control for the nonspecific effects of trainer interaction, social interaction, attention, environment, time, and closed eyes. The timings of the control group interventions were similar to those of the experimental groups, whereby if a given experimental group intervention lasted for 30 minutes, the control group participants would be asked to sit with their eyes closed and relax for 30 minutes also.

Interventions

similar to the information included in arm/group descriptions

Experimental group receiving mindfulness meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study sample included undergraduate nursing students who were aged 18 years or over and taking a clinical course

You may not qualify if:

  • Students were excluded if they were practicing any type of relaxation techniques or taking hypnotics, sedatives, anxiolytics, anti-depressants, or anti-hypertensive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hossam AlHawatmeh

Irbid, None Selected, 22110, Jordan

Location

Related Publications (38)

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MeSH Terms

Conditions

Fractures, Stress

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hossam Alhawatmeh, PhD

    Jordan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data (questionnaire and blood samples) were collected by three research assistants with at least 10 years nursing experiences who were not involved in any other parts of the study. Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled Trial (pretest-posttests, two-group, randomized design)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 29, 2021

Study Start

October 1, 2020

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations