Mindfulness Meditation: Alleviating Symptoms and Inflammation in Nurses

NCT06635278 | Active Not Recruiting

• 1 other identifier: 2024/319
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Nurses have experienced several stressors, the most important of which are increased workloads, long shifts, patients' negative results, some patients not responding to treatment, death at high rates, late detection of disease cases, lack of social support system, and limited typical coping. Aim: The purpose of this study is to assess the effectiveness of mindfulness meditation for clinical nurses to improve perceived stress and somatic symptoms and pro-inflammatory factors. Among Jordanian clinical nurses. Methodology: The study will be conducted using a post-test randomized controlled experimental design. The study data will be collected using a self-report questionnaire and blood sampling from 102 nurses in in King Abdullah hospitals at baseline and at the end of intervention. Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26.

Conditions

Inflammation; Somatization

Keywords

Mindfulness Meditation; Nurses; Somatic symptoms; Leptin; Interleukin-6; Tumor necrosis factor- alpha; Perceived stress

Outcome Measures

Primary Outcomes (4)

• Mindful Attention Awareness Scale

  Mindful Attention Awareness Scale (MAAS) (Brown \& Ryan, 2003) was used to measure dispositional mindfulness. It is one-dimensional scale including 15 items measured on a six-point likert type scale, ranging from 1 (almost always) to 6 (almost never). The score range is between 15 and 90, with higher score indicting higher levels of mindfulness. The scale has shown strong psychometric properties when validated in college students. It showed single-factor construct in MAAS structure and a Chronbach's alpha of 0.82 in university sample. Correlational, quasi-experimental, and laboratory studies have shown that the MAAS taps a unique quality of consciousness that is related to, predictive of, a variety of self-regulation and well-being constructs. The Arabic version showed acceptable levels of validity and reliablity in an Arab population and nursing students.

  From enrollment to the end of intervention at 8 weeks

• Perceived Stress Scale

  The Perceived Stress Scale (PSS) is used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded). It composes of 10 items rated on a 5-point Likert scale (0=never, 4= very often), which are relatively free of content specific to any subpopulation group. The total scores of the scale range from 0 to 40, with higher scores indicating higher levels of perceived stress (Cohen et al., 1983). PSS has been validated among college students. Internal consistency coefficients for the PSS ranged from .84 to 36, and test- retest reliability was .85 (Cohen et al., 1983). The Arabic version of the scale demonstrated an acceptable level of reliability and validity among Arabic adult population (Almadi, et al., 2012).

  From enrollment to the end of intervention at 8 weeks

• The Patient Health Questionnaire-15

  The The Patient Health Questionnaire-15 (PHQ-15) is a self-reported somatic symptoms subscale, derived from the full Patient-Health-Questionnaire (Spitzer, et al., 1999; Löwe, Zipfel, Herzog, 2002; Kroenke et al., 2002). It is a 15-item instrument that assesses 15 common somatic symptoms. Subjects were asked to rate the severity of symptoms as 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"). The score ranges from 0 to 30 and scores of ≥5, ≥10, ≥15 represent mild, moderate and severe levels of somatization respectively. Evidence supports reliability and validity of the PHQ-15 as a measure of physical symptoms in the general population. The scores of the PHQ-15 were highly correlated with the scores of depressions and the physical component summary scale of health-related quality of life (Kocalevent, Hinz, \&Brähler, 2013). The internal consistency (Cronbach's α) for the PHQ-15 was 0.82 (Kocalevent, Hinz, \& Brähler, 2013).

  From enrollment to the end of intervention at 8 weeks

• Change in serum levels of inflammatory biomarkers (Leptin, IL-6, TNF-α) as measured by ELISA

  The blood sampling and analysis protocol for inflammatory biomarkers (leptin, IL-6, and TNF-α) was rigorously followed using the ELISA technique. Blood samples were collected via venipuncture, stored at 4°C, and processed within two hours to maintain integrity. Plasma or serum was separated by centrifugation and stored at -80°C until analysis. Biomarker levels were quantified in ng/mL for leptin and pg/mL for IL-6 and TNF-α, following specific ELISA procedures. Elevated levels of these biomarkers indicate increased low-grade inflammation. Overall, the analysis reflects systemic inflammation and aids in assessing patients' inflammatory status.

  From enrollment to the end of intervention at 8 weeks

Study Arms (2)

Nurses receiving mindfulness meditation

EXPERIMENTAL

The experimental group received eight 60-minute weekly sessions of mindfulness meditation over eight weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The theory-based program (Smith, 2005) includes the ABC standardized versions of MBI (Smith, 2005), described as follows: * Body sense meditation * Rocking meditation * Breathing meditation * Mentra meditation * Visual Image meditation * External image meditation * Meditation of a sound * Open monitoring (Mindfulness) meditation

Behavioral: Mindfulness meditation

Nurses will receive no intervention or materials from the experimenter

NO INTERVENTION

Control group will receive a traditional care provided usually for patients in the hospital

Interventions

Mindfulness meditation BEHAVIORAL

The experimental group received eight 60-minute weekly sessions of mindfulness meditation over eight weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by a study researcher based on the Smith's (2005) protocol. The theory-based program (Smith, 2005) includes the ABC standardized versions of MBI (Smith, 2005), described as follows: * Meditation of the body (Body sense meditation) * Meditation of the body (Rocking meditation) * Meditation of the body (Breathing meditation) * Meditation of mind (Mentra meditation) * Meditation of mind (visual Image) * Meditation of sense (External image) * Meditation of the senses (A sound) * Open monitoring (Mindfulness)

Nurses receiving mindfulness meditation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nurse working in the hospital in Jordan
• Being at least 21 years old
• Having a smartphone
• Being able to read and write in English

You may not qualify if:

• Having psychiatric illnesses
• Having disorders of the immune system (e.g., immunodeficiency or autoimmune disorders) and current infections.
• Taking anti-inflammatory or antimicrobial medications

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

King Abdullah University Hospital

Irbid, None Selected, 22110, Jordan

Location

Related Publications (21)

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• Alhawatmeh H, Abusaif L, Alharrasi M, Abuhammad S. Impact of Mindfulness Meditation on Perceived Stress, Somatic Symptoms and Inflammatory Biomarkers Among Clinical Nurses. J Nurs Scholarsh. 2026 Jan;58(1):e70067. doi: 10.1111/jnu.70067.

  PMID: 41580885 DERIVED

MeSH Terms

Conditions

Inflammation; Medically Unexplained Symptoms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hossam Alhawatmeh, Doctoral degree

  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 outcome assessor will be blinded to the participants' group assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: August 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 10, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)