Trial Title:
Mindfulness Meditation: Alleviating Symptoms and Inflammation in Nurses
NCT ID:
NCT06635278
Condition:
Inflammation
Somatization
Conditions: Official terms:
Inflammation
Conditions: Keywords:
Mindfulness Meditation
Nurses
Somatic symptoms
Leptin
Interleukin-6
Tumor necrosis factor- alpha
Perceived stress
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
The outcome assessor will be blinded to the participants' group assignment
Intervention:
Intervention type:
Behavioral
Intervention name:
Mindfulness meditation
Description:
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)
Arm group label:
Nurses receiving mindfulness meditation
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.
Detailed description:
Introduction
The nursing profession has historically been associated with significant chronic stress
due to frequent exposure to various work-related stressors. These include psychological
or physical violence in the workplace, coping with patient deaths, staff shortages, and a
high patient load. The pandemic has added additional pressures and stressors, including
dealing with emergency patients, fear of exposure to the virus, increased working hours,
imbalance between work and personal life, disruption of family life, and inability to
adapt to a rapidly changing work environment. These unprecedented situations require
nurses to work long hours with more limited resources, which lead to sever level of
chronic stress.
Some nurses demonstrate resilience in the face of stress. However, most experience
prolonged stress that dysregulate physiological functions and reduce physical and
psychological health. According to Yaribeygi, et al. (2017) psychological stress is
associated with the activation of several body systems, including the hypothalamic
pituitary-adrenal axis and the sympathetic nervous system. The activation of these two
pathways results in elevated cortisol and catecholamines. Although the mechanism is still
not fully understood, chronic stress results in prolonged, excessive production of
cortisol, causing chronic release of pro-inflammatory factors such as InterLeukine-6
(IL-6) and TNFα. Such a chronic increase of proinflammatory markers in healthy
individuals is generally known as low-grade inflammation, which is associated to several
chronic illness such as cardiovascular disease, type 2 diabetes, metabolic syndrome and
major depression. Studies have revealed that persistent workplace stress lead to
increased inflammatory activity in healthcare professionals with unsatisfied working
conditions.
The elevated cortisol and catecholamines also puts nurses at increased risk of developing
somatic symptoms, known as physical complaints, that cannot be explained by medical
condition, mental disorder, or substance abuse. These complaints are often associated
with psychological stress and may involve sleep problems, digestive problems, heart
disease, palpitations, headache, weight gain and memory and concentration and muscle
tension. A recent systematic review investigating the prevalence of somatic symptoms
during the COVID-19 pandemic showed that such symptoms, including shortness of breath,
dyspnea, palpitations, and pain, were reported by 7.4% to 67% of patients, healthcare
workers, and the general population. Also, a study revealed that the overall prevalence
rates somatic symptoms among nurses during COVID-19 pandemic was 50%. Such symptoms
affect negatively nurses' quality of life and job performance, resulting in increased
errors in patient care.
The high prevalence of somatic symptoms and low-grade inflammation among healthcare
professionals, including nurses, indicates unmet needs within this population. Addressing
these needs requires implementing preventive strategies to enhance mental resilience,
particularly for high-risk individuals such as nurses. Mindfulness is one of the most
important methods used in psychotherapy, which is strongly associated with promotion
physical and psychological well-being, it is an effective method for reducing stress and
improving health. The practice of mindfulness originally began in Asian culture due to
meditative practices in Buddhist philosophy and eastern spiritual traditions; where it
emphasized the value of presence, non-exaggeration, and experience acceptance. In the
1970s and 1980s, mindfulness began to be used in Western countries, and it gradually
developed into one of the most important techniques in contemporary psychotherapy. In
recent years, the practice of mindfulness has been widely applied in both clinical and
non-clinical settings
. Several studies support the potential benefits of MBI on psychological health among
nurses. Duarte and Pinto-Gouveia reported that an abbreviated MBI resulted in significant
improvement in compassion fatigue, burnout, stress, life satisfaction and self-compassion
in oncology nurses. In a systematic review conducted by Chiappetta et al., MBI has been
found to significantly decrease stress, burnout, anxiety, and depression, and improve
self-compassion and quality of life among healthcare professionals. Similarly, Lomas et
al. in their systematic review supported these results, indicating that MBI significantly
reduced anxiety, depression, stress, and overall well-being in nurses. Lin et al.
conducted in randomized control trial and found that an eight-week MBSR program reduced
stress and negative affect while increasing positive affect and resilience among Chinese
nurses. Two other systematic review studies by Sulosaari et al. and Ramachandran et al.
found that MBI significantly improved psychological well-being, resilience, and quality
of life, while reducing stress, depression, and burnout among nurses.
However, rare studies examined the effect of such intervention on nurses' physical health
such as somatic symptoms and inflammation. MBI, as a holistic approach, has been found to
improve a wide range of health outcomes in different healthy and ill populations
including somatic symptoms and proinflammatory markers. The mechanism underlying the
effect of mindfulness intervention on somatic symptoms and inflammatory biomarkers can be
explained by the Cognitive Reappraisal Model. According to this model, the effects of
mindfulness practices on health outcomes are postulated to be mediated by improvement in
trait mindfulness and emotion regulation skills. Frequent mindfulness practice boosts the
mental capacity of mindfulness trait, known as present-moment awareness and
non-judgmental observation over thought and feelings. Such mental capacity helps people
become aware of and detach from the stressful thoughts and emotions by enabling cognitive
reappraisal as an emotion regulation skill. This is the process by which people can
re-interpret stressful events in less negative ways, resulting in lower perceived stress
levels. By alleviating perceived stress through cognitive reappraisal, mindfulness
intervention can improve the physiological responses associated with stress, such as the
activation of the hypothalamic-pituitary-adrenal (HPA) axis and the release of
proinflammatory biomarkers.
Research have supported the hypotheses of the Cognitive Reappraisal Model indicating the
mindfulness intervention can potentially reduce somatic symptoms and inflammatory
biomarkers (e.g. interleukin 6 and TNF-alpha) by reducing perceived stress. However, to
the best of our knowledge, these effects have not been examined among nurses in Jordan.
Thus, this study aimed to examine the effect of mindfulness intervention on perceived
stress, somatic symptoms, proinflammatory biomarkers such as interleukin 6 and TNF alpha.
Methods Design This was an experimental study using pretest post-test randomized
controlled design. This design is described as a plausible tool in terms of the control
on extraneous variables using various strategies, including manipulation, control group,
and random assignment. Participants were randomly assigned into the experimental and
control groups. Researchers who are not involved in the recruitment process and patient
assessment, were randomly assign the participants to the intervention group or the
control group, using a simple 1:1 computer-generated sequence.
Sample and setting The hospital can accommodate 750 beds, but in an emergency, that
number may be raised to 900. Participants who were having psychiatric illnesses,
disorders of the immune system (e.g., immunodeficiency or autoimmune disorders), and
current infections and taking anti-inflammatory or antimicrobial medications were
excluded.
G*Power software version 3.1 was used to calculate the required sample size. Based on an
independent t-test, with an alpha level of 0.05, a power of 0.8, and a moderate effect
size of 0.5, the required sample size was determined to be 102 participants.
Intervention The experimental group received eight 60-minute weekly sessions of MBI 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. This study researcher was an experienced
practitioner with a Ph.D. degree in nursing and received extensive stress management
training, including MBI at a Psychology Department at a university in the United States
10 years ago. Since then, he has been practicing the MBI daily. The audio recording of
the MBI was evaluated and validated for the clarity of voice and the MBI content by two
psychologists who are experts in MBI.
However, these eight weekly sessions were conducted by one of the study researchers to
explain the rationale and procedures of MBI including a demonstration of the entire MBI
protocol for the participants in the experimental group. He was also present during the
delivery of MBI session to confirm and facilitate the administration of the MBI sessions
and answer any participants' questions. This study researcher has a master's degree in
nursing and received extensive MBI training. The participants in the experimental groups
were encouraged not to share any information regarding the MBI with anyone during the
study.
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): Individuals pay attention in the
present moment without judgment.
- Meditation of the body (Rocking meditation): Individuals allow themselves to gently
rock back and forth in their chairs, effortlessly and quietly, while paying mindful
attention to the gentle, silent motion of the rocking
- Meditation of the body (Breathing meditation): Individuals allow their breathing to
flow naturally, free and easy, while simply focusing on the rhythm of the breath as
it moves in and out.
- Meditation of mind (Mentra meditation): Individuals allow a calming word, like
'peace,' to gently enter their minds, like an echo in the distance, while quietly
and effortlessly focusing as the word repeats over and over
- Meditation of mind (visual Image): Individuals visualize a simple spot of light,
such as a candle flame or a star, and quietly focus their attention on it.
- Meditation of sense (External image): Individuals slowly open their eyes halfway and
gently gaze at a certain object (e.g. candle) in front of them
- Meditation of the senses (A sound): Individuals choose a quiet, continuous sound and
gently focus their attention on it
- Open monitoring (Mindfulness): Nurses quietly observe, acknowledge, and release
every internal and external stimulus-such as thoughts, feelings, sensations, sounds,
and ideas-that enters their awareness. They refrain from analyzing, resisting, or
trying to manage these experiences and do not concern themselves with the
connections between each stimulus. Instead, they simply allow each stimulus to arise
and fade away, patiently waiting for the next one.
Participants in the control group were not asked to do anything during the study, except
their traditional practices. However, mindfulness meditation was provided to them after
the study.
Data collection and Ethical consideration Following IRB approval, one of the study
researchers contacted the hospital administrators to seek permission to conduct the
study. Once approval was granted, the nurses were approached in person, and the study's
purpose was explained to them. Those who agreed to participate were asked to sign a
consent form. Participants' confidentiality and anonymity were strictly maintained. A
researcher not involved in recruitment or patient assessment then randomly assigned
participants to either the intervention or control group using a simple 1:1
computer-generated sequence. The mindfulness-based intervention (MBI) schedule was
provided to participants in the experimental group, aligned with their work schedules.
Baseline and post-intervention measurements were conducted at the hospital by a
researcher (nurse). To minimize measurement errors due to variations in data collection,
self-reported measures were completed after the objective measures, such as biological
markers, to reduce stress-related biases. All measurements for both the intervention and
control groups were taken under consistent conditions, including room temperature and
environment, by a well-trained nurse with a master's degree in nursing. The ELISA
protocol for blood sampling was meticulously followed, and neurotransmitter and hormone
levels were measured at 8 a.m. for all participants, who were seated during testing.
Statistical Analysis Data were analyzed using the Statistical Package for Social Science
(SPSS), Version 26. Descriptive statistics were used to describe the study participants
as appropriate. For instance, frequency and percentage were used to describe the
categorical variables, while mean and standard deviation (SD) were used to describe the
continuous variables. Also, the baseline statistical equivalence between the study groups
on the dependent and sociodemographic variables was evaluated using independent t-tests.
Dependent t-tests were used to examine if there were statistically significant changes
between the pretest and posttest in each study group. Finally, independent t-tests were
used to examine if there was a statistically significant difference between the
experimental and control group at the end of the intervention.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Nurse working in the hospital in Jordan
- Being at least 21 years old
- Having a smartphone
- Being able to read and write in English
Exclusion Criteria:
- Having psychiatric illnesses
- Having disorders of the immune system (e.g., immunodeficiency or autoimmune
disorders) and current infections.
- Taking anti-inflammatory or antimicrobial medications
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
King Abdullah University Hospital
Address:
City:
Irbid
Zip:
22110
Country:
Jordan
Start date:
August 1, 2024
Completion date:
October 10, 2024
Lead sponsor:
Agency:
Jordan University of Science and Technology
Agency class:
Other
Source:
Jordan University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635278
