Mind-Body Modalities for Nursing Students
The Distinct Effects of Mind-Body Modalities on Health Outcomes in Nursing Students
1 other identifier
interventional
220
1 country
1
Brief Summary
Background: Nursing students around the world can experience tremendous stress due to their multi-faceted responsibilities. Stress is related to negative health and academic outcomes. Mind-body connection modalities have been used successfully to reduce stress and improve health among healthy and ill individuals in various cultures, but their effects have not yet been studied in the Arab culture. Thus, the purpose of this study was to examine and compare the effects of three of such modalities including progressive muscle relaxation (PMR), guided imagery (GI), and mindfulness meditation (MM) on stress and health outcomes in Jordanian nursing students. Methods: Using a randomized controlled design, 124 nursing students will be randomly assigned to 4 groups at a large university in Jordan. The 3 experimental groups (PMR, GI, and MM) will participate in 5 30-minute sessions (one session/week for 5 weeks) led by experienced trainers, in a private room during their clinical days. The control group will stay calm for 30 minutes during introducing the study interventions in another room at the university. The health outcomes will be measured at baseline (Time 1) and the end (Time 3) of the intervention in each group using different physical and self-report measures classified into different health categories such as cognitive health outcomes (executive brain function, stressful appraisal, mindfulness), physical health outcomes (e.g. physical symptoms, heart rate, blood pressure, neurobiological markers such as dopamine, serotonin, cortisol, adrenaline, and noradrenaline), and psychological health outcomes (e.g. depression, anxiety).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
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
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedFirst Submitted
Initial submission to the registry
November 24, 2021
CompletedFirst Posted
Study publicly available on registry
December 29, 2021
CompletedDecember 29, 2021
December 1, 2021
6 months
November 24, 2021
December 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Executive Functioning
The Barkley Deficits in Executive Functioning Scale- Short form (BDEFS-SF) (Adult version) will be used to measure executive functions including self-organization, self-restraint, self-motivation, self-regulation of emotion, and self-management to time. It is a self-reported scale consisting of 20 items measured using a 4-point Likert-type scale, ranging from Never or rarely (1) to Sometimes (2), Often (3), and Very often (4). The BDEFS-SF internal consistency was reported at an alpha of .92 in adult population. A confirmatory factor analysis supported the 5-factor structure of BDEFS in college students.
6 weeks
Depression
Depression will be measured by the General Health Questionnaire-9 (PHQ-9). It is reliable self-administered tool to evaluate the frequency of depressive symptoms in nursing students. It includes 9 items measured on a 4 likert scale (0= not at all, 3= nearly every day). The scores ranges from 0 to 27, with the higher scores indicated higher levels of depression.
6 weeks
Anxiety
Anxiety will be measured using the Greneral Health Questionnaire-7 (PHQ-7). It is a valid and reliable self-report questionnaire for assessing the frequency of symptoms of anxiety in nursing students. It includes 7 items measured on 4-point likert scale that ranges from 0 (not at all) to 3 (nearly every day0. The scores range from 0 to 21, with higher the total score indicates higher levels of anxiety.
6 weeks
Physical symptoms
The Patient Health Questionnaire -15 (PHQ-15) is a self-reported somatic symptoms subscale, derived from the full Patient-Health-Questionnaire. It is a 15-item instrument that assesses 15 common somatic symptoms. Subjects are 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.
6 weeks
Biomarkers
The procedure and protocol of ELISA will be followed to measure the concentrations of the neurotransmitters and hormones in plasma that include cortisol, C-reactive protein, Interleukins, melatonin, and leptin. Similar units of measurement will be used.
6 weeks
Secondary Outcomes (4)
Negative Emotions
6 weeks
Mindfulness
6 weeks
Perceived stress
6 weeks
Coping behaviors
6 weeks
Study Arms (4)
Nursing students receiving progressive muscle relaxation
EXPERIMENTALPMR (Smith Version) involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. This tense-let go exercise is performed twice for each muscle group. The tensing up phase for each muscle group should last for 5 to 10 seconds and the letting go phase for 20-30 seconds. Simultaneously, the subjects will be asked to pay attention to the sensations of muscle tension and relaxation. After the tense-let go exercise, subjects are asked to systematically scan the muscle groups to notice and let go any remaining muscle tension. The entire exercise should take around 30 minutes, not counting instructions and times of measurement \[11\].
Nursing students receiving guided imagery
EXPERIMENTALGuided imagery (Smith Version) involves creating in one's mind or imagining a passive relaxing places or activities. In sense imagery, one simply imagines sensations associated with a relaxing setting or activity. The relaxation approach involves the sense of sight, sound, touch, and smell. The categories of stimuli consist of: (1) Travel such as boats, plains, trains, balloons, horses, (2) outdoor nature settings such as mountains, gardens, and forest, (3) water such as rivers, lakes, ocean, beach, rain, and (4) indoor settings such as childhood home, castle, religious institution, and cabin \[11\].
Nursing student receiving mindfulness meditation
EXPERIMENTALSmith version of the mindfulness meditation will be used in the current study. The mindful mediators are neutral observers who view the world as it is, without reactions, judgments, and evaluations. They quietly attend to, note, and let go of every internal external stimulus such as thought, feeing, sensation, sound, idea that enters awareness. They do not try to think about, push away, and do anything with these stimuli experienced and do not have to figure out the connections between each stimulus. They simply let each stimulus come and go and wait for the next stimulus. They do not have to be concerned about distractions. Each time they are distracted, they note it as yet another passing stimulus (Ah, a distraction… how interesting") \[11\].
control Group
ACTIVE COMPARATORParticipants in the control condition will be instructed to sit with their eyes closed during the intervention periods. Participants in the control group will follow an identical time periods as the experimental groups. For instance, when the experimental groups will practice for 30 minutes, the participants in the control group will be asked to sit with eyes closed and relax for 30 minutes.
Interventions
PMR (Smith Version) involves a tense-let go exercise of 11 muscle groups including hand, arm, arm and sides, back, shoulder, face, front of neck, stomach, chest, leg, and foot. This tense-let go exercise is performed twice for each muscle group. The tensing up phase for each muscle group should last for 5 to 10 seconds and the letting go phase for 20-30 seconds. Simultaneously, the subjects will be asked to pay attention to the sensations of muscle tension and relaxation. After the tense-let go exercise, subjects are asked to systematically scan the muscle groups to notice and let go any remaining muscle tension. The entire exercise should take around 30 minutes, not counting instructions and times of measurement \[11\].
Guided imagery (Smith Version) involves creating in one's mind or imagining a passive relaxing places or activities. In sense imagery, one simply imagines sensations associated with a relaxing setting or activity. The relaxation approach involves the sense of sight, sound, touch, and smell. The categories of stimuli consist of: (1) Travel such as boats, plains, trains, balloons, horses, (2) outdoor nature settings such as mountains, gardens, and forest, (3) water such as rivers, lakes, ocean, beach, rain, and (4) indoor settings such as childhood home, castle, religious institution, and cabin \[11\].
Smith version of the mindfulness meditation will be used in the current study. The mindful mediators are neutral observers who view the world as it is, without reactions, judgments, and evaluations. They quietly attend to, note, and let go of every internal external stimulus such as thought, feeing, sensation, sound, idea that enters awareness. They do not try to think about, push away, and do anything with these stimuli experienced and do not have to figure out the connections between each stimulus. They simply let each stimulus come and go and wait for the next stimulus. They do not have to be concerned about distractions. Each time they are distracted, they note it as yet another passing stimulus (Ah, a distraction… how interesting") \[11\].
Participants in the control condition will be instructed to sit with their eyes closed and relax during the intervention periods. Participants in the control group will follow an identical procedure and time periods as the experimental groups. For instance, when the experimental groups will practice for 30 minutes, the participants in the control group will be asked to sit with eyes closed and relax for 30 minutes.
Eligibility Criteria
You may qualify if:
- Jordanian undergraduate nursing students
- Being 18 years old or older.
- Taking a clinical course.
You may not qualify if:
- Practicing any type of relaxation techniques, such as yoga, guided imagery, meditation, cognitive behavioral therapy.
- Taking hypnotics, sedatives, anxiolytic, anti-depressant, anti-inflammatory drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jordan University of Science and Technology
Irbid, None Selected, 22110, Jordan
Related Publications (26)
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PMID: 18504089BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hossam Alhawatmeh, PhD
Jordan University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2021
First Posted
December 29, 2021
Study Start
October 1, 2020
Primary Completion
March 30, 2021
Study Completion
May 30, 2021
Last Updated
December 29, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share