The Distinct Effects of Mind-Body Modalities on Health Outcomes in Nursing Students
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 220
- Locations
- 2
- Primary Endpoint
- Biomarkers
Study Overview
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).
Detailed Description
Design
This study uses a blocked randomized controlled design. The study subjects will be selected using a convenience sampling method. When selected, the subjects will be randomly assigned to either one of the 4 study groups using a stratified random strategy (stratifying variable= academic year of study). The study groups (PMR, MM, GI, Control group) will received 5 30-minute weekly sessions of their assigned intervention over 5 weeks. However, there will be a 4-hours workshop explaining the purposes and techniques of the study interventions before introducing the actual session. The subjects will be asked and encouraged to practice their assigned intervention for 30 minutes daily at home. The dependent variables will be measured three times for the 4 groups: at baseline, at the middle (after the second session), and at the end of intervention.
Participants
Participants are undergraduate nursing students who will be selected using a random sampling method from Jordan University of Science and Technology.
Determination of Sample Size
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Jordanian undergraduate nursing students
- •Being 18 years old or older.
- •Taking a clinical course.
Exclusion Criteria
- •Practicing any type of relaxation techniques, such as yoga, guided imagery, meditation, cognitive behavioral therapy.
- •Taking hypnotics, sedatives, anxiolytic, anti-depressant, anti-inflammatory drugs.
Outcomes
Primary Outcomes
Biomarkers
Time Frame: 6 weeks
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.
Anxiety
Time Frame: 6 weeks
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.
Depression
Time Frame: 6 weeks
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.
Physical symptoms
Time Frame: 6 weeks
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.
Executive Functioning
Time Frame: 6 weeks
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.
Secondary Outcomes
- Mindfulness(6 weeks)
- Negative Emotions(6 weeks)
- Perceived stress(6 weeks)
- Coping behaviors(6 weeks)