The Distinct Effects of Mind-Body Modalities on Health Outcomes in Nursing Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Biomarkers
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Jordanian undergraduate nursing students
- •Being 18 years old or older.
- •Taking a clinical course.
排除标准
- •Practicing any type of relaxation techniques, such as yoga, guided imagery, meditation, cognitive behavioral therapy.
- •Taking hypnotics, sedatives, anxiolytic, anti-depressant, anti-inflammatory drugs.
研究组 & 干预措施
Nursing students receiving progressive muscle relaxation
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].
干预措施: Progressive muscle relaxation (Behavioral)
Nursing students receiving guided imagery
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].
干预措施: Guided Imagery (Behavioral)
Nursing student receiving mindfulness meditation
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].
干预措施: Mindfulness Meditation (Behavioral)
control Group
Participants 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.
干预措施: Control group (Other)
结局指标
主要结局
Biomarkers
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Mindfulness(6 weeks)
- Negative Emotions(6 weeks)
- Perceived stress(6 weeks)
- Coping behaviors(6 weeks)