Stress, Psychological Clinical Trial
Official title:
The Distinct Effects of Mind-Body Modalities on Health Outcomes in Nursing Students
NCT number | NCT05172804 |
Other study ID # | 5/121/2019 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | May 30, 2021 |
Verified date | December 2021 |
Source | Jordan University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 220 |
Est. completion date | May 30, 2021 |
Est. primary completion date | March 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Jordan | Jordan University of Science and Technology | Irbid | None Selected |
Lead Sponsor | Collaborator |
---|---|
Jordan University of Science and Technology |
Jordan,
Barkley RA. Barkley deficits in executive functioning scale (BDEFS). Guilford Press; 2011 Feb 1.
Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. — View Citation
Chan CK, So WK, Fong DY. Hong Kong baccalaureate nursing students' stress and their coping strategies in clinical practice. J Prof Nurs. 2009 Sep-Oct;25(5):307-13. doi: 10.1016/j.profnurs.2009.01.018. — View Citation
Coffman TP. The psychometric properties of the Barkley Deficits in Executive Functioning Scale (BDEFS) in a college student population (Doctoral dissertation). The Florida State University, 2014.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. — View Citation
Evans W, Kelly B. Pre-registration diploma student nurse stress and coping measures. Nurse Educ Today. 2004 Aug;24(6):473-82. — View Citation
Gillani NB, Smith JC. Zen meditation and ABC relaxation theory: an exploration of relaxation states, beliefs, dispositions, and motivations. J Clin Psychol. 2001 Jun;57(6):839-46. — View Citation
Higginbotham, H. (2013). A psychoeducational approach to improving college student mental health. (Electronic Thesis or Dissertation).
Kinlein SA, Karatsoreos IN. The hypothalamic-pituitary-adrenal axis as a substrate for stress resilience: Interactions with the circadian clock. Front Neuroendocrinol. 2020 Jan;56:100819. doi: 10.1016/j.yfrne.2019.100819. Epub 2019 Dec 19. Review. — View Citation
Knight EL, Jiang Y, Rodriguez-Stanley J, Almeida DM, Engeland CG, Zilioli S. Perceived stress is linked to heightened biomarkers of inflammation via diurnal cortisol in a national sample of adults. Brain Behav Immun. 2021 Mar;93:206-213. doi: 10.1016/j.bbi.2021.01.015. Epub 2021 Jan 28. — View Citation
Kocalevent RD, Hinz A, Brähler E. Standardization of a screening instrument (PHQ-15) for somatization syndromes in the general population. BMC Psychiatry. 2013 Mar 20;13:91. doi: 10.1186/1471-244X-13-91. — View Citation
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation
Kwekkeboom KL, Wanta B, Bumpus M. Individual difference variables and the effects of progressive muscle relaxation and analgesic imagery interventions on cancer pain. J Pain Symptom Manage. 2008 Dec;36(6):604-15. doi: 10.1016/j.jpainsymman.2007.12.011. Epub 2008 May 27. — View Citation
Markozannes G, Koutsioumpa C, Cividini S, Monori G, Tsilidis KK, Kretsavos N, Theodoratou E, Gill D, Ioannidis JP, Tzoulaki I. Global assessment of C-reactive protein and health-related outcomes: an umbrella review of evidence from observational studies and Mendelian randomization studies. Eur J Epidemiol. 2021 Jan;36(1):11-36. doi: 10.1007/s10654-020-00681-w. Epub 2020 Sep 25. Review. — View Citation
Matsumoto M, Smith JC. Progressive muscle relaxation, breathing exercises, and ABC relaxation theory. J Clin Psychol. 2001 Dec;57(12):1551-7. — View Citation
Prato CA, Yucha CB. Biofeedback-assisted relaxation training to decrease test anxiety in nursing students. Nurs Educ Perspect. 2013 Mar-Apr;34(2):76-81. — View Citation
Pulido-Martos M, Augusto-Landa JM, Lopez-Zafra E. Sources of stress in nursing students: a systematic review of quantitative studies. International Nursing Review. 2012 Mar;59(1):15-25.
Rathnayake S, Ekanayaka J. Depression, anxiety, and stress among undergraduate nursing students in a public university in Sri Lanka. International Journal of Caring Sciences. 2016 Sep 1;9(3):1020-32.
Ren L, Wang Y, Wu L, Wei Z, Cui LB, Wei X, Hu X, Peng J, Jin Y, Li F, Yang Q, Liu X. Network structure of depression and anxiety symptoms in Chinese female nursing students. BMC Psychiatry. 2021 May 31;21(1):279. doi: 10.1186/s12888-021-03276-1. — View Citation
Shaban IA, Khater WA, Akhu-Zaheya LM. Undergraduate nursing students' stress sources and coping behaviours during their initial period of clinical training: a Jordanian perspective. Nurse Educ Pract. 2012 Jul;12(4):204-9. doi: 10.1016/j.nepr.2012.01.005. Epub 2012 Jan 26. — View Citation
Sheu S, Lin HS, Hwang SL. Perceived stress and physio-psycho-social status of nursing students during their initial period of clinical practice: the effect of coping behaviors. Int J Nurs Stud. 2002 Feb;39(2):165-75. — View Citation
Shields GS, Sazma MA, Yonelinas AP. The effects of acute stress on core executive functions: A meta-analysis and comparison with cortisol. Neurosci Biobehav Rev. 2016 Sep;68:651-668. doi: 10.1016/j.neubiorev.2016.06.038. Epub 2016 Jun 28. Review. — View Citation
Smith JC. Relaxation, meditation, & mindfulness: A mental health practitioner's guide to new and traditional approaches. Springer Publishing Company; 2005 Mar 4.
Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation
Westermann J, Hubl W, Kaiser N, Salewski L. Simple, rapid and sensitive determination of epinephrine and norepinephrine in urine and plasma by non-competitive enzyme immunoassay, compared with HPLC method. Clin Lab. 2002;48(1-2):61-71. — View Citation
Wolf L, Stidham AW, Ross R. Predictors of stress and coping strategies of US accelerated vs. generic Baccalaureate Nursing students: an embedded mixed methods study. Nurse Educ Today. 2015 Jan;35(1):201-5. doi: 10.1016/j.nedt.2014.07.005. Epub 2014 Aug 2. — View Citation
* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Negative Emotions | The negative emotions will be measured by the Depression, Anxiety and Stress Scale - 21 (DASS-21). It includes 3 self-administered subscales developed to assess the negative emotional states of depression, anxiety and stress. The total scores for each subscale ranges from 0 to 42, with higher scores indicating more depression, anxiety and stress. | 6 weeks | |
Secondary | Mindfulness | Mindful Attention Awareness Scale (MAAS) will be 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 acceptable level of reliability and validity in university students. | 6 weeks | |
Secondary | Perceived stress | 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 include 10 items measured on a 5-point Likert scale (0=never, 4= very often), which are relatively free of content specific to any subpopulation group. The scores range from 0 to 40 with higher score indicating higher levels of perceived stress. PSS has been validated for use with college students. | 6 weeks | |
Secondary | Coping behaviors | Nursing students' self-directed coping behaviors will be assessed by the Coping Behaviors Inventory (CBI). The CBI is used to identify nursing students' coping behaviors. It includes nineteen 5-point Likert-type items divided into four factors: avoidance behavior (efforts to avoid a stressful situation), 6 items; problem-solving behavior (efforts to manage or change the stress arising out of a stressful situation), 6 items; optimistic coping behavior (efforts to keep a positive attitude toward the stressful situation), 4 items; and transference behavior (efforts to transfer one's attention from the stressful situation to other things), 3 items. Higher scores for each factor indicate more frequent use and greater effectiveness of a certain type of coping behavior. It showed an acceptable levels of reliability and validity in nursing students. | 6 weeks |
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