Stress ReactionNCT05099224
Mindfulness Meditation for Nursing Students
A study testing Mindfulness meditation in people with Stress Reaction and Nurse's Role, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Mindfulness meditation was used to reduce stress and its responses such as cortisol and C-reactive protein (CRP) among healthy and ill individuals in various cultures, but their effects have not yet been studied among Jordanian nursing students, experienced tremendous stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Nurse's Role
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteJordan
- Study dates
- 1 Oct 2020to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study sample included undergraduate nursing students who were aged 18 years or over and taking a clinical course
Who cannot join
- Students were excluded if they were practicing any type of relaxation techniques or taking hypnotics, sedatives, anxiolytics, anti-depressants, or anti-hypertensive drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness Meditation on Psychoneuroendocrinoimmunology in Nursing Students
Mindfulness meditation was used to reduce stress and its responses such as cortisol and C-reactive protein (CRP) among healthy and ill individuals in various cultures, but their effects have not yet been studied among Jordanian nursing students, experienced tremendous stress. Thus, the purpose of study was to examine the effects of three of such intervention on perceived stress (MM) on Trait mindfulness, perceived stress, cortisol, and CRP in Jordanian nursing students. The hypothesis was " mindfulness meditation will improve trait mindfulness, perceived stress, serum cortisol and serum CRP.
Using a Randomized controlled study conducted in a large university in Jordan, 108 nursing students were randomly assigned to experimental and control groups equally. The experimental group participated in 5 30-minute weekly sessions of mindfulness meditation. Trait mindfulness, perceived stress, serum cortisol, and CRP were measured at baseline and end of intervention.
Read the detailed description
Introduction Like nursing students in other countries, nursing students in Jordan have reported high stress, influencing students' health, academic performance, attrition, and ability to care for patients and themselves. Previous studies have shown that stress can negatively impact the body. Specifically, the immune system can be negatively impacted by the activation of the hypothalamic-pituitary-adrenal (HPA) system (e.g. cortisol). Elevated cortisol increases the release of pro-inflammatory factors such as C-reactive protein (CRP), found to be associated with a variety of chronic illnesses. Mindfulness meditation is a mind-body therapy that has been gaining increasing attention in the recent literature and has demonstrated promising results across different populations and settings. In Jordan, there is a lack of evidence related to the effectiveness of mindfulness meditation on stress and its physiological indices such as cortisol and CRP in Jordanian people generally and nursing students specifically. Thus, the aim was to examine the effects of three of such intervention on perceived stress (MM) on Trait mindfulness, perceived stress, cortisol, and CRP in Jordanian nursing students.
Participants and Setting The study sample included undergraduate nursing students who were selected using convenience sampling from Jordan University of Science and Technology (JUST).
Sample Size Calculation G* Power software 3.1 was used to calculate the required sample size, given a MANOVA test, an alpha of .05, power of 0.95, number of dependent variables of 4, number of groups of 2, and effect size of 0.25. A sample size of 80 was calculated, and an attrition rate of 35% was added based on a previous study with variables similar to those of the present study. Therefore, this resulted in a final total sample size of 108 participants.
Procedure First, approval from the institutional review board at JUST was obtained. After obtaining permission from the dean of the nursing college at JUST and the students' instructors, the PI visited the students in their classrooms. After the students' lecture had finished, the PI made an announcement explaining the study title and objectives and asked any students who were interested in participating to contact him either on the phone number assigned for the purposes of the study or via email. The PI arranged an initial meeting to meet with students who were interested in participating, which was to be held on another day in a private room at the university. At this meeting, the PI informed the students of the study objectives, risks, and benefits, in addition to answering the students' questions and assuring them that all collected data would be kept confidential. The students were also assured that they had the full right to refuse or discontinue participation at any time and that such refusal or discontinuation would not affect their academic achievement in any way. At the same meeting, informed consent was obtained from participants who agreed to participate and who met the eligibility criteria. After that, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study. Finally, the dates and times of the sessions were determined.
In the 2-hour educational session, baseline measurements of the study variables were taken. Then, the PI delivered a PowerPoint presentation for the participants in each subgroup, as previously explained. At the end of the workshop, to avoid experimental contamination, the participants in each experimental group were asked not to share any information related to the intervention with the participants in the control group.
The actual training sessions were introduced to the participants in the experimental groups by the PI based on the ABC relaxation theory's guidelines and protocols. Based on the ABC Relaxation Theory, at least two, and preferably five, weekly sessions of actual mind-body training should be provided to evoke relaxation and optimize health. The sessions were held in a private, quiet, comfortable, and spacious room at the university. As previously mentioned, the dependent variables were measured twice, at baseline and at the end of the intervention (i.e., In the next morning after the 5th session).
Various strategies were followed to decrease measurement errors that could potentially be affected by variations in the data collection procedure. For example, filling out the questionnaire may be stressful for some subjects, hence influencing the objective measures. Therefore, the self-report measures were completed after the physical measures were taken. Also, all of the study measures in the intervention and control groups were taken in similar conditions, including similar room temperature and environment. In addition, quiet environments were maintained, with a "Do Not Disturb" sign placed on the doors of the rooms during the interventions and data collection.
Statistical Analysis Statistical analysis was conducted using SPSS software (version 25). Descriptive statistics were used to describe the sample. The sample and study variables were described by measures of central tendency and dispersion appropriate to the level of measurement. Initial independent t-tests and Chi-squared tests were conducted to ensure that the randomization across the covariates was successful, and one-way MANOVA was used to test the study hypotheses. Post hoc one-way ANOVAs were run to examine if there were significant differences in each of the dependent variables between the study groups. Due to multiple testing, the p-value was adjusted by dividing the p value of .05 by 4 (i.e., the number of dependent variables), with a level of .0125 considered as the level of significance for the ANOVA tests.
- Conditions
- Stress Reaction, Nurse's Role
- Being tested
- Mindfulness meditation
- Keywords
- Nursing students, Stress, C-reactive proteins, Cortisol, Mindfulness meditation
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
similar to the information included in arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Experimental group receiving mindfulness meditation | Experimental | The ABC standardized version of mindfulness meditation was used, which includes 5 30-minute weekly sessions of mindfulness meditation. An additional 3-hour educational workshop about the rationale and procedures of intervention was provided before the actual training sessions. The intervention was supervised by PI is an experienced practitioner who received stress-management training at the Psychology Department at Kent State University The participants were asked to sit upright in a comfortable position, place their feet on the floor, and quietly observe and reflect on internal and external stimuli such as breathing, thought, feeling, physical sensation, and sound, without reactions, judgments, or evaluations. Receives: Behavioral: Mindfulness meditation |
| Control group | No intervention | Each of the control group subgroups had 10 participants. The participants were instructed to sit with their eyes closed and relax during the intervention sessions, in order to control for the nonspecific effects of trainer interaction, social interaction, attention, environment, time, and closed eyes. The timings of the control group interventions were similar to those of the experimental groups, whereby if a given experimental group intervention lasted for 30 minutes, the control group participants would be asked to sit with their eyes closed and relax for 30 minutes also. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trait Mindfulness
Trait mindfulness was measured using the Arabic version of the Mindful Attention Awareness Scale (MAAS) (28), which is a one-dimensional scale that includes 15 items measured on a six-point Likert-type scale ranging from 1 (almost always) to 6 (almost never). The total possible score ranges between 15 and 90, with higher scores indicating higher levels of trait mindfulness. The original scale has been shown to have strong psychometric properties when validated among college students (28). Further, the Arabic version of this scale has been shown to have excellent internal consistency and convergent validity for use among Arab populations (29). In the current study, the Cronbach's alpha for the Arabic version of the MAAS was .79, indicating good internal consistency.
Measured: 6 weeks
Perceived stress
The Perceived Stress Scale (PSS) (30) is used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded). The scale comprises 10 items which are measured on a 5-point Likert scale (0=never, 4= very often) and which are relatively free of content specific to any subpopulation group. The total possible score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress (30). The PSS has been validated for use among college students, with internal consistency coefficients ranging from .84 to 36 and a test-retest reliability of .85 (30). The Arabic version of the PSS, which was used in the present study, has been shown to have adequate reliability and validity and is considered a suitable instrument for assessing perceived stress among Arab populations (31). In the current study, the Cronbach's alpha for the Arabic version of the PSS was .81, indicating good internal consistency.
Measured: 6 weeks
Serum cortisol
The ELISA method has been found to be accurate, sensitive, specific, and precise in terms of determining the plasma concentration of cortisol (32). In the current study, the ELISA kit and protocols were used to analyze the blood sample for the serum cortisol (CEA462Ge) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).
Measured: 6 weeks
Serum CRP
The ELISA kit and protocols were used to analyze the blood sample for the serum CRP (Cat no: SEA821Hu) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Oct 2020
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled Trial (pretest-posttests, two-group, randomized design)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Najjem Alhawatmeh, Jordan University of Science and Technology
- Investigators
- Hossam Alhawatmeh, PhD, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099224
- Sponsor's protocol ID
- 377/2019
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster K, Roche M, Giandinoto JA, Platania-Phung C, Furness T. Mental health matters: A cross-sectional study of mental health nurses' health-related quality of life and work-related stressors. Int J Ment Health Nurs. 2021 Jun;30(3):624-634. doi: 10.1111/inm.12823. Epub 2020 Dec 5.
PubMed 33280229Al-Zayyat AS, Al-Gamal E. Perceived stress and coping strategies among Jordanian nursing students during clinical practice in psychiatric/mental health courses. Int J Ment Health Nurs. 2014 Aug;23(4):326-35. doi: 10.1111/inm.12054. Epub 2013 Dec 25.
PubMed 24372812Labrague LJ, McEnroe-Petitte DM, De Los Santos JAA, Edet OB. Examining stress perceptions and coping strategies among Saudi nursing students: A systematic review. Nurse Educ Today. 2018 Jun;65:192-200. doi: 10.1016/j.nedt.2018.03.012. Epub 2018 Mar 21.
PubMed 29602137Chaabane S, Chaabna K, Bhagat S, Abraham A, Doraiswamy S, Mamtani R, Cheema S. Perceived stress, stressors, and coping strategies among nursing students in the Middle East and North Africa: an overview of systematic reviews. Syst Rev. 2021 May 5;10(1):136. doi: 10.1186/s13643-021-01691-9.
PubMed 33952346Kinlein 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.
PubMed 31863788Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
PubMed 33884400Sousa GM, Lima-Araujo GL, Araujo DB, Sousa MBC. Brief mindfulness-based training and mindfulness trait attenuate psychological stress in university students: a randomized controlled trial. BMC Psychol. 2021 Feb 1;9(1):21. doi: 10.1186/s40359-021-00520-x.
PubMed 33526085Bottaccioli AG, Bottaccioli F, Carosella A, Cofini V, Muzi P, Bologna M. Psychoneuroendocrinoimmunology-based meditation (PNEIMED) training reduces salivary cortisol under basal and stressful conditions in healthy university students: Results of a randomized controlled study. Explore (NY). 2020 May-Jun;16(3):189-198. doi: 10.1016/j.explore.2019.10.006. Epub 2019 Nov 14.
PubMed 31982328Brown 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. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Rayan A, Ahmad M. The psychometric properties of the mindful attention awareness scale among Arab parents of children with autism spectrum disorder. Arch Psychiatr Nurs. 2018 Jun;32(3):444-448. doi: 10.1016/j.apnu.2018.01.001. Epub 2018 Jan 3.
PubMed 29784228Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Almadi T, Cathers I, Hamdan Mansour AM, Chow CM. An Arabic version of the perceived stress scale: translation and validation study. Int J Nurs Stud. 2012 Jan;49(1):84-9. doi: 10.1016/j.ijnurstu.2011.07.012. Epub 2011 Aug 17.
PubMed 21851941Levine A, Zagoory-Sharon O, Feldman R, Lewis JG, Weller A. Measuring cortisol in human psychobiological studies. Physiol Behav. 2007 Jan 30;90(1):43-53. doi: 10.1016/j.physbeh.2006.08.025. Epub 2006 Oct 19.
PubMed 17055006Fetzer SJ. Reducing venipuncture and intravenous insertion pain with eutectic mixture of local anesthetic: a meta-analysis. Nurs Res. 2002 Mar-Apr;51(2):119-24. doi: 10.1097/00006199-200203000-00008.
PubMed 11984382Smith JC. Relaxation, meditation, & mindfulness: A mental health practitioner's guide to new and traditional approaches. Springer Publishing Company; 2005 Mar 4.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Meditation on Psychoneuroendocrinoimmunology in Nursing Students
- ClinicalTrials.gov ID
- NCT05099224
- Acronym / sponsor ID
- 377/2019
- Conditions
- Stress Reaction, Nurse's Role
- Keywords
- Nursing students, Stress, C-reactive proteins, Cortisol, Mindfulness meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mindfulness meditation was used to reduce stress and its responses such as cortisol and C-reactive protein (CRP) among healthy and ill individuals in various cultures, but their effects have not yet been studied among Jordanian nursing students, experienced tremendous stress. Thus, the purpose of study was to examine the effects of three of such intervention on perceived stress (MM) on Trait mindfulness, perceived stress, cortisol, and CRP in Jordanian nursing students. The hypothesis was " mindfulness meditation will improve trait mindfulness, perceived stress, serum cortisol and serum CRP.
Using a Randomized controlled study conducted in a large university in Jordan, 108 nursing students were randomly assigned to experimental and control groups equally. The experimental group participated in 5 30-minute weekly sessions of mindfulness meditation. Trait mindfulness, perceived stress, serum cortisol, and CRP were measured at baseline and end of intervention.
Detailed description
Introduction Like nursing students in other countries, nursing students in Jordan have reported high stress, influencing students' health, academic performance, attrition, and ability to care for patients and themselves. Previous studies have shown that stress can negatively impact the body. Specifically, the immune system can be negatively impacted by the activation of the hypothalamic-pituitary-adrenal (HPA) system (e.g. cortisol). Elevated cortisol increases the release of pro-inflammatory factors such as C-reactive protein (CRP), found to be associated with a variety of chronic illnesses. Mindfulness meditation is a mind-body therapy that has been gaining increasing attention in the recent literature and has demonstrated promising results across different populations and settings. In Jordan, there is a lack of evidence related to the effectiveness of mindfulness meditation on stress and its physiological indices such as cortisol and CRP in Jordanian people generally and nursing students specifically. Thus, the aim was to examine the effects of three of such intervention on perceived stress (MM) on Trait mindfulness, perceived stress, cortisol, and CRP in Jordanian nursing students.
Participants and Setting The study sample included undergraduate nursing students who were selected using convenience sampling from Jordan University of Science and Technology (JUST).
Sample Size Calculation G* Power software 3.1 was used to calculate the required sample size, given a MANOVA test, an alpha of .05, power of 0.95, number of dependent variables of 4, number of groups of 2, and effect size of 0.25. A sample size of 80 was calculated, and an attrition rate of 35% was added based on a previous study with variables similar to those of the present study. Therefore, this resulted in a final total sample size of 108 participants.
Procedure First, approval from the institutional review board at JUST was obtained. After obtaining permission from the dean of the nursing college at JUST and the students' instructors, the PI visited the students in their classrooms. After the students' lecture had finished, the PI made an announcement explaining the study title and objectives and asked any students who were interested in participating to contact him either on the phone number assigned for the purposes of the study or via email. The PI arranged an initial meeting to meet with students who were interested in participating, which was to be held on another day in a private room at the university. At this meeting, the PI informed the students of the study objectives, risks, and benefits, in addition to answering the students' questions and assuring them that all collected data would be kept confidential. The students were also assured that they had the full right to refuse or discontinue participation at any time and that such refusal or discontinuation would not affect their academic achievement in any way. At the same meeting, informed consent was obtained from participants who agreed to participate and who met the eligibility criteria. After that, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study. Finally, the dates and times of the sessions were determined.
In the 2-hour educational session, baseline measurements of the study variables were taken. Then, the PI delivered a PowerPoint presentation for the participants in each subgroup, as previously explained. At the end of the workshop, to avoid experimental contamination, the participants in each experimental group were asked not to share any information related to the intervention with the participants in the control group.
The actual training sessions were introduced to the participants in the experimental groups by the PI based on the ABC relaxation theory's guidelines and protocols. Based on the ABC Relaxation Theory, at least two, and preferably five, weekly sessions of actual mind-body training should be provided to evoke relaxation and optimize health. The sessions were held in a private, quiet, comfortable, and spacious room at the university. As previously mentioned, the dependent variables were measured twice, at baseline and at the end of the intervention (i.e., In the next morning after the 5th session).
Various strategies were followed to decrease measurement errors that could potentially be affected by variations in the data collection procedure. For example, filling out the questionnaire may be stressful for some subjects, hence influencing the objective measures. Therefore, the self-report measures were completed after the physical measures were taken. Also, all of the study measures in the intervention and control groups were taken in similar conditions, including similar room temperature and environment. In addition, quiet environments were maintained, with a "Do Not Disturb" sign placed on the doors of the rooms during the interventions and data collection.
Statistical Analysis Statistical analysis was conducted using SPSS software (version 25). Descriptive statistics were used to describe the sample. The sample and study variables were described by measures of central tendency and dispersion appropriate to the level of measurement. Initial independent t-tests and Chi-squared tests were conducted to ensure that the randomization across the covariates was successful, and one-way MANOVA was used to test the study hypotheses. Post hoc one-way ANOVAs were run to examine if there were significant differences in each of the dependent variables between the study groups. Due to multiple testing, the p-value was adjusted by dividing the p value of .05 by 4 (i.e., the number of dependent variables), with a level of .0125 considered as the level of significance for the ANOVA tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled Trial (pretest-posttests, two-group, randomized design)
| Arm | Type | Receives |
|---|---|---|
| Experimental group receiving mindfulness meditation | Experimental | Behavioral: Mindfulness meditationThe ABC standardized version of mindfulness meditation was used, which includes 5 30-minute weekly sessions of mindfulness meditation. An additional 3-hour educational workshop about the rationale and procedures of intervention was provided before the actual training sessions. The intervention was supervised by PI is an experienced practitioner who received stress-management training at the Psychology Department at Kent State University The participants were asked to sit upright in a comfortable position, place their feet on the floor, and quietly observe and reflect on internal and external stimuli such as breathing, thought, feeling, physical sensation, and sound, without reactions, judgments, or evaluations. |
| Control group | No intervention | –Each of the control group subgroups had 10 participants. The participants were instructed to sit with their eyes closed and relax during the intervention sessions, in order to control for the nonspecific effects of trainer interaction, social interaction, attention, environment, time, and closed eyes. The timings of the control group interventions were similar to those of the experimental groups, whereby if a given experimental group intervention lasted for 30 minutes, the control group participants would be asked to sit with their eyes closed and relax for 30 minutes also. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study sample included undergraduate nursing students who were aged 18 years or over and taking a clinical course
Key exclusion criteria (1 listed)
- Students were excluded if they were practicing any type of relaxation techniques or taking hypnotics, sedatives, anxiolytics, anti-depressants, or anti-hypertensive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationsimilar to the information included in arm/group descriptions | Behavioural | Experimental group receiving mindfulness meditation |
Primary outcome
Trait Mindfulness
Time frame: 6 weeks
Trait mindfulness was measured using the Arabic version of the Mindful Attention Awareness Scale (MAAS) (28), which is a one-dimensional scale that includes 15 items measured on a six-point Likert-type scale ranging from 1 (almost always) to 6 (almost never). The total possible score ranges between 15 and 90, with higher scores indicating higher levels of trait mindfulness. The original scale has been shown to have strong psychometric properties when validated among college students (28). Further, the Arabic version of this scale has been shown to have excellent internal consistency and convergent validity for use among Arab populations (29). In the current study, the Cronbach's alpha for the Arabic version of the MAAS was .79, indicating good internal consistency.
Perceived stress
Time frame: 6 weeks
The Perceived Stress Scale (PSS) (30) is used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, and overloaded). The scale comprises 10 items which are measured on a 5-point Likert scale (0=never, 4= very often) and which are relatively free of content specific to any subpopulation group. The total possible score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress (30). The PSS has been validated for use among college students, with internal consistency coefficients ranging from .84 to 36 and a test-retest reliability of .85 (30). The Arabic version of the PSS, which was used in the present study, has been shown to have adequate reliability and validity and is considered a suitable instrument for assessing perceived stress among Arab populations (31). In the current study, the Cronbach's alpha for the Arabic version of the PSS was .81, indicating good internal consistency.
Serum cortisol
Time frame: 6 weeks
The ELISA method has been found to be accurate, sensitive, specific, and precise in terms of determining the plasma concentration of cortisol (32). In the current study, the ELISA kit and protocols were used to analyze the blood sample for the serum cortisol (CEA462Ge) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).
Serum CRP
Time frame: 6 weeks
The ELISA kit and protocols were used to analyze the blood sample for the serum CRP (Cat no: SEA821Hu) . Three research assistants with at least 10 years of experience collected 10 mL blood samples via venipuncture both at baseline and next day morning after the last session, between 8:30-9:30 AM. The results were read using a SYNERGY (HTZ) multi-mode reader, connected to a computer which showed each reading value. The participants were asked to avoid caffeine consumption on the days of data collection. To decrease venipuncture-related pain during blood sampling, the EMLA cream was used, as it has been found effective in decreasing venipuncture-related pain among different populations (33).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 33280229Foster K, Roche M, Giandinoto JA, Platania-Phung C, Furness T. Mental health matters: A cross-sectional study of mental health nurses' health-related quality of life and work-related stressors. Int J Ment Health Nurs. 2021 Jun;30(3):624-634. doi: 10.1111/inm.12823. Epub 2020 Dec 5.
- Background: PubMed 24372812Al-Zayyat AS, Al-Gamal E. Perceived stress and coping strategies among Jordanian nursing students during clinical practice in psychiatric/mental health courses. Int J Ment Health Nurs. 2014 Aug;23(4):326-35. doi: 10.1111/inm.12054. Epub 2013 Dec 25.
- Background: PubMed 29602137Labrague LJ, McEnroe-Petitte DM, De Los Santos JAA, Edet OB. Examining stress perceptions and coping strategies among Saudi nursing students: A systematic review. Nurse Educ Today. 2018 Jun;65:192-200. doi: 10.1016/j.nedt.2018.03.012. Epub 2018 Mar 21.
- Background: PubMed 33952346Chaabane S, Chaabna K, Bhagat S, Abraham A, Doraiswamy S, Mamtani R, Cheema S. Perceived stress, stressors, and coping strategies among nursing students in the Middle East and North Africa: an overview of systematic reviews. Syst Rev. 2021 May 5;10(1):136. doi: 10.1186/s13643-021-01691-9.
- Background: PubMed 31863788Kinlein 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.
- Background: PubMed 33884400Zhang D, Lee EKP, Mak ECW, Ho CY, Wong SYS. Mindfulness-based interventions: an overall review. Br Med Bull. 2021 Jun 10;138(1):41-57. doi: 10.1093/bmb/ldab005.
- Background: PubMed 33526085Sousa GM, Lima-Araujo GL, Araujo DB, Sousa MBC. Brief mindfulness-based training and mindfulness trait attenuate psychological stress in university students: a randomized controlled trial. BMC Psychol. 2021 Feb 1;9(1):21. doi: 10.1186/s40359-021-00520-x.
- Background: PubMed 31982328Bottaccioli AG, Bottaccioli F, Carosella A, Cofini V, Muzi P, Bologna M. Psychoneuroendocrinoimmunology-based meditation (PNEIMED) training reduces salivary cortisol under basal and stressful conditions in healthy university students: Results of a randomized controlled study. Explore (NY). 2020 May-Jun;16(3):189-198. doi: 10.1016/j.explore.2019.10.006. Epub 2019 Nov 14.
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- Background: PubMed 29784228Rayan A, Ahmad M. The psychometric properties of the mindful attention awareness scale among Arab parents of children with autism spectrum disorder. Arch Psychiatr Nurs. 2018 Jun;32(3):444-448. doi: 10.1016/j.apnu.2018.01.001. Epub 2018 Jan 3.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossam Alhawatmeh, PhD principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Stress Reaction and Nurse's Role, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trait Mindfulness (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099224, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.