Psychological Well-BeingNCT06401252
Mindfulness for Nurses' Psychological Health
A study testing Mindfulness-based intervention in people with Psychological Well-Being and Nurse's Role, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
Background: Nurses who worked with patients with COVID-19 in hospitals have experienced several threatening and challenging situations, negatively affecting psychological health. M-health-based mindfulness-based interventions were found to improve psychological health in various populations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being, Nurse's Role
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteJordan
- Study dates
- 30 Jan 2022to 1 Apr 2024
- 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
- Nurses taking care patients with COVID-19 in the King Abdullah University hospital (KAUH) who were aged at least 21 years old
- had smart phones
Who cannot join
- Participants who had psychological therapies or medications
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan University of Science and Technology
Irbid, None Selected, 22110
About this study
Official title: Effects Of Mindfulness-Based Intervention on Psychological Health Among Jordanian Nurses Taking Care Patients With Covid-19
Background: Nurses who worked with patients with COVID-19 in hospitals have experienced several threatening and challenging situations, negatively affecting psychological health. M-health-based mindfulness-based interventions were found to improve psychological health in various populations.
Aim: The purpose of this study is to assess the effectiveness of a m-Health-based mindfulness-based intervention on anxiety, depression, stress among Jordanian registered nurses taking care of COVID-19 patients.
Methodology: The study was conducted using a pretest post-test randomized controlled design. One hundred and two nurses were recruited from a Jordanian Hospital and randomly distributed into experimental group (n=51) and control group (n= 51). The study data were collected using a self-report questionnaire working in the King Abdullah University hospital at baseline and at the end of intervention. For five weeks, the experimental group had five individual 30-minute MBI sessions. An audio-based MBI that was given to them via the WhatsApp served as the research intervention. A self-report questionnaire was used to collect the study data as follows: 1) demographic characteristics and 2) Mindful Attention Awareness, and 3) Scale the Depression, Anxiety, and Stress Scale (DASS-21). The study outcomes were measured at baseline and at the end of the intervention. Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26.
Read the detailed description
Coronavirus Disease 2019 (COVID-19), first reported in Wuhan China, has been described as the first pandemic contributed to a coronavirus that has drawn intense attention worldwide. Up to April 11th, 2020, at least 381 diagnosed cases and 7 deaths have been reported in Jordan (Jordanian Health Ministry, 2020). Facing this critical situation, nurses are struggling on the front line to manage patients with COVID-19, placing them at risk of contracting the infectious disease (World Health Organization (WHO), 2020).
Like other countries, health care providers in Jordan account for a significant share of their Covid-19 cases (Jordanian Health Ministry, 2020). Although Jordanian government has undertaken much efforts to provide healthcare providers with personal protective equipment and immunization to avoid contracting the disease, their psychological well-being, like in other countries, have been disregarded (Duan, \& Zhu, 2020; Huffington \& Williams, 2020). A combination of long shifts, understaffing, overwhelming workload, and lack of sleep may all contribute to stress and mental burden of these healthcare providers, compromising immune systems and make them more vulnerable to the infectious disease (Chen, et al., 2020; WHO, 2020). The psychological effect experienced by nurses during the COVID-19 pandemic was evident in the literature. Anxiety, stress, and depression were commonly reported by nurses during the COVID-19 pandemics (Pratiwi, et al., 2023) Nurses' health in hospital settings is the most important consideration for providing excellent patient care. To achieve the optimal outcomes for the patients and their families, it is required that nurses to be kept at the highest level of psychological health. Therefore, officials and those in charge of health institutions must find appropriate solutions to help nurses to cope with mental health problems. A possible solution to nurses' mental health problems may rest in promoting medical interventions such as mind- body interventions (Goyal, et al., 2014).
Mindfulness-based intervention (MBI) is one of the most popular mind-body therapy methods used recently in psychotherapy, which is strongly associated with promotion physical and psychological well-being, it is an effective method for reducing stress and improving health (Bartlett, et al., 2021). Pascoe et al. (2017) imagined it as a combination of five main components: act with awareness, internal observation and external experiences, being non-judgmental, description and labeling and not reacting to thoughts and feelings. Theoretically, practicing MBI develops mindfulness trait, and then relaxes the body and mind and helps reduce the response or reactivity to stressful situation, traumatic events and challenging experiences (Hofmann \& Gómez, 2017). Many researchers have pointed to the effectiveness of in-person mindfulness training programs in reducing nurses' stress, anxiety, and depression in general health settings (Ghawadra, et al. 2020; Green \& Kinchen, 2021; Lomas, et al. 2019; Ramachandran, et al. 2022; Sulosaari, et al. 2022).
Mindfulness-based intervention (MBI) as a Mind-body therapy, recently increasing its popularity in Jordan, are easily accessible, easy to learn and inexpensive (Yanyu, et al., 2020). For easily accessible and nonphysical contact training mode, they can be delivered quite efficiently by easy-to-carry electronic devices to healthcare providers (Kubo, et al., 2019; Wiseman, et al., 2018). M-Health-based intervention is an innovative approach of treatment delivery using mobile technologies such as cell phones (Kubo, et al., 2019). Mobile phones are widely used in Jordan, with the most Jordanians (95%) having a smart phone (Gazal, 2020). The widespread use of smart phones highlights their potential to deliver cost-effective mind-body therapies that can be easily integrated into the lives of busy healthcare providers who are unable to attend regular in-person training sessions (Kubo, et al., 2019; Wiseman, et al., 2018). It also provides a feasible and effective therapeutic way to optimize physical distancing during pandemics, which contributes to decrease the transmission of infection (Tukur et al., 2023) Although a wide array of research has been conducted examining the relationship between MBI and psychological health problems in different populations (McGee, et al., 2023), this study came as first study-to the best of research knowledge- to examine the effectiveness of m-health-based MBI on stress, anxiety, and depression among nurses taking care patients with COVID-19. Investigating the effects of MBI on psychological health in such nurses may contribute to the development of evidence-based methods and guidelines for enhancing the mental well-being of them during this unprecedented epidemic and may also enhance humanity's ability to respond to other emerging pandemics.
Design This was an experimental study using pretest post-test randomized controlled design.
3.2 Sample Nurses taking care patients with COVID-19 in the King Abdullah University hospital (KAUH) who were aged at least 21 years old, had smart phones, and were able to read and write in English, were included. KAUH designated by the Jordanian Ministry of Health as the main COVID-19 testing and isolation center in the country's north. Participants who had psychological therapies or medications were excluded.
Using G* Power software 3.1 (Faul et al., 2007), independent t-test, an alpha of 0.05, a power of 0.8, and a moderate effect size of 0.5, a sample size of 102 was generated.
The sample was distributed randomly into the experimental group (n=61) and the control group (n= 61).
3.4 Intervention The experimental group received five individuals 30-minute sessions of MBI for five weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by an experienced, certified mindfulness practitioner based on the Smith's (2005) protocol to guarantee greater adherence and consistent delivery of MBI. The audio recording of the MBI was evaluated and validated for the clarity of voice and the MBI content by two psychologists who are experts in MBI.
However, an instructional session, other than the five weekly sessions mentioned above, was first conducted by the certified mindfulness practitioner to explain the rationale and procedures of MBI including a demonstration of the entire MBI protocol for the participants in the experimental group. This practitioner was also present during the delivery of the five MBI sessions in the hospital to confirm and facilitate the administration of the MBI sessions and answer any participants' questions. In addition, the experimental groups' participants were encouraged to practice the intervention daily at home, but home-based practice was not mandatory. Through the WhatsApp group, daily reminders were sent to the participants in the experimental group to encourage them to practice at home. Diaries was used by the experimental group's participants to document the daily home-based practices. The participants in the experimental groups were encouraged not to share any information regarding the MBI with anyone during the study.
The theory-based program includes the ABC standardized versions of MBI (Smith, 2005), described as follows:
- The mindful mediators are asked to act as 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 19 stimuli. 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") (Smith, 2005).
- Participants in the control group were not asked to do anything during the study, except their traditional practices. However, the MBI was provided to them after the study.
3.5 Measurements The study data were collected using a self-report questionnaire at baseline and at the end of intervention. The participants were asked to complete the study self-report questionnaire, including three parts, as follows: 1) demographic characteristics, and 2) The Depression, Anxiety, and Stress Scale (DASS-21), and 3) Mindful attention Awareness Scale 3.5.1 Demographic and Health Characteristics The demographic and health characteristics included sex, marital status, religion, department, educational level, nursing experience (years), having chronic diseases, age, weight, monthly income, general health status, nutritional status, sleeping status.
3.5.2 The Depression, Anxiety, and Stress Scale (DASS-21) The Arabic DASS was used to measure depression, anxiety and stress in the current study (Lovibond \& Lovibond, 1995). The DASS-21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS subscales contains 7 items. Subjects were asked to use 4-point severity/frequency scales to rate the extent to which they had experienced each state. Scores for Depression, Anxiety and Stress were calculated by summing the scores for the relevant items, and then multiplying the summed scores by 2. The score range of each subscale is between 0.0 to 42. Higher scores of the three subscales indicate higher levels of those emotional states. The DASS has shown acceptable levels of validity and reliability in clinical and healthy populations (Lovibond \& Lovibond, 1995). The reliability and validity of Arabic version of DASS demonstrated acceptable reliability and validity of this tool (Alharbi et al. 2023). In Jordanian nursing students, the Cronbach's alphas for the stress, anxiety, and depression subscales were .73, .82, and .80 respectively (Alhawatmeh et al., 2022).
3.5.3. the Mindful Attention Awareness Scale (MAAS) was used to measure trait mindfulness. The MAAS is one-dimensional and comprises 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 scores indicating higher levels of trait mindfulness. The Arabic MAAS has been shown to have excellent internal consistency and convergent validity among an Arab population.
3.6 Data collection and Ethical consideration After getting the IRB approval, the hospital administrators were contacted by the study researchers to obtain approval for conducting the study. After approval, the nurses were contacted in person by one of the study researchers to explain the study purpose and procedure. If they agreed to participate, the nurses were asked to sign the consent form. After that, a study researcher who was not involved in the recruitment process and patient assessment randomly assigned the participants to the intervention group or the control group, using a simple 1:1 computer-generated sequence. Then, the schedule of practicing the MBI as the protocol described above was given for the participants in the experimental group, which was built based on their work schedule.
The study measurements were taken at the hospital by one of the study researchers (nurses) at baseline and at the end of the intervention. Also, all study measurements in the intervention and control groups were undertaken in the same conditions (i.e., same room temperature and environment) by a well-trained nurse who has a master's degree in nursing science.
3.7 Statistical Analysis Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26. Descriptive statistics were used to describe the study participants as appropriate. For instance, frequency and percentage were used to describe the categorical variables, while mean and standard deviation (SD) were used to describe the continuous variables. Also, the baseline statistical equivalence between the study groups on the dependent and sociodemographic variables was evaluated using independent t-tests. Dependent t-tests were used to examine if there were statistically significant changes between the pretest and posttest in each study group. Finally, independent t-tests were used to examine if there was a statistically significant difference between the experimental and control group at the end of the intervention.
- Conditions
- Psychological Well-Being, Nurse's Role
- Being tested
- Mindfulness-based intervention
- Keywords
- Mindfulness-based intervention, Stress, Depression, Anxiety, Nurses, COVID-19.
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
- The mindful mediators are asked to act as 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 19 stimuli. 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")
| Study group | Role | What they receive |
|---|---|---|
| Nurses receiving Mhealth-based mindfulness-based intervention | Experimental | The experimental group received five individuals 30-minute sessions of MBI for five weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by an experienced, certified mindfulness practitioner based on the Smith's (2005) protocol to guarantee greater adherence and consistent delivery of MBI. The audio recording of the MBI was evaluated and validated for the clarity of voice and the MBI content by two psychologists who are experts in MBI. Receives: Behavioral: Mindfulness-based intervention |
| Control group receiving traditional care | No intervention | Participants in the control group were not asked to do anything during the study, except their traditional practices. However, the MBI was provided to them after the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, anxiety, and Stress Scale (DASS-21)
The Arabic DASS was used to measure depression, anxiety and stress in the current study (Lovibond \& Lovibond, 1995). The DASS-21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS subscales contains 7 items. Subjects were asked to use 4-point severity/frequency scales to rate the extent to which they had experienced each state. The score range of each subscale is between 0.0 to 42. Higher scores of the three subscales indicate higher levels of those emotional states. The DASS has shown acceptable levels of validity and reliability in clinical and healthy populations (Lovibond \& Lovibond, 1995).
Measured: 6 weeks
Mindful Attention awareness Scale
Mindful Attention Awareness Scale (MAAS-15) was used to assess dispositional mindfulness (Brown \& Ryan, 2003).
The Arabic version of MASS-15 is a valid and reliable scale (Rayan \& Ahmad, 2018). 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 single-factor construct in MAAS structure and a Chronbach's alpha of 0.82 in university sample (Brown \& Ryan, 2003).
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 posted6 May 2024
- Study start30 Jan 2022
- Primary completion1 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Psychological Well-BeingStudies 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
- two-group, randomized controlled design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401252
- Sponsor's protocol ID
- 2022 / 147 / 32
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alhawatmeh H, Albataineh R, Abuhammad S. Differential effects of guided imagery and progressive muscle relaxation on physical and emotional symptoms in nursing students taking initial clinical training: A randomized clinical trial. Heliyon. 2022 Oct 19;8(10):e11147. doi: 10.1016/j.heliyon.2022.e11147. eCollection 2022 Oct.
PubMed 36311359Alharbi, F. S., Gangwani, S., Alsubaie, B. A., Osman, M., Alotaibi, F. S., Alsamman, D. D., & Mahfouz, T. A. O. (2023). Depression, Anxiety, and Stress among Adults in Saudi Arabia. Resmilitaris, 13(3), 1664-1672.
Al Ozairi A, Alsaeed D, Al-Ozairi E, Irshad M, Crane RS, Almoula A. Effectiveness of virtual mindfulness-based interventions on perceived anxiety and depression of physicians during the COVID-19 pandemic: A pre-post experimental study. Front Psychiatry. 2023 Jan 9;13:1089147. doi: 10.3389/fpsyt.2022.1089147. eCollection 2022.
PubMed 36699484Bartlett L, Buscot MJ, Bindoff A, Chambers R, Hassed C. Mindfulness Is Associated With Lower Stress and Higher Work Engagement in a Large Sample of MOOC Participants. Front Psychol. 2021 Sep 10;12:724126. doi: 10.3389/fpsyg.2021.724126. eCollection 2021.
PubMed 34566805Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
PubMed 32085839Duan L, Zhu G. Psychological interventions for people affected by the COVID-19 epidemic. Lancet Psychiatry. 2020 Apr;7(4):300-302. doi: 10.1016/S2215-0366(20)30073-0. Epub 2020 Feb 19. No abstract available.
PubMed 32085840Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Gazal, M. (2020). 95% of Jordanians own mobiles; 47% use the Internet. The Jordan Times. Retrieved from: http://www.jordantimes.com/news/local/95-jordanians-own-mobiles-47-use-internet
Ghawadra SF, Lim Abdullah K, Choo WY, Danaee M, Phang CK. The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial. J Nurs Manag. 2020 Jul;28(5):1088-1097. doi: 10.1111/jonm.13049. Epub 2020 Jun 24.
PubMed 32432795Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
PubMed 24395196Green AA, Kinchen EV. The Effects of Mindfulness Meditation on Stress and Burnout in Nurses. J Holist Nurs. 2021 Dec;39(4):356-368. doi: 10.1177/08980101211015818. Epub 2021 May 17.
PubMed 33998935Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.
PubMed 29080597Huffington, A & Williams, M. (2020). Combating coronavirus starts with keeping health workers well (commentary). Fortune. Retrieved from: https://fortune.com/2020/03/11/coronavirus-health-care-workers-well-being/
Jordanian Health Ministry. (2020). Coronavirus. Retrieved from: https://corona.moh.gov.jo/ar
Kubo A, Kurtovich E, McGinnis M, Aghaee S, Altschuler A, Quesenberry C Jr, Kolevska T, Avins AL. A Randomized Controlled Trial of mHealth Mindfulness Intervention for Cancer Patients and Informal Cancer Caregivers: A Feasibility Study Within an Integrated Health Care Delivery System. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419850634. doi: 10.1177/1534735419850634.
PubMed 31092044
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Mindfulness-Based Intervention on Psychological Health Among Jordanian Nurses Taking Care Patients With Covid-19
- ClinicalTrials.gov ID
- NCT06401252
- Acronym / sponsor ID
- 2022 / 147 / 32
- Conditions
- Psychological Well-Being, Nurse's Role
- Keywords
- Mindfulness-based intervention, Stress, Depression, Anxiety, Nurses, COVID-19.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 6 May 2024 (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.
Background: Nurses who worked with patients with COVID-19 in hospitals have experienced several threatening and challenging situations, negatively affecting psychological health. M-health-based mindfulness-based interventions were found to improve psychological health in various populations.
Aim: The purpose of this study is to assess the effectiveness of a m-Health-based mindfulness-based intervention on anxiety, depression, stress among Jordanian registered nurses taking care of COVID-19 patients.
Methodology: The study was conducted using a pretest post-test randomized controlled design. One hundred and two nurses were recruited from a Jordanian Hospital and randomly distributed into experimental group (n=51) and control group (n= 51). The study data were collected using a self-report questionnaire working in the King Abdullah University hospital at baseline and at the end of intervention. For five weeks, the experimental group had five individual 30-minute MBI sessions. An audio-based MBI that was given to them via the WhatsApp served as the research intervention. A self-report questionnaire was used to collect the study data as follows: 1) demographic characteristics and 2) Mindful Attention Awareness, and 3) Scale the Depression, Anxiety, and Stress Scale (DASS-21). The study outcomes were measured at baseline and at the end of the intervention. Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26.
Detailed description
Coronavirus Disease 2019 (COVID-19), first reported in Wuhan China, has been described as the first pandemic contributed to a coronavirus that has drawn intense attention worldwide. Up to April 11th, 2020, at least 381 diagnosed cases and 7 deaths have been reported in Jordan (Jordanian Health Ministry, 2020). Facing this critical situation, nurses are struggling on the front line to manage patients with COVID-19, placing them at risk of contracting the infectious disease (World Health Organization (WHO), 2020).
Like other countries, health care providers in Jordan account for a significant share of their Covid-19 cases (Jordanian Health Ministry, 2020). Although Jordanian government has undertaken much efforts to provide healthcare providers with personal protective equipment and immunization to avoid contracting the disease, their psychological well-being, like in other countries, have been disregarded (Duan, \& Zhu, 2020; Huffington \& Williams, 2020). A combination of long shifts, understaffing, overwhelming workload, and lack of sleep may all contribute to stress and mental burden of these healthcare providers, compromising immune systems and make them more vulnerable to the infectious disease (Chen, et al., 2020; WHO, 2020). The psychological effect experienced by nurses during the COVID-19 pandemic was evident in the literature. Anxiety, stress, and depression were commonly reported by nurses during the COVID-19 pandemics (Pratiwi, et al., 2023) Nurses' health in hospital settings is the most important consideration for providing excellent patient care. To achieve the optimal outcomes for the patients and their families, it is required that nurses to be kept at the highest level of psychological health. Therefore, officials and those in charge of health institutions must find appropriate solutions to help nurses to cope with mental health problems. A possible solution to nurses' mental health problems may rest in promoting medical interventions such as mind- body interventions (Goyal, et al., 2014).
Mindfulness-based intervention (MBI) is one of the most popular mind-body therapy methods used recently in psychotherapy, which is strongly associated with promotion physical and psychological well-being, it is an effective method for reducing stress and improving health (Bartlett, et al., 2021). Pascoe et al. (2017) imagined it as a combination of five main components: act with awareness, internal observation and external experiences, being non-judgmental, description and labeling and not reacting to thoughts and feelings. Theoretically, practicing MBI develops mindfulness trait, and then relaxes the body and mind and helps reduce the response or reactivity to stressful situation, traumatic events and challenging experiences (Hofmann \& Gómez, 2017). Many researchers have pointed to the effectiveness of in-person mindfulness training programs in reducing nurses' stress, anxiety, and depression in general health settings (Ghawadra, et al. 2020; Green \& Kinchen, 2021; Lomas, et al. 2019; Ramachandran, et al. 2022; Sulosaari, et al. 2022).
Mindfulness-based intervention (MBI) as a Mind-body therapy, recently increasing its popularity in Jordan, are easily accessible, easy to learn and inexpensive (Yanyu, et al., 2020). For easily accessible and nonphysical contact training mode, they can be delivered quite efficiently by easy-to-carry electronic devices to healthcare providers (Kubo, et al., 2019; Wiseman, et al., 2018). M-Health-based intervention is an innovative approach of treatment delivery using mobile technologies such as cell phones (Kubo, et al., 2019). Mobile phones are widely used in Jordan, with the most Jordanians (95%) having a smart phone (Gazal, 2020). The widespread use of smart phones highlights their potential to deliver cost-effective mind-body therapies that can be easily integrated into the lives of busy healthcare providers who are unable to attend regular in-person training sessions (Kubo, et al., 2019; Wiseman, et al., 2018). It also provides a feasible and effective therapeutic way to optimize physical distancing during pandemics, which contributes to decrease the transmission of infection (Tukur et al., 2023) Although a wide array of research has been conducted examining the relationship between MBI and psychological health problems in different populations (McGee, et al., 2023), this study came as first study-to the best of research knowledge- to examine the effectiveness of m-health-based MBI on stress, anxiety, and depression among nurses taking care patients with COVID-19. Investigating the effects of MBI on psychological health in such nurses may contribute to the development of evidence-based methods and guidelines for enhancing the mental well-being of them during this unprecedented epidemic and may also enhance humanity's ability to respond to other emerging pandemics.
Design This was an experimental study using pretest post-test randomized controlled design.
3.2 Sample Nurses taking care patients with COVID-19 in the King Abdullah University hospital (KAUH) who were aged at least 21 years old, had smart phones, and were able to read and write in English, were included. KAUH designated by the Jordanian Ministry of Health as the main COVID-19 testing and isolation center in the country's north. Participants who had psychological therapies or medications were excluded.
Using G* Power software 3.1 (Faul et al., 2007), independent t-test, an alpha of 0.05, a power of 0.8, and a moderate effect size of 0.5, a sample size of 102 was generated.
The sample was distributed randomly into the experimental group (n=61) and the control group (n= 61).
3.4 Intervention The experimental group received five individuals 30-minute sessions of MBI for five weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by an experienced, certified mindfulness practitioner based on the Smith's (2005) protocol to guarantee greater adherence and consistent delivery of MBI. The audio recording of the MBI was evaluated and validated for the clarity of voice and the MBI content by two psychologists who are experts in MBI.
However, an instructional session, other than the five weekly sessions mentioned above, was first conducted by the certified mindfulness practitioner to explain the rationale and procedures of MBI including a demonstration of the entire MBI protocol for the participants in the experimental group. This practitioner was also present during the delivery of the five MBI sessions in the hospital to confirm and facilitate the administration of the MBI sessions and answer any participants' questions. In addition, the experimental groups' participants were encouraged to practice the intervention daily at home, but home-based practice was not mandatory. Through the WhatsApp group, daily reminders were sent to the participants in the experimental group to encourage them to practice at home. Diaries was used by the experimental group's participants to document the daily home-based practices. The participants in the experimental groups were encouraged not to share any information regarding the MBI with anyone during the study.
The theory-based program includes the ABC standardized versions of MBI (Smith, 2005), described as follows:
- The mindful mediators are asked to act as 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 19 stimuli. 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") (Smith, 2005).
- Participants in the control group were not asked to do anything during the study, except their traditional practices. However, the MBI was provided to them after the study.
3.5 Measurements The study data were collected using a self-report questionnaire at baseline and at the end of intervention. The participants were asked to complete the study self-report questionnaire, including three parts, as follows: 1) demographic characteristics, and 2) The Depression, Anxiety, and Stress Scale (DASS-21), and 3) Mindful attention Awareness Scale 3.5.1 Demographic and Health Characteristics The demographic and health characteristics included sex, marital status, religion, department, educational level, nursing experience (years), having chronic diseases, age, weight, monthly income, general health status, nutritional status, sleeping status.
3.5.2 The Depression, Anxiety, and Stress Scale (DASS-21) The Arabic DASS was used to measure depression, anxiety and stress in the current study (Lovibond \& Lovibond, 1995). The DASS-21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS subscales contains 7 items. Subjects were asked to use 4-point severity/frequency scales to rate the extent to which they had experienced each state. Scores for Depression, Anxiety and Stress were calculated by summing the scores for the relevant items, and then multiplying the summed scores by 2. The score range of each subscale is between 0.0 to 42. Higher scores of the three subscales indicate higher levels of those emotional states. The DASS has shown acceptable levels of validity and reliability in clinical and healthy populations (Lovibond \& Lovibond, 1995). The reliability and validity of Arabic version of DASS demonstrated acceptable reliability and validity of this tool (Alharbi et al. 2023). In Jordanian nursing students, the Cronbach's alphas for the stress, anxiety, and depression subscales were .73, .82, and .80 respectively (Alhawatmeh et al., 2022).
3.5.3. the Mindful Attention Awareness Scale (MAAS) was used to measure trait mindfulness. The MAAS is one-dimensional and comprises 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 scores indicating higher levels of trait mindfulness. The Arabic MAAS has been shown to have excellent internal consistency and convergent validity among an Arab population.
3.6 Data collection and Ethical consideration After getting the IRB approval, the hospital administrators were contacted by the study researchers to obtain approval for conducting the study. After approval, the nurses were contacted in person by one of the study researchers to explain the study purpose and procedure. If they agreed to participate, the nurses were asked to sign the consent form. After that, a study researcher who was not involved in the recruitment process and patient assessment randomly assigned the participants to the intervention group or the control group, using a simple 1:1 computer-generated sequence. Then, the schedule of practicing the MBI as the protocol described above was given for the participants in the experimental group, which was built based on their work schedule.
The study measurements were taken at the hospital by one of the study researchers (nurses) at baseline and at the end of the intervention. Also, all study measurements in the intervention and control groups were undertaken in the same conditions (i.e., same room temperature and environment) by a well-trained nurse who has a master's degree in nursing science.
3.7 Statistical Analysis Data were analyzed using the Statistical Package for Social Science (SPSS), Version 26. Descriptive statistics were used to describe the study participants as appropriate. For instance, frequency and percentage were used to describe the categorical variables, while mean and standard deviation (SD) were used to describe the continuous variables. Also, the baseline statistical equivalence between the study groups on the dependent and sociodemographic variables was evaluated using independent t-tests. Dependent t-tests were used to examine if there were statistically significant changes between the pretest and posttest in each study group. Finally, independent t-tests were used to examine if there was a statistically significant difference between the experimental and control group at the end of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two-group, randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Nurses receiving Mhealth-based mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based interventionThe experimental group received five individuals 30-minute sessions of MBI for five weeks in a private and quiet room at the hospital, according to Smith's (2005) recommendation. The study intervention was an audio based MBI sent to them by the WhatsApp application. It is a free, self-paced program developed by an experienced, certified mindfulness practitioner based on the Smith's (2005) protocol to guarantee greater adherence and consistent delivery of MBI. The audio recording of the MBI was evaluated and validated for the clarity of voice and the MBI content by two psychologists who are experts in MBI. |
| Control group receiving traditional care | No intervention | –Participants in the control group were not asked to do anything during the study, except their traditional practices. However, the MBI was provided to them after the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses taking care patients with COVID-19 in the King Abdullah University hospital (KAUH) who were aged at least 21 years old
- had smart phones
Key exclusion criteria (1 listed)
- Participants who had psychological therapies or medications
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-based intervention• The mindful mediators are asked to act as 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 19 stimuli. 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") | Behavioural | Nurses receiving Mhealth-based mindfulness-based intervention |
Primary outcome
Depression, anxiety, and Stress Scale (DASS-21)
Time frame: 6 weeks
The Arabic DASS was used to measure depression, anxiety and stress in the current study (Lovibond \& Lovibond, 1995). The DASS-21 is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety and stress. Each of the three DASS subscales contains 7 items. Subjects were asked to use 4-point severity/frequency scales to rate the extent to which they had experienced each state. The score range of each subscale is between 0.0 to 42. Higher scores of the three subscales indicate higher levels of those emotional states. The DASS has shown acceptable levels of validity and reliability in clinical and healthy populations (Lovibond \& Lovibond, 1995).
Mindful Attention awareness Scale
Time frame: 6 weeks
Mindful Attention Awareness Scale (MAAS-15) was used to assess dispositional mindfulness (Brown \& Ryan, 2003). The Arabic version of MASS-15 is a valid and reliable scale (Rayan \& Ahmad, 2018). 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 single-factor construct in MAAS structure and a Chronbach's alpha of 0.82 in university sample (Brown \& Ryan, 2003).
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 6 May 2024.
- Background: PubMed 36311359Alhawatmeh H, Albataineh R, Abuhammad S. Differential effects of guided imagery and progressive muscle relaxation on physical and emotional symptoms in nursing students taking initial clinical training: A randomized clinical trial. Heliyon. 2022 Oct 19;8(10):e11147. doi: 10.1016/j.heliyon.2022.e11147. eCollection 2022 Oct.
- BackgroundAlharbi, F. S., Gangwani, S., Alsubaie, B. A., Osman, M., Alotaibi, F. S., Alsamman, D. D., & Mahfouz, T. A. O. (2023). Depression, Anxiety, and Stress among Adults in Saudi Arabia. Resmilitaris, 13(3), 1664-1672.
- Background: PubMed 36699484Al Ozairi A, Alsaeed D, Al-Ozairi E, Irshad M, Crane RS, Almoula A. Effectiveness of virtual mindfulness-based interventions on perceived anxiety and depression of physicians during the COVID-19 pandemic: A pre-post experimental study. Front Psychiatry. 2023 Jan 9;13:1089147. doi: 10.3389/fpsyt.2022.1089147. eCollection 2022.
- Background: PubMed 34566805Bartlett L, Buscot MJ, Bindoff A, Chambers R, Hassed C. Mindfulness Is Associated With Lower Stress and Higher Work Engagement in a Large Sample of MOOC Participants. Front Psychol. 2021 Sep 10;12:724126. doi: 10.3389/fpsyg.2021.724126. eCollection 2021.
- Background: PubMed 32085839Chen Q, Liang M, Li Y, Guo J, Fei D, Wang L, He L, Sheng C, Cai Y, Li X, Wang J, Zhang Z. Mental health care for medical staff in China during the COVID-19 outbreak. Lancet Psychiatry. 2020 Apr;7(4):e15-e16. doi: 10.1016/S2215-0366(20)30078-X. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 32085840Duan L, Zhu G. Psychological interventions for people affected by the COVID-19 epidemic. Lancet Psychiatry. 2020 Apr;7(4):300-302. doi: 10.1016/S2215-0366(20)30073-0. Epub 2020 Feb 19. No abstract available.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- BackgroundGazal, M. (2020). 95% of Jordanians own mobiles; 47% use the Internet. The Jordan Times. Retrieved from: http://www.jordantimes.com/news/local/95-jordanians-own-mobiles-47-use-internet
- Background: PubMed 32432795Ghawadra SF, Lim Abdullah K, Choo WY, Danaee M, Phang CK. The effect of mindfulness-based training on stress, anxiety, depression and job satisfaction among ward nurses: A randomized control trial. J Nurs Manag. 2020 Jul;28(5):1088-1097. doi: 10.1111/jonm.13049. Epub 2020 Jun 24.
- Background: PubMed 24395196Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
- Background: PubMed 33998935Green AA, Kinchen EV. The Effects of Mindfulness Meditation on Stress and Burnout in Nurses. J Holist Nurs. 2021 Dec;39(4):356-368. doi: 10.1177/08980101211015818. Epub 2021 May 17.
- Background: PubMed 29080597Hofmann SG, Gomez AF. Mindfulness-Based Interventions for Anxiety and Depression. Psychiatr Clin North Am. 2017 Dec;40(4):739-749. doi: 10.1016/j.psc.2017.08.008. Epub 2017 Sep 18.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-based intervention in people with Psychological Well-Being 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 2 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 6 May 2024. 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?
Depression, anxiety, and Stress Scale (DASS-21) (time frame: 6 weeks). The study lists 2 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 NCT06401252, which also lists 33 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 6 May 2024.