StressNCT06405789
The Effect of Yoga on Mindfulness and Perceived Stress
A study testing yoga practice in people with Stress, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students. A randomized controlled study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The required institutional permission and ethics committee approval was received. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- yoga practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2019to 30 Jan 2020
- 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
- being a first-year class nursing student
- older than 18 ages
- volunteering to participate
- giving consent
Who cannot join
- with a disability to practice yoga, hearing, and visual impairment
- unwillingness to continue participating in the study and school absenteeism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Democracy University
Izmir, Ege Bölgesi, 35560
About this study
Official title: The Effect of Yoga on Mindfulness and Perceived Stress Level in Nursing Students
This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students. A randomized controlled study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The required institutional permission and ethics committee approval was received. The study participants were 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week. The control group did not practice yoga.
Read the detailed description
This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received.
The study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The study consisted of 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week face to face. The control group did not practice yoga. The data were collected using "Personnel data form", "Mindful Attention Awareness Scale", "Perceived Stress Scale". The data were collected from the students using the online survey. For data analysis, descriptive statistics, paired sample t test, independent t, Pearson chi-square test were used. At the end of the study, the same yoga session was held with the students in the control group.
- Conditions
- Stress
- Being tested
- yoga practice
- Keywords
- yoga, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga practiceOther
The researcher has a yoga certificate before the study. The intervention group participated in 15 weeks of yoga/awareness activities led by the researcher. The yoga curriculum for the use of yoga in the classroom had been previously studied with nursing students and permission was obtained for its use in this study [11]. The course content consists of 1.5 hours/per week (theoretical: 30 minutes; practical: 60 minutes) Each yoga session includes 5 minutes of breathing (pranayama) and warming up, 40 minutes of postures (asanas), 5 minutes of breathing (pranayama), 5 minutes of corpse pose (shavasana).In addition, to develop mindfulness, after the class, students were offered daily practices that enable a mindfulness-based approach to life events. The students participated in activities such as yoga practice, breathing and relaxation exercises, meditation practices with instructor notes and resources.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The intervention group participated in 15 weeks of yoga/awareness activities led by the researcher. The yoga curriculum for the use of yoga in the classroom had been previously studied with nursing students and permission was obtained for its use in this study. The course content consists of 1.5 hours/per week (theoretical: 30 minutes; practical: 60 minutes) Each yoga session includes 5 minutes of breathing (pranayama) and warming up, 40 minutes of postures (asanas), 5 minutes of breathing (pranayama), 5 minutes of corpse pose (shavasana).In addition, to develop mindfulness, after the class, students were offered daily practices that enable a mindfulness-based approach to life events. The students participated in activities such as yoga practice, breathing and relaxation exercises, meditation practices with instructor notes and resources. Receives: Other: yoga practice |
| control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindful Attention Awareness Scale
The scale consists of fifteen items and consists of one dimension. The 6-point Likert-type scale has a rating scale of "1=almost always, 2=most of the time, 3=sometimes, 4=rarely, 5=very rarely, 6=almost never". While this scale provides a single total score, high scores indicate high levels of mindfulness
Measured: 15 weeks
Perceived Stress Scale (PSS)
The PSS, which consists of a total of 10 items, was developed to measure the extent to which certain situations in a person's life are perceived as stressful. Participants rated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". While The scores of the PSS-10 range from 0 to 40 and from 0 to 16. A high score indicates an increased perception of stress
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start30 Sep 2019
- Primary completion20 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Single group
- Model description
- A randomized controlled design with intervention and control groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özüm Erkin, Izmir Democracy University
- Investigators
- özüm erkin, Ph.D, Principal investigator, İzmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405789
- Sponsor's protocol ID
- IDU-SBF-ÖE-01
- Status last verified
- Sep 2024
- First submitted
- 4 May 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Mindfulness and Perceived Stress Level in Nursing Students
- ClinicalTrials.gov ID
- NCT06405789
- Acronym / sponsor ID
- IDU-SBF-ÖE-01
- Conditions
- Stress
- Keywords
- yoga, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 8 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.
This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students. A randomized controlled study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The required institutional permission and ethics committee approval was received. The study participants were 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week. The control group did not practice yoga.
Detailed description
This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received.
The study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The study consisted of 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week face to face. The control group did not practice yoga. The data were collected using "Personnel data form", "Mindful Attention Awareness Scale", "Perceived Stress Scale". The data were collected from the students using the online survey. For data analysis, descriptive statistics, paired sample t test, independent t, Pearson chi-square test were used. At the end of the study, the same yoga session was held with the students in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled design with intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: yoga practiceThe intervention group participated in 15 weeks of yoga/awareness activities led by the researcher. The yoga curriculum for the use of yoga in the classroom had been previously studied with nursing students and permission was obtained for its use in this study. The course content consists of 1.5 hours/per week (theoretical: 30 minutes; practical: 60 minutes) Each yoga session includes 5 minutes of breathing (pranayama) and warming up, 40 minutes of postures (asanas), 5 minutes of breathing (pranayama), 5 minutes of corpse pose (shavasana).In addition, to develop mindfulness, after the class, students were offered daily practices that enable a mindfulness-based approach to life events. The students participated in activities such as yoga practice, breathing and relaxation exercises, meditation practices with instructor notes and resources. |
| control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- being a first-year class nursing student
- older than 18 ages
- volunteering to participate
- giving consent
Key exclusion criteria (2 listed)
- with a disability to practice yoga, hearing, and visual impairment
- unwillingness to continue participating in the study and school absenteeism
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 |
|---|---|---|
| yoga practiceThe researcher has a yoga certificate before the study. The intervention group participated in 15 weeks of yoga/awareness activities led by the researcher. The yoga curriculum for the use of yoga in the classroom had been previously studied with nursing students and permission was obtained for its use in this study [11]. The course content consists of 1.5 hours/per week (theoretical: 30 minutes; practical: 60 minutes) Each yoga session includes 5 minutes of breathing (pranayama) and warming up, 40 minutes of postures (asanas), 5 minutes of breathing (pranayama), 5 minutes of corpse pose (shavasana).In addition, to develop mindfulness, after the class, students were offered daily practices that enable a mindfulness-based approach to life events. The students participated in activities such as yoga practice, breathing and relaxation exercises, meditation practices with instructor notes and resources. | Other | intervention |
Primary outcome
Mindful Attention Awareness Scale
Time frame: 15 weeks
The scale consists of fifteen items and consists of one dimension. The 6-point Likert-type scale has a rating scale of "1=almost always, 2=most of the time, 3=sometimes, 4=rarely, 5=very rarely, 6=almost never". While this scale provides a single total score, high scores indicate high levels of mindfulness
Perceived Stress Scale (PSS)
Time frame: 15 weeks
The PSS, which consists of a total of 10 items, was developed to measure the extent to which certain situations in a person's life are perceived as stressful. Participants rated each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". While The scores of the PSS-10 range from 0 to 40 and from 0 to 16. A high score indicates an increased perception of stress
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 2 Oct 2024.
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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.
özüm erkin, Ph.D principal investigator
İzmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga practice in people with Stress, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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 2 Oct 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 Turkey (Türkiye). 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?
Mindful Attention Awareness Scale (time frame: 15 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?
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 2 Oct 2024.