Intensive Care NursesNCT06518031
The Effects of Meditation on Stress and Fatigue
A study testing meditation in people with Intensive Care Nurses, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care Nurses
- What is being tested?
- meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2021to 30 Jan 2022
- 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
- Intensive care nurses with at least 1 year of experience in the intensive care unit.
- Nurses without chronic obstructive pulmonary disease, heart failure, asthma, or other conditions that could hinder breathing exercises.
- Nurses without hearing and communication issues, psychiatric diagnoses (e.g., major depression).
- Nurses who have not attended meditation, yoga, or breathing exercise classes in the past six months.
- Nurses willing to participate in the study were included in the sample.
Who cannot join
- Nurses who do not attend at least one of the meditation sessions conducted by the meditation expert.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses: A Randomized Controlled Trial
A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.
Read the detailed description
Participants in the intervention group underwent a meditation practice for 20 minutes, three times a week for six weeks. The meditation sessions were led by a meditation expert with 8 years of experience and conducted online via WhatsApp in a group setting. No intervention was given to the participants in the control group.
- Conditions
- Intensive Care Nurses
- Being tested
- meditation
- Keywords
- Meditation, Stress, Fatigue, Intensive Care Nurses, Well-being
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meditationOther
meditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | Meditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week Receives: Other: meditation |
| Control Group | No intervention | The research data were collected using a Personal Information Form prepared by the researchers containing introductory information about the nurses, the Perceived Stress Scale for stress, and the Fatigue Severity Scale for fatigue. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STRESS LEVELS
PERCEIVED STRESS SCALE
Measured: after 6 weeks
FATIGUE LEVELS
FATIGUE SEVERITY SCALE
Measured: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start19 Dec 2021
- Primary completion25 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care NursesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Gungor, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518031
- Sponsor's protocol ID
- OKUKAU
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Purpose and Scope: This IPD plan outlines how individual participant data from the study "The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses" will be shared and utilized. The data will be made available for verification of the study's findings and for further analysis by relevant researchers and scientific communities. Data Protection and Privacy: Participant data will be stored in compliance with national and international regulations to protect confidentiality. Data will only be shared for research purposes, ensuring participant identities are protected. Data Sharing Procedures: Data will be provided upon request to researchers and relevant institutions seeking to verify study results. Use of the data will be subject to approval by relevant ethics committees and for purposes of data sharing. Analysis Procedures: Data will be analyzed according to pre-established protocols, and findings will be presented in scientific reports. The methodology of analysis and i
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06518031
- Acronym / sponsor ID
- OKUKAU
- Conditions
- Intensive Care Nurses
- Keywords
- Meditation, Stress, Fatigue, Intensive Care Nurses, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 24 Jul 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.
A randomized controlled trial was conducted with nurses practicing meditation for six weeks, compared to a control group with no intervention. Stress and fatigue levels were measured using validated scales at baseline and post-intervention.
Detailed description
Participants in the intervention group underwent a meditation practice for 20 minutes, three times a week for six weeks. The meditation sessions were led by a meditation expert with 8 years of experience and conducted online via WhatsApp in a group setting. No intervention was given to the participants in the control group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Other: meditationMeditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week |
| Control Group | No intervention | –The research data were collected using a Personal Information Form prepared by the researchers containing introductory information about the nurses, the Perceived Stress Scale for stress, and the Fatigue Severity Scale for fatigue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intensive care nurses with at least 1 year of experience in the intensive care unit.
- Nurses without chronic obstructive pulmonary disease, heart failure, asthma, or other conditions that could hinder breathing exercises.
- Nurses without hearing and communication issues, psychiatric diagnoses (e.g., major depression).
- Nurses who have not attended meditation, yoga, or breathing exercise classes in the past six months.
- Nurses willing to participate in the study were included in the sample.
Key exclusion criteria (1 listed)
- Nurses who do not attend at least one of the meditation sessions conducted by the meditation expert.
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 |
|---|---|---|
| meditationmeditation practices were administered by the meditation expert for 6 weeks, three times a week for 20 minutes each session, totaling 60 minutes per week | Other | Meditation Group |
Primary outcome
STRESS LEVELS
Time frame: after 6 weeks
PERCEIVED STRESS SCALE
FATIGUE LEVELS
Time frame: after 6 weeks
FATIGUE SEVERITY SCALE
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 24 Jul 2024.
- Individual participant dataSharing planned: No. Purpose and Scope: This IPD plan outlines how individual participant data from the study "The Effects of Meditation on Stress and Fatigue in Intensive Care Nurses" will be shared and utilized. The data will be made available for verification of the study's findings and for further analysis by relevant researchers and scientific communities. Data Protection and Privacy: Participant data will be stored in compliance with national and international regulations to protect confidentiality. Data will only be shared for research purposes, ensuring participant identities are protected. Data Sharing Procedures: Data will be provided upon request to researchers and relevant institutions seeking to verify study results. Use of the data will be subject to approval by relevant ethics committees and for purposes of data sharing. Analysis Procedures: Data will be analyzed according to pre-established protocols, and findings will be presented in scientific reports. The methodology of analysis and i
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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 meditation in people with Intensive Care Nurses, run by Osmaniye Korkut Ata 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 5 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 24 Jul 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?
STRESS LEVELS (time frame: after 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?
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 24 Jul 2024.