Mindfulness is a Moment by Moment Awareness to Remain Purposefully and Non Judgmentally Attentive to Their Own ExperienceNCT04572464
Effectiveness of Mindfulness Based Meditation on Well-being, Self Compassion & Cognizance Among Nurses Working in Intensive Care Units
A study testing Mindfulness Based Guided Meditation in people with Mindfulness is a Moment by Moment Awareness to Remain Purposefully and Non Judgmentally Attentive to Their Own Experience, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Effect of Mindfulness Based Guided Meditation on Intensive care Unit nurses wellbeing,cognizance \& self compassion was assessed . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mindfulness is a Moment by Moment Awareness to Remain Purposefully and Non Judgmentally Attentive to Their Own Experience
- What is being tested?
- Mindfulness Based Guided Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteIndia
- Study dates
- 14 Jun 2019to 30 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered nurses who were Working in ICUs for at least last three months continuously.
Who cannot join
- Registered nurses who were On long leave Had joined recently in ICUs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pre-Experimental Study to Assess the Effectiveness of Mindfulness Based Guided Meditation on Wellbeing, Self Compassion and Cognizance Among Nurses Working in Intensive Care Units at ILBS, New Delhi
Effect of Mindfulness Based Guided Meditation on Intensive care Unit nurses wellbeing,cognizance \& self compassion was assessed .
Read the detailed description
: Primary objective To assess the Effectiveness of Mindfulness Based Guided Meditation on Wellbeing, Self Compassion and Cognizance among Nurses working in Intensive Care Units at ILBS.
Hypothesis
The following hypothesis will be tested at 0.05 level of significance:
H1There will be a significant difference between pretest Wellbeing scores and posttest Wellbeing scores of Nurses working in Intensive Care Units. H2There will be a significant difference between pretest Self Compassion Scores and posttest Self Compassion scores of Nurses working in Intensive Care Unit.
H3There will be a significant difference between pretest Cognizance Scores and posttest Cognizance score of Nurses Working in Intensive Care Units.
H4 There will be a significant relationship between Wellbeing and Self Compassion Among Nurses working in Intensive Care Units.
H5 There will be a significant relationship between Wellbeing and Cognizance among Nurses working in Intensive Care Units.
H6 There will be a significant relationship between Self Compassion and Cognizance Among Nurses working in Intensive Care Units.
H7 There will be a significant association of posttest wellbeing score with selected Socio demographic variables of Nurses working in Intensive Care Units.
H8 There will be a significant association of posttest Self Compassion score with selected sociodemographic variables of Nurses working in Intensive Care Units.
H9 There will be a significant association of Posttest Cognizance score with selected sociodemographic variables of Nurses working in Intensive Care Units.
Research Design Pre-experimental, one group pre test -post test design
- Being tested
- Mindfulness Based Guided Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Guided MeditationOther
Mindfulness Based Guided Meditation will be practiced by nurses under the supervision of researcher for 15 min thrice a week for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Mindfulness Based Guided Meditation Receives: Other: Mindfulness Based Guided Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing
The study will be carried out among Nurses working in Intensive Care Units at ILBS Hospital using Total enumeration technique. The primary outcome measure will be increase in post test wellbeing scores among nurses as compared to their pretest wellbeing scores which will be assessed by using Warwick Edinburgh Mental Wellbeing scale in about 10 mins.
Measured: 10 minutes
Self Compassion
The study will be carried out among Nurses working in Intensive Care Units at ILBS hospital using Total enumeration technique.The primary outcome measure will be increase in post test Self Compassion scores among nurses as compared to their pre test Self Compassion scores which will be measured using Self Compassion Scale in about 15 mins.
Measured: 15 minutes
Self Compassion
The study will be carried out among Nurses working in Intensive Care Units at ILBS hospital using Total enumeration technique. The primary outcome measure will be increase in post test Cognizance score among nurses as compared to their pretest Cognizance scores which will be measured using Mindful Attention Awareness Scale in about 10 mins
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start14 Jun 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness is a Moment by Moment Awareness to Remain Purposefully and Non Judgmentally Attentive to Their Own ExperienceStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- One group pre test post test
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572464
- Sponsor's protocol ID
- F15(2/2.25)/2017/HO(M)/ILBS
- Status last verified
- Nov 2019
- First submitted
- 22 Jul 2020
- Last updated
- 1 Oct 2020
- 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 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Experimental Study to Assess the Effectiveness of Mindfulness Based Guided Meditation on Wellbeing, Self Compassion and Cognizance Among Nurses Working in Intensive Care Units at ILBS, New Delhi
- ClinicalTrials.gov ID
- NCT04572464
- Acronym / sponsor ID
- F15(2/2.25)/2017/HO(M)/ILBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Oct 2020 (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.
Effect of Mindfulness Based Guided Meditation on Intensive care Unit nurses wellbeing,cognizance \& self compassion was assessed .
Detailed description
: Primary objective To assess the Effectiveness of Mindfulness Based Guided Meditation on Wellbeing, Self Compassion and Cognizance among Nurses working in Intensive Care Units at ILBS.
Hypothesis
The following hypothesis will be tested at 0.05 level of significance:
H1There will be a significant difference between pretest Wellbeing scores and posttest Wellbeing scores of Nurses working in Intensive Care Units. H2There will be a significant difference between pretest Self Compassion Scores and posttest Self Compassion scores of Nurses working in Intensive Care Unit.
H3There will be a significant difference between pretest Cognizance Scores and posttest Cognizance score of Nurses Working in Intensive Care Units.
H4 There will be a significant relationship between Wellbeing and Self Compassion Among Nurses working in Intensive Care Units.
H5 There will be a significant relationship between Wellbeing and Cognizance among Nurses working in Intensive Care Units.
H6 There will be a significant relationship between Self Compassion and Cognizance Among Nurses working in Intensive Care Units.
H7 There will be a significant association of posttest wellbeing score with selected Socio demographic variables of Nurses working in Intensive Care Units.
H8 There will be a significant association of posttest Self Compassion score with selected sociodemographic variables of Nurses working in Intensive Care Units.
H9 There will be a significant association of Posttest Cognizance score with selected sociodemographic variables of Nurses working in Intensive Care Units.
Research Design Pre-experimental, one group pre test -post test design
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pre test post test
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Mindfulness Based Guided MeditationMindfulness Based Guided Meditation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Registered nurses who were Working in ICUs for at least last three months continuously.
Key exclusion criteria (1 listed)
- Registered nurses who were On long leave Had joined recently in ICUs
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 Guided MeditationMindfulness Based Guided Meditation will be practiced by nurses under the supervision of researcher for 15 min thrice a week for two weeks | Other | Experimental |
Primary outcome
Wellbeing
Time frame: 10 minutes
The study will be carried out among Nurses working in Intensive Care Units at ILBS Hospital using Total enumeration technique. The primary outcome measure will be increase in post test wellbeing scores among nurses as compared to their pretest wellbeing scores which will be assessed by using Warwick Edinburgh Mental Wellbeing scale in about 10 mins.
Self Compassion
Time frame: 15 minutes
The study will be carried out among Nurses working in Intensive Care Units at ILBS hospital using Total enumeration technique.The primary outcome measure will be increase in post test Self Compassion scores among nurses as compared to their pre test Self Compassion scores which will be measured using Self Compassion Scale in about 15 mins.
Self Compassion
Time frame: 10 minutes
The study will be carried out among Nurses working in Intensive Care Units at ILBS hospital using Total enumeration technique. The primary outcome measure will be increase in post test Cognizance score among nurses as compared to their pretest Cognizance scores which will be measured using Mindful Attention Awareness Scale in about 10 mins
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 1 Oct 2020.
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 Guided Meditation in people with Mindfulness is a Moment by Moment Awareness to Remain Purposefully and Non Judgmentally Attentive to Their Own Experience, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 Oct 2020. 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 India. 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?
Wellbeing (time frame: 10 minutes). The study lists 3 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 1 Oct 2020.