MindfulnessNCT04557033
My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
A study testing Mindfulness intervention in people with Mindfulness and Meditation, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Meditation
- What is being tested?
- Mindfulness intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 30 Jul 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
- Adults ≥18 years of age
- Currently employed at Dana Farber Cancer Institute
- Providing patient care on Yawkey
Who cannot join
- Not an employee of Dana Farber Cancer Institute
- Not providing Patient Care on Yawkey
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute .
Read the detailed description
This project provides an opportunity for patient care staff in an ambulatory oncology setting to participate in and evaluate an activity that includes a mindfulness meditation technique and an expressive digital arts activity.
This study will be conducted to evaluate the feasibility of providing a mindfulness meditation and digital imagery activity.
- The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.
- Participants will be asked to complete brief surveys before and after the intervention activity.
- Conditions
- Mindfulness, Meditation
- Being tested
- Mindfulness intervention
- Keywords
- Mindfulness, Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionOther
My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media
| Study group | Role | What they receive |
|---|---|---|
| Mindful Meditation | Experimental | * The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.
* The My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media
* Participants will be asked to complete brief surveys before and after the intervention activity. Receives: Other: Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participation-Feasibility
≥50% of staff choose to participate=Feasibility. This measure of feasibility will be evaluated by calculating index scores of the percentage of clinical staff who choose to participate
Measured: 1 year
Percentage Completion of Full Activity-Feasibility
> 80% of those who participate complete the activity=Feasibility. This measure of feasibility will be evaluated by index scores of the percentage of clinical staff who complete the full activity
Measured: 1 year
Mean Completion Time-Feasibility
The activity is completed by the group in 40 minutes or less-Feasibility. This measure of feasibility will be evaluatedby individual group completions times and overall analysis of descriptive statistics on the time for completion of the activity by all groups.
Measured: 1 year
Secondary outcomes (1)
Change in Anxiety Score
Changes in participant state anxiety will be evaluated using the visual analogue scale in measuring state anxiety. The electronic scale displays a horizontal line divided into 30 equal-sized partitions. The left edge of the scale is marked "calm" and the right edge is marked "anxious." A sliding locator is positioned at the midpoint of the scale. The participant is instructed to use the computer mouse to place the locator at the scale position representing their current level of anxiety. The score is automatically calculated by rounding the relative distance of the locator from the left edge of the scale to the nearest integer value between 0 and 30. A higher score indicates greater anxiety. A comparison of scores pre- and post- intervention by calculating a paired t-test comparison of means
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Jabaley, Dana-Farber Cancer Institute
- Investigators
- Terri Jabaley, Ph.D, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557033
- Sponsor's protocol ID
- 20-420
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
- ClinicalTrials.gov ID
- NCT04557033
- Acronym / sponsor ID
- 20-420
- Conditions
- Mindfulness, Meditation
- Keywords
- Mindfulness, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 21 Sep 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.
The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute .
Detailed description
This project provides an opportunity for patient care staff in an ambulatory oncology setting to participate in and evaluate an activity that includes a mindfulness meditation technique and an expressive digital arts activity.
This study will be conducted to evaluate the feasibility of providing a mindfulness meditation and digital imagery activity.
- The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.
- Participants will be asked to complete brief surveys before and after the intervention activity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful Meditation | Experimental | Other: Mindfulness intervention* The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad. * The My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media * Participants will be asked to complete brief surveys before and after the intervention activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years of age
- Currently employed at Dana Farber Cancer Institute
- Providing patient care on Yawkey
Key exclusion criteria (2 listed)
- Not an employee of Dana Farber Cancer Institute
- Not providing Patient Care on Yawkey
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 interventionMy Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media | Other | Mindful Meditation |
Primary outcome
Percentage of Participation-Feasibility
Time frame: 1 year
≥50% of staff choose to participate=Feasibility. This measure of feasibility will be evaluated by calculating index scores of the percentage of clinical staff who choose to participate
Percentage Completion of Full Activity-Feasibility
Time frame: 1 year
> 80% of those who participate complete the activity=Feasibility. This measure of feasibility will be evaluated by index scores of the percentage of clinical staff who complete the full activity
Mean Completion Time-Feasibility
Time frame: 1 year
The activity is completed by the group in 40 minutes or less-Feasibility. This measure of feasibility will be evaluatedby individual group completions times and overall analysis of descriptive statistics on the time for completion of the activity by all groups.
1 secondary outcome
Change in Anxiety Score
Time frame: 1 Year
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 25 Aug 2022.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Terri Jabaley, Ph.D, RN principal investigator
Dana-Farber Cancer Institute
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 intervention in people with Mindfulness and Meditation, run by Dana-Farber Cancer Institute at 1 site in United States.
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 3 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 25 Aug 2022. 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 United States. 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?
Percentage of Participation-Feasibility (time frame: 1 year). 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 25 Aug 2022.