NCT04282733

Brief Summary

An 8 week course of mindfulness education and practices will be presented to all staff, patients, and visitors voluntarily attending the thrice weekly presentations. The goal is to reduce staff stress, improve communication, enhance patient satisfaction, and improve quality of care.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

February 21, 2020

Last Update Submit

January 30, 2024

Conditions

Keywords

MindfulnessStresspain scorespatient satisfactionPerceived Stress ScaleMBSR

Outcome Measures

Primary Outcomes (1)

  • Change in Pain scores

    Patient pain scores are routinely collected by Nursing and entered into the electronic medical record (EMR). Full pain scale from 0-10, higher score indicates more pain.

    1-3 months pre-intervention, 1-3 months post-intervention

Secondary Outcomes (9)

  • Discharge time

    1-3 months pre-intervention, 1-3 months post-intervention

  • Change in Narcotic usage

    1-3 months pre-intervention, 1-3 months post-intervention

  • Change in Patient Satisfaction survey

    1-3 months pre-intervention, 1-3 months post-intervention

  • Change in Perceived Stress Scale (PSS) survey

    Within 1 month prior to intervention, within one month post the intervention.

  • Change in number of Staff sick days

    1-3 months pre-intervention, 1-3 months post-intervention

  • +4 more secondary outcomes

Study Arms (2)

Mindfulness Rounds

EXPERIMENTAL

Participants will be exposed to thrice weekly Mindfulness Rounds education on the Unit; participation in the actual sessions is voluntary.

Behavioral: Mindfulness Rounds

Control

NO INTERVENTION

No intervention will take place on this Unit

Interventions

Throughout the 8-week study period, a different mindfulness practice will be introduced weekly in 3 separate 15-minute live sessions. Posters describing the particular "practice of the week" will be placed around the Unit as visual reminders to encourage actual practice.

Mindfulness Rounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Employees on the Units

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jeffrey Zahn, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The participants are staff on two hospital units tending to the same patient population with the same policies and protocols - postpartum patients. One unit will have the Mindfulness Rounds Initiative as the intervention, the other will not. Both units will be evaluated against each other, and against themselves in a pre-/post- design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

March 18, 2021

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations