Mindful Hand Hygiene for Healthcare Workers

NCT05261282 | Completed Results

• 1 other identifier: IIR 19-097
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test an intervention focused towards promoting mindfulness among VA physicians and nurses. Mindfulness is a tool that can help people focus. It helps clear the mind of distractions and biases. Some physicians and nurses will be randomized to receive the study intervention, while others will not. The study intervention will include the following: 1) education about mindfulness; 2) group discussions about mindfulness; and 3) an optional mobile app to promote mindfulness. Participants randomized to the intervention will be encouraged to use the act of cleansing their hands as a prompt for practicing mindfulness. The study will test if this intervention will increase physician and nurse mindfulness. It will also test if it leads to improved well-being and use of proper hand hygiene.

Conditions

Burnout; Mental Health

Keywords

Mindfulness; Hand Hygiene; Health Personnel

Outcome Measures

Primary Outcomes (6)

• The Five Facet Mindfulness Questionnaire (FFMQ) - Post-Intervention

  The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.

  Month 1

• Well-Being Index - Post-Intervention

  The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well being.

  Month 1

• Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Post-Intervention

  The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.

  Month 1

• The Five Facet Mindfulness Questionnaire (FFMQ) - Sustainability

  The Five Facet Mindfulness Questionnaire (FFMQ) is a validated instrument with favorable psychometric properties and consists of 39 questions. The scale could be broken into the subscales of Observing, Describing, Acting with Awareness, Nonjudging, Nonreactivity, or presented as a total score. The total FFMQ score is presented here on a scale from 1-5. Lower scores (1) mean less mindful, while higher scores (5) indicate the respondent is more mindful.

  Month 7

• Well-Being Index - Sustainability

  The 9-question Well-Being Index (WBI) assesses distress across a variety of dimensions including fatigue, depression, burnout, stress, and quality of life, and has been validated for use in physicians, residents, and nurses. Scores range from -2 (low-risk) to 9 (high risk). Lower scores indicate better well-being.

  Month 7

• Percentage of Situations Performing Hand Hygiene When Required (Self-Perception) - Sustainability

  The question assessing how often respondents felt they performed hand hygiene when required from the Perceptions Survey for Healthcare Workers (PSHW) developed by the World Health Organization was used. This question is scored on a scale of 0-100%. Higher scores indicate higher perception of performing hand hygiene when required.

  Month 7

Secondary Outcomes (9)

• Hand Hygiene Room Entry - Habituation

  Month 0

• Hand Hygiene Room Exit - Habituation

  Month 0

• Duration Hand Hygiene Room Exit - Habituation

  Month 0

• Hand Hygiene Room Entry - Intervention Period

  Month 1

• Hand Hygiene Room Exit - Intervention Period

  Month 1

Study Arms (2)

Mindful Hand Hygiene Intervention

EXPERIMENTAL

Participants in the Mindful Hand Hygiene Intervention will complete the same surveys as participants in the Control Arm at baseline, post-intervention, and 6-months post-intervention. Data will also be collected on baseline hand-hygiene rates during the habituation period, intervention period, and 3-12 months post-intervention. In addition, intervention participants will be asked to complete 3 mindfulness online educational modules and attend group-facilitated discussions on mindfulness. They will be offered the option of using a mobile application program "Mindfulness Coach" to enhance their mindfulness practices. A key message of the intervention is using hand hygiene as a prompt to practice mindfulness.

Behavioral: Mindful Hand Hygiene

Control Arm

NO INTERVENTION

Participants that are assigned to the control arm will be observed for hand hygiene adherence and duration during the habituation period, intervention period, and 3-12 months post-intervention. They will also be asked to complete study surveys at baseline, post-intervention and 6-months post intervention. They will not receive any of the intervention components.

Interventions

Mindful Hand Hygiene BEHAVIORAL

Physicians and nurses randomized to the intervention arm will receive mindfulness education and tools to prompt mindfulness during hand hygiene.

Mindful Hand Hygiene Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nurses on participating unit
• Physician on an inpatient medical team, including attending, senior resident, and intern physicians

You may not qualify if:

• Medical students
• Surgical attendings
• Physicians on sub-specialty teams

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (2)

• Kirykowicz K, Jaworski B, Owen J, Kirschbaum C, Seedat S, van den Heuvel LL. Feasibility, acceptability and preliminary efficacy of a mental health self-management app in clinicians working during the COVID-19 pandemic: A pilot randomised controlled trial. Psychiatry Res. 2023 Nov;329:115493. doi: 10.1016/j.psychres.2023.115493. Epub 2023 Sep 24.

  PMID: 37778231 RESULT

• Kulkarni PA, Greene MT, Saint S, Fowler KE, Jacob S, Dillon L, Espiritu M, Houchens N, Cozart HT, Trautner BW. Comparing observed with self-reported hand hygiene adherence among bedside nurses and physicians at two hospitals in the United States. Am J Infect Control. 2026 Mar;54(3):241-246. doi: 10.1016/j.ajic.2025.10.032. Epub 2025 Nov 7.

  PMID: 41207631 RESULT

MeSH Terms

Conditions

Burnout, Psychological; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Results Point of Contact

• Title: M. Todd Greene, PhD, MPH
• Organization: VA Center for Clinical Management Research

mtgreene@med.umich.edu

734-936-4795

Study Officials

• Michael Todd Greene, PhD MPH BS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

• Sanjay K. Saint, MD MPH

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff who conduct the hand hygiene observations for the physician teams will not know the randomization status of the physician teams. The investigators are unable to mask the research assistants from the randomization status of the nursing units.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a multi-center, repeat-measures, randomized controlled mixed-methods trial. At each study site the participating physician teams and nursing units will be randomly assigned into one of two study arms (intervention/control). For physician teams, this will occur on a rolling basis for 12 months with 2 physician teams randomly selected at each site each month for participation (1 intervention, 1 control). For nurses, 2-4 hospital units at each study site will be assigned to either intervention or control for the study period.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 2, 2022
• Study Start: November 7, 2022
• Primary Completion: December 8, 2024
• Study Completion: December 8, 2024
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the final publication from this study.
• Access Criteria: De-identified data will be provided after requesters sign a Letter of Agreement (LOA) detailing the mechanisms by which the data will be kept secure. The LOA will also state that the recipient will not attempt to identify any individual in the data, will not share the data outside of their research team, and will provide information on any files to be linked to the data. The dataset will not include PII and all dates will be changed to integers to allow for calculation of time periods.

Locations

US (2)