- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04942509
Mindful Coloring to Reduce Nurses' Stress
June 25, 2021 updated by: Janet Fong, Chinese University of Hong Kong
Coloring as a Brief Mindfulness-based Intervention for Stress Reduction Among Nurses
The purpose of this study was to investigate whether nurses who did mindful coloring for at least five working days during a 10-day period experienced stress reduction afterwards.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Enrolled participants who met inclusion criteria (full-time clinical nurses working for at least five days during a specified 10-day period) were randomized in 1:1 ratio to the coloring or control groups.
A third party did the allocation sequence and concealment.
After giving informed consent, participants completed the baseline questionnaire and the coloring group watched an instructional video on mindful coloring.
The coloring group were asked to color for any length of time on at least five working days during a 10-day period (period A) while the control group were asked to do it on a subsequent 10-day (period B).
The post-intervention questionnaire was completed by both groups at the end of period A. The study was completed after period B.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shatin
-
Hong Kong, Shatin, Hong Kong, 852
- Prince of Wales Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Full time clinical nurses working under the Hospital Authority who would be working for at least 5 days during a specified 10-day study period.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coloring
This group did mindful coloring for at least 5 days or at least 100 minutes in total during a 10-day period
|
Participants watched an instructional video on mindful coloring at the beginning of the intervention and colored mindfully for at least 5 days or 100 minutes in total during a 10-day period.
The intervention included a coloring booklet that contained mandala patterns for coloring.
|
|
No Intervention: Wait-list control
This group did not do mindful coloring at all during a 10-day period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in perceived stress
Time Frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Scores of 0-40 measured by the Perceived Stress Scale.
A positive outcome is indicated by a lower post-intervention score.
|
Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mental well-being
Time Frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Scores of 7-35 measured by the short Warwick-Edinburgh Mental Well-being Scale.
A positive outcome is indicated by a higher post-intervention score.
|
Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
|
Change in burnout
Time Frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Three subscales (each with a separate score) assessing three facets of burnout including Emotional Exhaustion (scores 0-54), Depersonalisation (scores 0-30) and Personal Accomplishment (scores 0-48) measured by the Maslach Burnout Inventory - Human Services Survey for medical personnel.
Burnout is represented by a combination of high emotional exhaustion and depersonalization scores, together with a low personal accomplishment score.
Positive outcomes are indicated by a lower score in Emotional Exhaustion and Depersonalisation, and a higher score in Personal Accomplishment.
|
Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
|
Change in trait mindfulness
Time Frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Scores of 24-120 measured by the Five Facets Mindfulness Questionnaire - short form.
A positive outcome is indicated by a higher post-intervention score.
|
Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shuk Yan Janet Fong, MSocSc, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2020
Primary Completion (Actual)
January 12, 2021
Study Completion (Actual)
January 12, 2021
Study Registration Dates
First Submitted
June 6, 2021
First Submitted That Met QC Criteria
June 23, 2021
First Posted (Actual)
June 28, 2021
Study Record Updates
Last Update Posted (Actual)
June 30, 2021
Last Update Submitted That Met QC Criteria
June 25, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBRE-20-162
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Participants were ensured confidentiality in this study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.