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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04942509
Other study ID # SBRE-20-162
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2020
Est. completion date January 12, 2021

Study information

Verified date June 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date January 12, 2021
Est. primary completion date January 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Behavioral:
Coloring as a brief mindfulness-based intervention
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.

Locations

Country Name City State
Hong Kong Prince of Wales Hospital Hong Kong Shatin

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong City University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perceived stress 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 Change in mental well-being 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)
Secondary Change in burnout 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)
Secondary Change in trait mindfulness 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)
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