Stress (Psychology)NCT04942509
Mindful Coloring to Reduce Nurses' Stress
A study testing Coloring as a brief mindfulness-based intervention in people with Stress (Psychology) and Burn Out (Psychology), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress (Psychology), Burn Out (Psychology)
- What is being tested?
- Coloring as a brief mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Dec 2020to 12 Jan 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress (Psychology), Burn Out (Psychology)
- Being tested
- Coloring as a brief mindfulness-based intervention
- Keywords
- nurses, coloring, brief mindfulness-based intervention, mental well-being, mindfulness
- Medical subject headings
- Burnout, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloring as a brief mindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coloring | Experimental | This group did mindful coloring for at least 5 days or at least 100 minutes in total during a 10-day period Receives: Behavioral: Coloring as a brief mindfulness-based intervention |
| Wait-list control | No intervention | This group did not do mindful coloring at all during a 10-day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
Secondary outcomes (3)
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.
Measured: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
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.
Measured: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
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.
Measured: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start7 Dec 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress (Psychology)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated into the experimental and wait-list control groups. The experimental group colored for at least 5 days during a 10-day period while the control group did not.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- City University of Hong Kong
- Responsible party
- Principal investigator, Janet Fong, Chinese University of Hong Kong
- Investigators
- Shuk Yan Janet Fong, MSocSc, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942509
- Sponsor's protocol ID
- SBRE-20-162
- Status last verified
- Jun 2021
- First submitted
- 6 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants were ensured confidentiality in this study.
Publications
Fong JSY, Hui ANN, Ho KM, Chan AKM, Lee A. Brief mindful coloring for stress reduction in nurses working in a Hong Kong hospital during COVID-19 pandemic: A randomized controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31253. doi: 10.1097/MD.0000000000031253.
PubMed 36316873
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coloring as a Brief Mindfulness-based Intervention for Stress Reduction Among Nurses
- ClinicalTrials.gov ID
- NCT04942509
- Acronym / sponsor ID
- SBRE-20-162
- Conditions
- Stress (Psychology), Burn Out (Psychology)
- Keywords
- nurses, coloring, brief mindfulness-based intervention, mental well-being, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- City University of Hong Kong
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 28 Jun 2021 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated into the experimental and wait-list control groups. The experimental group colored for at least 5 days during a 10-day period while the control group did not.
| Arm | Type | Receives |
|---|---|---|
| Coloring | Experimental | Behavioral: Coloring as a brief mindfulness-based interventionThis group did mindful coloring for at least 5 days or at least 100 minutes in total during a 10-day period |
| Wait-list control | No intervention | –This group did not do mindful coloring at all during a 10-day period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Coloring as a brief mindfulness-based interventionParticipants 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. | Behavioural | Coloring |
Primary outcome
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.
3 secondary outcomes
Change in mental well-being
Time frame: 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)
Change in trait mindfulness
Time frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)
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 30 Jun 2021.
- Derived from this study: PubMed 36316873Fong JSY, Hui ANN, Ho KM, Chan AKM, Lee A. Brief mindful coloring for stress reduction in nurses working in a Hong Kong hospital during COVID-19 pandemic: A randomized controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31253. doi: 10.1097/MD.0000000000031253.
- Individual participant dataSharing planned: No. Participants were ensured confidentiality in this study.
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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.
Shuk Yan Janet Fong, MSocSc principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coloring as a brief mindfulness-based intervention in people with Stress (Psychology) and Burn Out (Psychology), run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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 30 Jun 2021. 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 Hong Kong. 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?
Change in perceived stress (time frame: Time point 1: pre-intervention. Time point 2: post-intervention (10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942509, which also lists 1 linked publication.
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 30 Jun 2021.