Face-touching BehaviorNCT04330352
Mindfulness-based "STOP (Stop, Take a Breath, Observe, Proceed) Touching Your Face" Intervention
A study testing Mindfulness-based "STOP touching your face" practice in people with Face-touching Behavior, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "STOP touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Face-touching Behavior
- What is being tested?
- Mindfulness-based "STOP touching your face" practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,094 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 2 Jul 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Being able to access online services
- Being able to read and write in Chinese
- Expressing an interest in participant this study
- Willing to provide informed consent to participate in the study
Who cannot join
- Under 18 years of age
- Unable to access online services
- Unable to read and write in Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "STOP Touching Your Face": a Randomized Controlled Trial of Brief Mindfulness-based Intervention
This single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "STOP touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like COVID-19.
Read the detailed description
Background Face-touching behavior often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behavior disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named "STOP (Stop, Take a Breath, Observe, Proceed) touching your face" in reducing face-touching behavior.
Methods This will be a single-blind, randomized, controlled, trial. We will recruit 1,000 participants, and will randomize and allocate participants 1:1 to the "STOP touching your face" intervention group (n=500) and the control group (n=500). All participants will be asked to monitor and record their face-touching behavior. The intervention group will receive the brief online mindfulness-based "STOP touching your face" program, and the control group will receive control intervention. Primary outcome will be the efficacy of short-term mindfulness-based "STOP touching your face" intervention for reducing the frequency of face-touching. The secondary outcomes will be the reduction of the duration of face-touching after intervention; the correlation between the psychological traits of mindfulness and face-touching behavior; and the differences of face-touching behavior between left-handers and right-handers. We will recruit 1000 participants from April to June 2020 or until the recruitment process is complete. The follow-up will be completed in June 2020. We expect all trial results to be available by the end of June 2020.
Discussion This is the first RCT to evaluate the efficacy of brief mindfulness intervention to reduce face-touching behavior. We expect that "STOP touching your face" has a significantly greater reduction the frequency of face-touching behavior than the control intervention. As "STOP touching your face" is a brief and simple skill, the public health impact of its expansion world-wide could be enormous, helping us to manage any face-touching spread infectious diseases, like Coronavirus disease 2019 (COVID-19).
- Conditions
- Face-touching Behavior
- Being tested
- Mindfulness-based "STOP touching your face" practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based "STOP touching your face" practiceBehavioural
- Remind yourself to STOP. Whatever you are doing in this moment (e.g. touching your month, pinching your nose, rubbing your eyes, resting your chin on your hands), pause for a minute. 2. Take a deep breath. This reconnects you with your body. Pay attention to your breathing and just allow yourself to continue to breathe normally and naturally. 3. Observe what is happening for you in this moment-including thoughts, feelings, and emotions (e.g. feel distracted, anxious or nervous?). What do you notice in your body (e.g. feel itchy or tingling on any part of your face)? You can be aware of anything: posture, sensations, tension in your body, or, once again, your breath. You might notice the sound around you. You might even notice your thoughts or emotions. 4. Proceed with whatever you were doing before you came to a STOP or something that you want to do in the moment (e.g. proceed with touching your face, or stop face-touching and take an alternative behavior).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based "STOP touching your face" intervention | Experimental | Eligibility participants who are allocated to the intervention group will be required to find a time to monitor and record their behavior of hand-to-face contacts, including the frequency and length (in second) of face-touching in any of the mucosal area (eyes, nose, mouth) and nonmucosal area (ears, cheeks, chin, neck, forehead, hair) during a 60-minute period. Then, they will receive the online mindfulness-based "STOP touching your face" program. Each participant will be required to practice this technique until they feel confident and natural. The systematic review showed the efficacy of single session of brief MBIs, the average length was 15 minutes, ranged from less than 5 to 25 min. Thus, the requirement practice time will be at least 15 minutes (excluding the time of reading the text and the first time of listening to the audio). Later (at least 1-hour interval), they will be asked to self-monitor and report their one-hour face-touching behavior again. Receives: Behavioral: Mindfulness-based "STOP touching your face" practice |
| Contron information intervention | No intervention | Participants who allocate to the control group will only receive information to thank them and encourage them to complete the study. They will receive "STOP touching your face" program after the end of this study. The repeat measurement of the face-touching behavior will be in at least 1-hour interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of frequency of face-touching behavior
This will be calculated as the total times of face-touching (including the eyes, nose, mouth, ears, cheeks, chin, neck, forehead, hair) during a 60-minute period before the intervention minus the total times of face-touching after the intervention.
Measured: 2 hours
Secondary outcomes (3)
Reduction of percentage of participants touching their faces
This will be calculated as the percentage of participants touching their faces (including any of the following areas: the eyes, nose, mouth, ears, cheeks, chin, neck, forehead, hair) during a 60-minute period before the intervention minus the percentage of participants touching their faces after the intervention.
Measured: 2 hours
Five Facet Mindfulness Questionnaire (FFMQ)
To measure the correlation between the psychological traits of mindfulness (measured by FFMQ) and face-touching behavior. The self-report scale of FFMQ is currently the most frequently used mindfulness questionnaire to measure changes in participant's tendency to be mindful in daily life by the following five related facets: observing(noticing, attending to sensations, perceptions, thoughts, feelings; 8 items), describing (labeling feelings, thoughts with words), acting with awareness (automatic pilot, concentration, non-distraction), non-judging internal experience, and non-reactivity to internal experience. Participants will be asked to what extent each of the statements are true of them. Each item is on a 1 to 5 Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The factor structure of the short version (FFMQ-15) will be used in this study, which has been consistent with that of the FFMQ-39.
Measured: 2 hours
The Edinburgh Handedness Inventory (EHI)
To measure the differences of face-touching behavior between left-handers and right-handers. EHI is the most widely used 10-item self-report inventory to assess handedness. It is comprised of the following 10 activities: (1) writing, (2) drawing, (3) throwing, (4) using scissors, (5) a toothbrush (6) knife (without fork), (7) spoon, and such activities involving both hands as (8) using a broom (upper hand), (9) striking a match, and (10) unscrewing the lid of a bottle. To complete the EHI, one or two check marks are placed under "left (L)" or "right (R)" columns, indicating strength of preference for each activity. Participants will be asked write "2", "1" or "0" in the appropriate corresponding column. If the preference is very strong that they would never try to use the other hand unless absolutely forced to, then they will mark this column as "2" and the other column as "0". If they are really indifferent, they will mark it as "1" in both columns.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start2 Apr 2020
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Face-touching BehaviorStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhui Liao, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330352
- Sponsor's protocol ID
- 2020S001
- Status last verified
- Sep 2020
- First submitted
- 27 Mar 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tang J, Wang L, Luo T, Wu S, Wu Z, Chen J, Pan C, Wang Y, Liu Y, Luo Q, Guo X, Xie L, Zhou J, Sun Y, Chen W, Liao Y. Effectiveness of a Brief Mindfulness-Based Intervention of "STOP touching your face" During the COVID-19 Pandemic: a Randomized Controlled Trial. Mindfulness (N Y). 2022;13(12):3123-3133. doi: 10.1007/s12671-022-02019-x. Epub 2022 Nov 9.
PubMed 36408118Liao Y, Wang L, Luo T, Wu S, Wu Z, Chen J, Pan C, Wang Y, Liu Y, Luo Q, Guo X, Xie L, Zhou J, Chen W, Tang J. Brief mindfulness-based intervention of 'STOP (Stop, Take a Breath, Observe, Proceed) touching your face': a study protocol of a randomised controlled trial. BMJ Open. 2020 Nov 24;10(11):e041364. doi: 10.1136/bmjopen-2020-041364.
PubMed 33234653
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "STOP Touching Your Face": a Randomized Controlled Trial of Brief Mindfulness-based Intervention
- ClinicalTrials.gov ID
- NCT04330352
- Acronym / sponsor ID
- 2020S001
- Conditions
- Face-touching Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,094 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 2 Apr 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 1 Apr 2020 (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.
This single-blind, randomized, controlled, trial is to assess the efficasy of a brief mindfulness-based "STOP touching your face" training program to reduce or avoid face-touching to low people's chances of catching infectious diseases like COVID-19.
Detailed description
Background Face-touching behavior often happens frequently and automatically, and poses potential risk for spreading infectious disease. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of behavior disorders. This study aims to evaluate an online mindfulness-based brief intervention skill named "STOP (Stop, Take a Breath, Observe, Proceed) touching your face" in reducing face-touching behavior.
Methods This will be a single-blind, randomized, controlled, trial. We will recruit 1,000 participants, and will randomize and allocate participants 1:1 to the "STOP touching your face" intervention group (n=500) and the control group (n=500). All participants will be asked to monitor and record their face-touching behavior. The intervention group will receive the brief online mindfulness-based "STOP touching your face" program, and the control group will receive control intervention. Primary outcome will be the efficacy of short-term mindfulness-based "STOP touching your face" intervention for reducing the frequency of face-touching. The secondary outcomes will be the reduction of the duration of face-touching after intervention; the correlation between the psychological traits of mindfulness and face-touching behavior; and the differences of face-touching behavior between left-handers and right-handers. We will recruit 1000 participants from April to June 2020 or until the recruitment process is complete. The follow-up will be completed in June 2020. We expect all trial results to be available by the end of June 2020.
Discussion This is the first RCT to evaluate the efficacy of brief mindfulness intervention to reduce face-touching behavior. We expect that "STOP touching your face" has a significantly greater reduction the frequency of face-touching behavior than the control intervention. As "STOP touching your face" is a brief and simple skill, the public health impact of its expansion world-wide could be enormous, helping us to manage any face-touching spread infectious diseases, like Coronavirus disease 2019 (COVID-19).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based "STOP touching your face" intervention | Experimental | Behavioral: Mindfulness-based "STOP touching your face" practiceEligibility participants who are allocated to the intervention group will be required to find a time to monitor and record their behavior of hand-to-face contacts, including the frequency and length (in second) of face-touching in any of the mucosal area (eyes, nose, mouth) and nonmucosal area (ears, cheeks, chin, neck, forehead, hair) during a 60-minute period. Then, they will receive the online mindfulness-based "STOP touching your face" program. Each participant will be required to practice this technique until they feel confident and natural. The systematic review showed the efficacy of single session of brief MBIs, the average length was 15 minutes, ranged from less than 5 to 25 min. Thus, the requirement practice time will be at least 15 minutes (excluding the time of reading the text and the first time of listening to the audio). Later (at least 1-hour interval), they will be asked to self-monitor and report their one-hour face-touching behavior again. |
| Contron information intervention | No intervention | –Participants who allocate to the control group will only receive information to thank them and encourage them to complete the study. They will receive "STOP touching your face" program after the end of this study. The repeat measurement of the face-touching behavior will be in at least 1-hour interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Being able to access online services
- Being able to read and write in Chinese
- Expressing an interest in participant this study
- Willing to provide informed consent to participate in the study
Key exclusion criteria (3 listed)
- Under 18 years of age
- Unable to access online services
- Unable to read and write in Chinese
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 |
|---|---|---|
| Mindfulness-based "STOP touching your face" practice1. Remind yourself to STOP. Whatever you are doing in this moment (e.g. touching your month, pinching your nose, rubbing your eyes, resting your chin on your hands), pause for a minute. 2. Take a deep breath. This reconnects you with your body. Pay attention to your breathing and just allow yourself to continue to breathe normally and naturally. 3. Observe what is happening for you in this moment-including thoughts, feelings, and emotions (e.g. feel distracted, anxious or nervous?). What do you notice in your body (e.g. feel itchy or tingling on any part of your face)? You can be aware of anything: posture, sensations, tension in your body, or, once again, your breath. You might notice the sound around you. You might even notice your thoughts or emotions. 4. Proceed with whatever you were doing before you came to a STOP or something that you want to do in the moment (e.g. proceed with touching your face, or stop face-touching and take an alternative behavior). | Behavioural | Mindfulness-based "STOP touching your face" intervention |
Primary outcome
Reduction of frequency of face-touching behavior
Time frame: 2 hours
This will be calculated as the total times of face-touching (including the eyes, nose, mouth, ears, cheeks, chin, neck, forehead, hair) during a 60-minute period before the intervention minus the total times of face-touching after the intervention.
3 secondary outcomes
Reduction of percentage of participants touching their faces
Time frame: 2 hours
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 2 hours
The Edinburgh Handedness Inventory (EHI)
Time frame: 2 hours
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 Sep 2020.
- Derived from this study: PubMed 36408118Tang J, Wang L, Luo T, Wu S, Wu Z, Chen J, Pan C, Wang Y, Liu Y, Luo Q, Guo X, Xie L, Zhou J, Sun Y, Chen W, Liao Y. Effectiveness of a Brief Mindfulness-Based Intervention of "STOP touching your face" During the COVID-19 Pandemic: a Randomized Controlled Trial. Mindfulness (N Y). 2022;13(12):3123-3133. doi: 10.1007/s12671-022-02019-x. Epub 2022 Nov 9.
- Derived from this study: PubMed 33234653Liao Y, Wang L, Luo T, Wu S, Wu Z, Chen J, Pan C, Wang Y, Liu Y, Luo Q, Guo X, Xie L, Zhou J, Chen W, Tang J. Brief mindfulness-based intervention of 'STOP (Stop, Take a Breath, Observe, Proceed) touching your face': a study protocol of a randomised controlled trial. BMJ Open. 2020 Nov 24;10(11):e041364. doi: 10.1136/bmjopen-2020-041364.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based "STOP touching your face" practice in people with Face-touching Behavior, run by Sir Run Run Shaw Hospital at 1 site in China.
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 5 inclusion and 3 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 Sep 2020. 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 China. 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?
Reduction of frequency of face-touching behavior (time frame: 2 hours). 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 NCT04330352, which also lists 2 linked publications.
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 Sep 2020.