Subjective StressNCT04844398
Clown Visits in Child and Adolescent Psychiatry
A study testing Clown visits by RED NOSES Clowndoctors Austria in people with Subjective Stress and Mood States, run by University of Vienna.
Trial summary
This pilot study aims at investigating short-term effects of clown visits by RED NOSES Clowndoctors Austria in children and adolescents in psychiatric care without control group. It is assumed that children and adolescents involved in an interaction with the clowns will experience a shift in their focus. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Subjective Stress, Mood States, Physiological Stress
- What is being tested?
- Clown visits by RED NOSES Clowndoctors Austria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jun 2022
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being aged between 7 and 18 years;
- Currently being in inpatient or outpatient psychiatric treatment;
- Regularly participating in clown visits at the relevant health facility;
- A written consent of the child's legal guardian.
Who cannot join
- Potential negative impacts of clown visits or study participation on participants' health or well-being according to medical or paramedical care staff of the relevant health facility;
- Insufficient command of German (for self-reports only).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Clown Visits by RED NOSES Clowndoctors Austria on Stress and Mood in Children and Adolescents in Psychiatric Care - A Pilot Study
This pilot study aims at investigating short-term effects of clown visits by RED NOSES Clowndoctors Austria in children and adolescents in psychiatric care without control group. It is assumed that children and adolescents involved in an interaction with the clowns will experience a shift in their focus. Individual attention and distraction from painful emotions have the ability to redirect their attention to the current pleasurable moment and increase their level of energy. Scientific evidence has shown that the distraction and switch to positive emotions associated with healthcare clowning can decrease the level of stress and pain (Vagnoli et al., 2005; Dionigi et al., 2014).
The study examines subjective and physiological stress levels of participants receiving clown visits in a group setting on a weekly basis. Using a non-controlled pre-/post-test design, the level of salivary cortisol and self-reported stress and mood will be measured before and after each clown visit over four consecutive weeks. Additionally, effects on care staff at the health facilities will be assessed based on a questionnaire after each clown visit within the same time period of four weeks. The sample will consist of approximately 40 children and adolescents in inpatient or outpatient psychiatric care. The examined intervention, i.e. clown visits by RED NOSES Clowndoctors Austria, is an integral part within the selected psychiatric health care institutions.
Read more
The study hypotheses are:
- Children and adolescents will report a reduced subjective stress level and better mood states in the three assessed dimensions (good - bad mood; alertness - tiredness; calmness - restlessness) after the experience of a clown visit (post-test) compared to before the clown visit (pre-test) independent of age and gender.
- Children and adolescents will display a reduced cortisol level after the experience of a clown visit (post-test) compared to before the clown visit (pre-test) independent of age and gender.
- The more frequently children and adolescents experience the weekly clown visits over the course of the four-week study, the stronger the stress-reducing and mood-enhancing effects in the pre-/post-comparison will be over time.
- Self-reported perceptions of care staff at the health facilities will indicate a positive effect of the clown visits on their own individual moods, the atmosphere within the care team, and the patients' well-being.
Read the detailed description
This pilot study will examine the effects of clown visits by RED NOSES Clowndoctors Austria on physiological and psychological stress indicators in approximately 40 children and adolescents aged between 7 and 18 years in Austrian inpatient or outpatient psychiatric health care institutions (without control group).
The data collection process will start with a baseline assessment on participants' general mental and physical health status, perceived stress, and coping with stress using standardized questionnaires. Subsequently, both salivary cortisol as well as self-reported stress and mood states of children and adolescents will be collected before and after each clown visit on a weekly basis over four consecutive weeks (pre-/post-test design). Saliva samples of cortisol are collected as a marker for the physiological stress response of participants. We will use Salicaps collection devices consisting of collection tubes and straws. Participants will be thoroughly instructed to collect accumulated saliva for two minutes without swallowing. After the two minutes, participants will transfer the accumulated saliva into the Salicap tube via the straw. Furthermore, self-reported stress levels and different dimensions of current mood states (good - bad mood; alertness - tiredness; calmness - restlessness) of children and adolescents are assessed by self-developed visual analogue scales and standardized questionnaires. In addition, representatives of the care staff at the health facilities will be asked to complete a questionnaire about their personal perception on the effects of clown visits on their own individual mood, the atmosphere within the care team, and the patients' well-being after each clown visit within the same time period of four weeks. The application of questionnaires is paper-based (paper-pencil). All data collected will be treated in a pseudonymized form.
Participants will be recruited from selected psychiatric health care facilities in Austria. The recruitment process of children and adolescents will be initiated by a briefing interview with the care staff at the relevant facilities. In this briefing, the staff will be informed in detail about the study goals and all data collection procedures and will have the opportunity to evaluate the participation of the children and adolescents independently (cf. eligibility criteria). No sensitive data will be shared with the research team at that point. The staff will further support in obtaining the written consent from parents or legal guardians prior to the start of data collection.
- Conditions
- Subjective Stress, Mood States, Physiological Stress
- Being tested
- Clown visits by RED NOSES Clowndoctors Austria
- Keywords
- Pilot Projects, Art Therapy, Healthcare clowning, Humour, Child, Adolescent, Psychiatric care, Outpatients, Inpatients, Stress, Psychological, Saliva, Arousal, Mental Health Services, Delivery of Health Care
- Medical subject headings
- Subjective Stress, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clown visits by RED NOSES Clowndoctors AustriaOther
Participants will receive one clown visit per week over four weeks in a group setting. The visits will take place in at least two different wards of each participating psychiatric care facility. In each ward, max. 10 participants will be targeted. The visits are carried out routinely by two professional clown artists from RED NOSES Clowndoctors Austria. The duration of the visits and the specific artistic sequences will take place according to internally organized routines. The essence of the clown visit is to catch the patient's attention proactively and reach the highest level of engagement possible. The specific artistic sequences are implemented spontaneously according to the situational atmosphere and current mood of participants. One clown visit will last between 1 and 2 hours depending on age and number of participants. Each participant will be engaged between 5 and 10 minutes by the clown. The clown artists are not involved in any study-related research activities.
| Study group | Role | What they receive |
|---|---|---|
| Clown visits (four times) | Experimental | Children and adolescents in psychiatric care participate in clown visits in a group setting on a weekly basis over four consecutive weeks. Receives: Other: Clown visits by RED NOSES Clowndoctors Austria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Stress
Subjective stress levels of children and adolescents will be assessed before as well as after each of the four clown visits by self-developed visual analogue scales (0-100 with higher scores indicating greater subjective stress).
Measured: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Subjective Mood
Subjective mood states (good - bad mood; alertness - tiredness; calmness - restlessness) of children and adolescents will be assessed before as well as after each of the four clown visits by an adapted and shorted version of the "Multidimensional Mood Questionnaire" (Steyer et al., 1997).
Measured: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Physiological Stress: Salivary Cortisol
Saliva samples of cortisol are collected as a marker for the physiological stress response of children and adolescents. Salivary cortisol reflects the activity of the HPA axis. Samples will be collected before as well as after each of the four clown visits. We will use Salicaps collection devices consisting of collection tubes and straws. Participants will be thoroughly instructed to collect accumulated saliva for two minutes without swallowing. After the two minutes, participants will transfer the accumulated saliva into the Salicap tube via the straw. Tubes are then stored at -20°C prior to analysis in the biochemical laboratory.
Measured: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Evaluation of Care Staff
Self-reported perceptions of care staff in the health facility will be assessed using a self-developed questionnaire about the effects of the clown visits on their own individual moods, the atmosphere within the care team, and the patients' well-being after each of the four clown visits.
Measured: Post-assessment: after each of the four interventions
Secondary outcomes (2)
Health-Related Quality of Life
Children's and adolescents' self-reported health-related quality of life will be assessed at baseline by the revised questionnaire "Health-Related Quality of Life" (German version; Ravens-Sieberer \& Bullinger, 1998).
Measured: Baseline (before intervention)
Internalizing and Externalizing Symptoms
Children's and adolescents' self-reported emotional and behavioral problems will be assessed at baseline by the relevant subscales of the questionnaire "Strengths and Difficulties Questionnaire" (German version; Klasen et al., 2000).
Measured: Baseline (before intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
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 Subjective StressStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using a non-controlled pre-/post-test design, the level of salivary cortisol and self-reported stress and mood will be measured before and after each clown visit on a weekly basis over four consecutive weeks.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- RED NOSES Clowndoctors Austria
- Responsible party
- Principal investigator, Martina Zemp, University of Vienna
- Investigators
- Zemp Martina, PhD, Principal investigator, University of ViennaSimone Seebacher, Mag., Study chair, RED NOSES Clowndoctors AustriaMaggie Rössler, PhD, Study chair, RED NOSES Clowndoctors AustriaUrs Nater, PhD, Study director, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844398
- Sponsor's protocol ID
- 00675
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data and syntaxes of this study will be made openly available in OSF Storage at https://osf.io/.
Publications
Zemp M, Friedrich AS, Holzmeier L, Seebacher S, Rossler M, Nater UM. Effects of clown visits on stress and mood in children and adolescents in psychiatric care-Protocol for a pilot study. PLoS One. 2022 Feb 18;17(2):e0264012. doi: 10.1371/journal.pone.0264012. eCollection 2022.
PubMed 35180260
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clown Visits by RED NOSES Clowndoctors Austria on Stress and Mood in Children and Adolescents in Psychiatric Care - A Pilot Study
- ClinicalTrials.gov ID
- NCT04844398
- Acronym / sponsor ID
- 00675
- Conditions
- Subjective Stress, Mood States, Physiological Stress
- Keywords
- Pilot Projects, Art Therapy, Healthcare clowning, Humour, Child, Adolescent, Psychiatric care, Outpatients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Collaborators
- RED NOSES Clowndoctors Austria
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 14 Apr 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.
This pilot study aims at investigating short-term effects of clown visits by RED NOSES Clowndoctors Austria in children and adolescents in psychiatric care without control group. It is assumed that children and adolescents involved in an interaction with the clowns will experience a shift in their focus. Individual attention and distraction from painful emotions have the ability to redirect their attention to the current pleasurable moment and increase their level of energy. Scientific evidence has shown that the distraction and switch to positive emotions associated with healthcare clowning can decrease the level of stress and pain (Vagnoli et al., 2005; Dionigi et al., 2014).
The study examines subjective and physiological stress levels of participants receiving clown visits in a group setting on a weekly basis. Using a non-controlled pre-/post-test design, the level of salivary cortisol and self-reported stress and mood will be measured before and after each clown visit over four consecutive weeks. Additionally, effects on care staff at the health facilities will be assessed based on a questionnaire after each clown visit within the same time period of four weeks. The sample will consist of approximately 40 children and adolescents in inpatient or outpatient psychiatric care. The examined intervention, i.e. clown visits by RED NOSES Clowndoctors Austria, is an integral part within the selected psychiatric health care institutions.
The study hypotheses are:
- Children and adolescents will report a reduced subjective stress level and better mood states in the three assessed dimensions (good - bad mood; alertness - tiredness; calmness - restlessness) after the experience of a clown visit (post-test) compared to before the clown visit (pre-test) independent of age and gender.
- Children and adolescents will display a reduced cortisol level after the experience of a clown visit (post-test) compared to before the clown visit (pre-test) independent of age and gender.
- The more frequently children and adolescents experience the weekly clown visits over the course of the four-week study, the stronger the stress-reducing and mood-enhancing effects in the pre-/post-comparison will be over time.
- Self-reported perceptions of care staff at the health facilities will indicate a positive effect of the clown visits on their own individual moods, the atmosphere within the care team, and the patients' well-being.
Detailed description
This pilot study will examine the effects of clown visits by RED NOSES Clowndoctors Austria on physiological and psychological stress indicators in approximately 40 children and adolescents aged between 7 and 18 years in Austrian inpatient or outpatient psychiatric health care institutions (without control group).
The data collection process will start with a baseline assessment on participants' general mental and physical health status, perceived stress, and coping with stress using standardized questionnaires. Subsequently, both salivary cortisol as well as self-reported stress and mood states of children and adolescents will be collected before and after each clown visit on a weekly basis over four consecutive weeks (pre-/post-test design). Saliva samples of cortisol are collected as a marker for the physiological stress response of participants. We will use Salicaps collection devices consisting of collection tubes and straws. Participants will be thoroughly instructed to collect accumulated saliva for two minutes without swallowing. After the two minutes, participants will transfer the accumulated saliva into the Salicap tube via the straw. Furthermore, self-reported stress levels and different dimensions of current mood states (good - bad mood; alertness - tiredness; calmness - restlessness) of children and adolescents are assessed by self-developed visual analogue scales and standardized questionnaires. In addition, representatives of the care staff at the health facilities will be asked to complete a questionnaire about their personal perception on the effects of clown visits on their own individual mood, the atmosphere within the care team, and the patients' well-being after each clown visit within the same time period of four weeks. The application of questionnaires is paper-based (paper-pencil). All data collected will be treated in a pseudonymized form.
Participants will be recruited from selected psychiatric health care facilities in Austria. The recruitment process of children and adolescents will be initiated by a briefing interview with the care staff at the relevant facilities. In this briefing, the staff will be informed in detail about the study goals and all data collection procedures and will have the opportunity to evaluate the participation of the children and adolescents independently (cf. eligibility criteria). No sensitive data will be shared with the research team at that point. The staff will further support in obtaining the written consent from parents or legal guardians prior to the start of data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using a non-controlled pre-/post-test design, the level of salivary cortisol and self-reported stress and mood will be measured before and after each clown visit on a weekly basis over four consecutive weeks.
| Arm | Type | Receives |
|---|---|---|
| Clown visits (four times) | Experimental | Other: Clown visits by RED NOSES Clowndoctors AustriaChildren and adolescents in psychiatric care participate in clown visits in a group setting on a weekly basis over four consecutive weeks. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being aged between 7 and 18 years;
- Currently being in inpatient or outpatient psychiatric treatment;
- Regularly participating in clown visits at the relevant health facility;
- A written consent of the child's legal guardian.
Key exclusion criteria (2 listed)
- Potential negative impacts of clown visits or study participation on participants' health or well-being according to medical or paramedical care staff of the relevant health facility;
- Insufficient command of German (for self-reports only).
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 |
|---|---|---|
| Clown visits by RED NOSES Clowndoctors AustriaParticipants will receive one clown visit per week over four weeks in a group setting. The visits will take place in at least two different wards of each participating psychiatric care facility. In each ward, max. 10 participants will be targeted. The visits are carried out routinely by two professional clown artists from RED NOSES Clowndoctors Austria. The duration of the visits and the specific artistic sequences will take place according to internally organized routines. The essence of the clown visit is to catch the patient's attention proactively and reach the highest level of engagement possible. The specific artistic sequences are implemented spontaneously according to the situational atmosphere and current mood of participants. One clown visit will last between 1 and 2 hours depending on age and number of participants. Each participant will be engaged between 5 and 10 minutes by the clown. The clown artists are not involved in any study-related research activities. | Other | Clown visits (four times) |
Primary outcome
Subjective Stress
Time frame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Subjective stress levels of children and adolescents will be assessed before as well as after each of the four clown visits by self-developed visual analogue scales (0-100 with higher scores indicating greater subjective stress).
Subjective Mood
Time frame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Subjective mood states (good - bad mood; alertness - tiredness; calmness - restlessness) of children and adolescents will be assessed before as well as after each of the four clown visits by an adapted and shorted version of the "Multidimensional Mood Questionnaire" (Steyer et al., 1997).
Physiological Stress: Salivary Cortisol
Time frame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
Saliva samples of cortisol are collected as a marker for the physiological stress response of children and adolescents. Salivary cortisol reflects the activity of the HPA axis. Samples will be collected before as well as after each of the four clown visits. We will use Salicaps collection devices consisting of collection tubes and straws. Participants will be thoroughly instructed to collect accumulated saliva for two minutes without swallowing. After the two minutes, participants will transfer the accumulated saliva into the Salicap tube via the straw. Tubes are then stored at -20°C prior to analysis in the biochemical laboratory.
Evaluation of Care Staff
Time frame: Post-assessment: after each of the four interventions
Self-reported perceptions of care staff in the health facility will be assessed using a self-developed questionnaire about the effects of the clown visits on their own individual moods, the atmosphere within the care team, and the patients' well-being after each of the four clown visits.
2 secondary outcomes
Health-Related Quality of Life
Time frame: Baseline (before intervention)
Internalizing and Externalizing Symptoms
Time frame: Baseline (before intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 35180260Zemp M, Friedrich AS, Holzmeier L, Seebacher S, Rossler M, Nater UM. Effects of clown visits on stress and mood in children and adolescents in psychiatric care-Protocol for a pilot study. PLoS One. 2022 Feb 18;17(2):e0264012. doi: 10.1371/journal.pone.0264012. eCollection 2022.
- Individual participant dataSharing planned: Yes. Anonymized data and syntaxes of this study will be made openly available in OSF Storage at https://osf.io/.
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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.
Zemp Martina, PhD principal investigator
University of Vienna
Simone Seebacher, Mag. study chair
RED NOSES Clowndoctors Austria
Maggie Rössler, PhD study chair
RED NOSES Clowndoctors Austria
Questions about this trial
What is this clinical trial studying?
A study testing Clown visits by RED NOSES Clowndoctors Austria in people with Subjective Stress and Mood States, run by University of Vienna.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zemp Martina, PhD (+431427747283, martina.zemp@univie.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Stress (time frame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)). The study lists 4 primary outcomes in all. 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 NCT04844398, 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 14 Apr 2021.