Clinical trial NCT04844398: Clown Visits in Child and Adolescent Psychiatry
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Stress
Mood States
Physiological Stress
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
Lead sponsor: University of Vienna
Sponsor class: OTHER
Collaborators: name: RED NOSES Clowndoctors Austria
First posted: 2021-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility criteria: Inclusion criteria:

1. Being aged between 7 and 18 years;
2. Currently being in inpatient or outpatient psychiatric treatment;
3. Regularly participating in clown visits at the relevant health facility;
4. A written consent of the child's legal guardian.

Exclusion criteria:

1. 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;
2. Insufficient command of German (for self-reports only).

Primary outcomes:
measure: Subjective Stress
timeFrame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
measure: Subjective Mood
timeFrame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
measure: Physiological Stress: Salivary Cortisol
timeFrame: Pre-Post-Change: Change from before to immediately after intervention for four times (over four weeks)
measure: Evaluation of Care Staff
timeFrame: Post-assessment: after each of the four interventions
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline (before intervention)
measure: Internalizing and Externalizing Symptoms
timeFrame: Baseline (before intervention)
Other outcomes:
Locations:
Study officials:
affiliation: University of Vienna
name: Zemp Martina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RED NOSES Clowndoctors Austria
name: Simone Seebacher, Mag.
role: STUDY_CHAIR
affiliation: RED NOSES Clowndoctors Austria
name: Maggie Rössler, PhD
role: STUDY_CHAIR
affiliation: University of Vienna
name: Urs Nater, PhD
role: STUDY_DIRECTOR
References:
citation: 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.