Clown Visits in Child and Adolescent Psychiatry

NCT04844398 | Unknown

• 1 other identifier: 00675
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  Post-assessment: after each of the four interventions

Secondary Outcomes (2)

• Health-Related Quality of Life

  Baseline (before intervention)

• Internalizing and Externalizing Symptoms

  Baseline (before intervention)

Study Arms (1)

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.

Other: Clown visits by RED NOSES Clowndoctors Austria

Interventions

Clown visits by RED NOSES Clowndoctors Austria OTHER

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.

Clown visits (four times)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Vienna: lead
• RED NOSES Clowndoctors Austria: collaborator

Related Publications (1)

• 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.

  PMID: 35180260 DERIVED

MeSH Terms

Conditions

Subjective Stress; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Zemp Martina, PhD

  University of Vienna

  PRINCIPAL INVESTIGATOR

• Simone Seebacher, Mag.

  RED NOSES Clowndoctors Austria

  STUDY CHAIR

• Maggie Rössler, PhD

  RED NOSES Clowndoctors Austria

  STUDY CHAIR

• Urs Nater, PhD

  University of Vienna

  STUDY DIRECTOR

Central Study Contacts

Zemp Martina, PhD

CONTACT

+431427747283; martina.zemp@univie.ac.at

Simone Seebacher, Mag.

CONTACT

+431318031357; simone.seebacher@rotenasen.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol including the SAP will become available before the start of data collection.