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临床试验/NCT04844398
NCT04844398Unknown不适用

Effects of Clown Visits by RED NOSES Clowndoctors Austria on Stress and Mood in Children and Adolescents in Psychiatric Care - A Pilot Study

University of Vienna0 个研究点目标入组 40 人开始时间: 2021年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Evaluation of Care Staff

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evaluation of Care Staff

时间窗: 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.

Subjective Stress

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Internalizing and Externalizing Symptoms(Baseline (before intervention))
  • Health-Related Quality of Life(Baseline (before intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martina Zemp

Prof. Dr.

University of Vienna

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