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Effects of clown intervention on the psychological stress and fatigue in children and adolescents with cancer receiving chemotherapy

Correlations between immunological biomarkers and response to fatigue and psychological stress in children and adolescents with cancer undergoing chemotherapy submitted to clown intervention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2gykb2
Enrollment
Unknown
Registered
2016-07-14
Start date
2015-08-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neoplasms. fatigue. stress, psychological.

Interventions

Experimental group: 40 children and adolescents aged 2 to 18 years
diagnosed with malignant neoplasm receiving chemotherapy during the collection of biological material (saliva)
and submitted to clown intervention Control group: 40 healthy children and adolescents aged 2 to 18 years
with no history of chronic disease / autoimmune / psychiatric disease
in followed up in one of the 5 Family Health Unitis, and presenting recent normal blood count
and without being submitted to clown intervention
Behavioural
Other
F04.754.137

Sponsors

Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: Experimental group;Children and adolescents aged 2 to 18 years; of both sexes; diagnosed with malignant neoplasm; in any phase of chemotherapy; who present conscious, able to communicate verbally, reading and writing; Control group;Children and adolescents aged 2 to 18 years; with no history of chronic disease or autoimmune disease or psychiatric illness; followed up in one of the 5 Family Health Unitis; not be receiving medication at the time of selection or collection of biological samples; who present conscious, able to communicate verbally, reading and writing; presenting recent blood count data in normal levels;

Exclusion criteria

Exclusion criteria: Experimental group;Patients with a history of chronic disease or autoimmune disease or psychiatric disease; patients receiving radiotherapy; patients in palliative care; patients using antidepressants or drugs which altering the mood; patients with clownfobia; patients with infectious conditions in activity; patients in the immediate postoperative period; Control group;Children and adolescents with infectious conditions in course; presence of fever in the last 48 hours; in use of systemic corticosteroids, inhaled or topical in the last 15 days;

Design outcomes

Primary

MeasureTime frame
Decrease of stress levels and cancer-related fatigue after the clown intervention, verified by changes in the circadian rhythm of cortisol, alpha-amylase and pro inflammatory cytokines, from the observation of a range of at least 5% in the pre and post intervention measurements.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactLuís Lopes Júnior

Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo

lopesjr.lc@gmail.com+5516981793043

Outcome results

None listed

Source: REBEC (via WHO ICTRP)