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

Not Applicable

Recruiting

• Conditions: neoplasms. fatigue. stress, psychological.; C23.888.369; F01.145.126.990

• Registration Number: RBR-2gykb2
• Lead Sponsor: Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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;

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary outcomes are not expected