Clinical trial · Interventional
Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects
Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this interventional study is to evaluate the impact of Hospital Clowns (HCs) intervention, besides to hospital hosting conditions, in the well-being of adult female patients during ambulatory chemotherapy. The main question\[s\] it aims to answer are: * Do the short-term HCs interventions during ambulatory chemotherapy may increase well-being of adult cancer patients in comparison to the hospital hosting conditions? * Do the short-term HCs interventions, besides the hospital hosting conditions, have effects on well-being biomarkers in association with psychological outcomes? Participants self-collect a sample of saliva followed by psychological assessment, at a first time-point (basal) and at a final time-point (\~after 90 minutes of basal) (pre- and post-test), during the chemotherapy treatment session. Researchers have compared an HCs intervention plus hosting conditions - experimental group, EG, and hosting conditions only - control group, CG, by the repeated measures of pre- and post-test of biomarkers in saliva and the psychological functioning evaluations, to see the degree of the impact of HCs intervention in the well-being of the patients in comparison with normal hosting conditions. Each HCs intervention lasts around 15 minutes, and it is performed in the middle of the procedure between pre- and post-test.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ambulatory Care | — | UNRESOLVED | — |
| Biomarkers | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Complementary Therapies | — | UNRESOLVED | — |
| Well-Being, Psychological | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hospital Clowns | Other | — | UNRESOLVED |
| Hosting conditions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control Group (CG)
- description
- Control Group participants were exposed to the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.
- interventionNames
- Other: Hosting conditions
- type
- EXPERIMENTAL
- label
- Experimental Group (EG)
- description
- Experimental Group participants were exposed to the Hospital Clowns intervention plus the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.
- interventionNames
- Other: Hosting conditions
- Other: Hospital Clowns
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women with cancer undergoing chemotherapy in the ambulatory hospital Exclusion Criteria: * Patients with head and neck cancer * Having their first or last chemotherapy session * Receiving chemotherapy orally or via lumbar puncture * Presenting with any cognitive or language impairment that would prevent their understanding of the study and assessment or that could predictably interfere the levels of biomarkers evaluated
References
Publications (15)
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- BACKGROUNDGalinha, I.C., Pereira, C.R., Esteves, F., 2014. Versão reduzida da escala portuguesa de afeto positivo e negativo - PANAS-VRP: Análise fatorial confirmatória e invariância temporal [Short-Form of the Portuguese version of the positive and negative affect schedule - PANAS-Port-VRP: Confirmatory factorial analysis and temporal invariance]. Psicologia. 28 (1), 53-65. http://scielo.pt/scielo.php?script=sci_arttext&pid=S0874-20492014000100005&lng=pt&tlng=pt.
- BACKGROUNDTeixeira, R.J., Ferreira, G., Pereira, M.G., 2017. Portuguese validation of the Cognitive and Affective. Mindfulness & Compassion. 2, 3-8. https://doi.org/10.1016/J.MINCOM.2017.03.001.
- BACKGROUNDSantana I, Duro D, Freitas S, Alves L, Simoes MR. The Clock Drawing Test: Portuguese norms, by age and education, for three different scoring systems. Arch Clin Neuropsychol. 2013 Jun;28(4):375-87. doi: 10.1093/arclin/act016. Epub 2013 Mar 21. PMID 23518874
- BACKGROUNDCasellas-Grau A, Ochoa C, Lleras De Frutos M, Flix-Valle A, Rosales A, Gil F. Perceived changes in psychological and physical symptoms after hospital clown performances in a cancer setting. Arts Health. 2021 Jun;13(2):189-203. doi: 10.1080/17533015.2020.1744172. Epub 2020 Mar 29. PMID 32223531
- BACKGROUNDFerreira AC, Osorio FL. Peripheral oxytocin concentrations in psychiatric disorders - A systematic review and methanalysis: Further evidence. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jul 13;117:110561. doi: 10.1016/j.pnpbp.2022.110561. Epub 2022 Apr 21. PMID 35461971
- BACKGROUNDChojnowska S, Ptaszynska-Sarosiek I, Kepka A, Knas M, Waszkiewicz N. Salivary Biomarkers of Stress, Anxiety and Depression. J Clin Med. 2021 Feb 1;10(3):517. doi: 10.3390/jcm10030517. PMID 33535653