RESUMO
BACKGROUND: Paediatric oncology/haematology patients and their families are confronted with a life-threatening situation for which music therapy can be a cross-linguistic field of action. The creative act of making music together offers the possibility to strengthen competences and make conflicts tangible. Besides its complementing of evidence-based biomedical care, there is little research on the feasibility and efficacy of interactive music therapy including the diagnosed child and their significant others. METHODS: We conducted an assessor blind, prospective, multicentric feasibility randomized controlled trial (RCT) with subsequent intervention. Including overall 52 child-significant other dyads, INMUT investigates interaction-focused music therapy with cancer-affected children and their significant others (INMUT-KB; n = 21) compared to music therapy only with the child (MUT-K; n = 21) and a wait-list group (WLG; n = 10). The measurement points include the screening for a cancer diagnosis, psychometric baseline (pre-T1), initial assessment (T1/T2), music therapy sessions (T3-T9), final assessment (T10), final psychometric evaluation (post-T10), and 3-month follow-up (cat-T11). Feasibility and acceptability of the (1) research methodology, (2) intervention and (3) estimation of effect sizes will be assessed using qualitative and quantitative data. The proposed primary outcome includes the parent-child interaction (APCI), and the proposed secondary outcomes refer to subjective goal achievement (GAS), quality of life (KINDL), system-related functional level (EXIS), psychosocial stress (BAS), psychosomatic complaints (SCL-9k), and resources (WIRF). We plan to investigate the efficacy of INMUT-KB and MUT-K post-intervention (post-T10) within the RCT design and at 3-month follow-up (cat-T11). DISCUSSION: This study will provide insights into the feasibility of INMUT and the final sample needed for a confirmatory RCT. We will reflect on successfully implemented study procedures and, if necessary, provide recommendations for changes considering the design, procedures, measures, and statistical analyses. The discussion will conclude with an evaluation whether a confirmatory RCT is worth the investment of future resources, including the calculated number of child-significant other dyads needed based on the efficacy trends derived from this feasibility study. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05534282; date of registration: June 23, 2022.
RESUMO
BACKGROUND: Music therapy is one of the oldest forms of creative art therapy and has been shown to have effects in different clinical and therapeutic settings, such as schizophrenia, pain, cardiovascular parameters, and dementia. This article provides an overview of some of the recent findings in this field and also reports two single case vignettes that offer insight into day-to-day applications of clinical music therapy. MATERIAL AND METHODS: For the collection of clinical studies of music therapy in oncology, the databases AMED, CAIRSS, EMBASE, MEDLINE, PsychINFO, and PSYNDEX were searched with the terms "Study OR Trial" AND "Music Therapy" AND "Cancer OR Oncolog$." Studies were analyzed with respect to their design, setting and interventions, indications, patients, and outcomes. In addition, two case vignettes present the application of music therapy for a child with leukemia and an adult patient with breast cancer. RESULTS: We found a total of 12 clinical studies conducted between 2001 and 2011 comprised of a total of 922 patients. Eight studies had a randomized controlled design, and four studies were conducted in the field of pediatric oncology. Studies reported heterogeneous results on short-term improvements in patients' mood and relaxation and reduced exhaustion and anxiety as well as in coping with the disease and cancer-related pain. Case descriptions showed similar effects in expressing emotions, opening up new goals, and turning the mind toward a healthy process and away form a disease-centered focus. CONCLUSION: The use of music therapy in the integrative treatment of cancer patients is a therapeutic option whose salutogenetic potential is shown in many case studies such as those presented here. Study results, however, did not draw a conclusive picture of the overall effect of music therapy. In addition to further clinical trials, the evidence mosaic should be complemented with qualitative studies, single case descriptions, and basic research.