Music Therapy on State Anxiety Levels and Well-being During Chemotherapy
NCT Number: NCT06577324
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety State|Well-Being, Psychological
Interventions: BEHAVIORAL: Live group music therapy
Sponsor: Claudia Aristizábal
Collaborators: SONO|keralty|Clinica El Carmen|Clínica Sebastián de Belalcazar
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 102
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01
Locations: Clínica Colsanitas, Bogotá, Bogotá D.C., Colombia

Summary:
Introduction: Many cancer patients experience high levels of anxiety during chemotherapy, which can negatively impact their mental health and physiological, emotional, and spiritual well-being. Various complementary therapies exist to mitigate these effects, including music therapy. Although preliminary evidence supports the positive effects of music therapy and music-based interventions in chemotherapy, few studies report live group interventions conducted by accredited music therapists.

Objective: To determine the effect of a single session of live group music therapy on state anxiety levels and well-being in adult cancer patients undergoing chemotherapy.

Methodology: This study is a multicenter, randomized clinical trial with two arms. The intervention group will receive standard care plus a live group music therapy session, while the control group will receive standard care only. The primary outcome measure is the State-Trait Anxiety Inventory (STAI-E), and the secondary outcome measure is well-being, assessed using the Well-being Numerical Rating Scales (WB-NRSs). The scales will be administered before and after each intervention. The sample size is 102 patients.

Expected Results: This study aims to improve the psycho-emotional health and well-being of cancer patients during chemotherapy, thereby enhancing the quality of care.

Primary Outcome Measures: State-trait Anxiety, State-trait Anxiety will be assessed pre and post intervention. To measure state anxiety levels, the STAI (State-Trait Anxiety Inventory) scale will be used. This scale consists of 40 items scored using a Likert scale with four response options (0-3). Twenty items measure trait anxiety (STAI-T) and the other twenty measure state anxiety (STAI-S). Due to the nature of this study, only state anxiety levels will be measured. The Spanish version of the scale has been validated, with a Cronbach's alpha internal consistency ranging from 0.9 to 0.93, and it has demonstrated adequate reliability and validity. The STAI-S will be administered before and after each intervention., Baseline and immediately after the intervention
Secondary Outcome Measures: Wellbeing, To measure well-being levels, the WB-NRSs (The Well-Being Numerical Rating Scales) will be used. These scales assess well-being across five different dimensions: physical, psychological, social, spiritual, and general well-being. Each of these domains is measured using a visual analog scale with a score ranging from 1 to 10. The Spanish validation is currently in publication. The WB-NRSs will be administered before and after each intervention., Baseline and immediately after the intervention