Clinical trial NCT06577324: Music Therapy on State Anxiety Levels and Well-being During Chemotherapy
Official title: Effect of a Single Session of Live Group Music Therapy on State Anxiety Levels and Well-being During Chemotherapy: A Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety State
Well-Being, Psychological
Keywords: Anxiety
Well-Being
Music Therapy
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: SONO
name: keralty
name: Clinica El Carmen
name: Clínica Sebastián de Belalcazar
First posted: 2024-08-29
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Outpatient chemotherapy rooms are spaces where patients diagnosed with cancer receive their treatment. Chemotherapy poses a significant challenge for many patients and is associated with high levels of pain, anxiety, and depression. Several studies have shown that high levels of anxiety influence patients' physical symptoms, such as nausea and vomiting before and after treatment, revealing that 60% of patients undergoing chemotherapy experience these symptoms. These anxiety levels also affect the activation of the sympathetic nervous system, the release of norepinephrine and adrenaline, and an increase in heart rate, respiratory rate, and blood pressure. For many patients, chemotherapy also disrupts social relationships, generates feelings of hopelessness and emotional vulnerability, and causes a rupture and imbalance in all vital dimensions. Additionally, patients with symptoms of depression and anxiety perceive the side effects of chemotherapy more intensely, which significantly impacts their quality of life. This is crucial because it highlights that the patient's mental health and well-being directly influence the course of their illness and their ability to tolerate treatment.

Furthermore, secondary factors such as waiting times both in waiting rooms and within the chemotherapy room can also generate fear, uncertainty, anxiety, discomfort, anger, and irritability. Notably, the environment of the room, filled with different types of noises and sounds, can also affect the mental health of patients.

Due to all of the above, there is a need to explore new strategies to support the chemotherapy process and improve patients' quality of life. Music therapy is one of these strategies, and preliminary evidence suggests it may reduce anxiety symptoms and positively impact the side effects of chemotherapy. Listening to and performing music has a direct effect on the limbic system and can help lower cortisol levels and increase endorphin production.

This research proposal aims to determine the effect of group music therapy on the state anxiety levels and well-being of adult oncology patients attending the chemotherapy rooms at the Sebastián de Belalcázar Clinic in Cali and the El Carmen Clinic in Barranquilla.

Research Question: What is the effect of a single live group music therapy intervention on the state anxiety levels and well-being of adult patients with any type of oncological condition during chemotherapy at the Sebastián de Belalcázar Clinic and the El Carmen Clinic?

Eligibility criteria: Inclusion Criteria:

* Patients with a cancer diagnosis, attending intravenous chemotherapy sessions at the Sebastián de Belalcázar and del Carmen clinics.
* Patients over 18 years old.
* Patients who have never previously received music therapy.
* Patients with literacy skills.

Exclusion Criteria:

* Patients who report having hearing problems.
* Patients who express a desire not to participate in the study.
* Patients with difficulties understanding and completing questionnaires.

Primary outcomes:
measure: State-trait Anxiety
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Wellbeing
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Clínica Colsanitas
state: Bogotá D.C.
Study officials:
affiliation: SONO
name: Mark Ettenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: