Music Therapy on State Anxiety Levels and Well-being During Chemotherapy

Effect of a Single Session of Live Group Music Therapy on State Anxiety Levels and Well-being During Chemotherapy: A Multicenter Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety State; Well-Being, Psychological
• Intervention / Treatment: Behavioral: Live group music therapy

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?

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Ettenberg, PhD; Phone Number: +57 311 2847635; Email: mark.ettenberger@gmx.at

Study Locations

• Colombia
  • Bogotá D.C.
    • Bogotá, Bogotá D.C., Colombia
      • Clínica Colsanitas
      • Contact: Mark Ettenberger, PhD; Phone Number: +57 311 2847635; Email: mark.ettenberger@gmx.at
      • Principal Investigator: Raúl Suarez, MSc
      • Principal Investigator: Laura Reyes, MSc
      • Principal Investigator: Ana Diaz, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Live group music therapy	Behavioral: Live group music therapy; The intervention will involve the use of live music in a group of patients during their quimiotherapy session. The intervention will last approximately forty minutes and will be organized into three stages: Opening (10 min), Body Awareness and Movement (7-10 minutes), Intervention Development (20 minutes). Genres and songs are performed based on the group's preferences and suggestions. The instruments used for the group intervention are the same as those mentioned earlier; participants are provided with percussion instruments, accompanied by the music therapist's voice and the participants' voices. The intervention encourages active participation, with users playing the instruments, singing, engaging in dialogue, and/or reflecting between songs.
No Intervention: Non-intervention; Standard health care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Claudia Aristizábal
• Collaborators: SONO; keralty; Clinica El Carmen; Clínica Sebastián de Belalcazar
• Investigators: Principal Investigator: Mark Ettenberg, PhD, SONO

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Music Therapy; Well-Being
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 062-24 UNV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No