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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06577324
Enrollment
102
Registered
2024-08-29
Start date
2024-09-01
Completion date
2025-09-01
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Well-Being, Psychological

Keywords

Anxiety, Well-Being, Music Therapy

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?

Interventions

BEHAVIORALLive 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.

Sponsors

SONO
CollaboratorUNKNOWN
keralty
CollaboratorUNKNOWN
Clinica El Carmen
CollaboratorUNKNOWN
Clínica Sebastián de Belalcazar
CollaboratorUNKNOWN
Claudia Aristizábal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
State-trait AnxietyBaseline and immediately after the interventionState-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.

Secondary

MeasureTime frameDescription
WellbeingBaseline and immediately after the interventionTo 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.

Countries

Colombia

Contacts

Primary ContactMark Ettenberg, PhD
mark.ettenberger@gmx.at+57 311 2847635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026