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

NCT06577324 | Not Yet Recruiting

• 1 other identifier: 062-24 UNV
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety State; Well-Being, Psychological

Keywords

Anxiety; Well-Being; Music Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wellbeing

  Baseline and immediately after the intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Live group music therapy

Behavioral: Live group music therapy

Non-intervention

NO INTERVENTION

Standard health care

Interventions

Live group music therapy BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Claudia Aristizábal: lead
• SONO: collaborator
• keralty: collaborator
• Clinica El Carmen: collaborator
• Clínica Sebastián de Belalcazar: collaborator

Study Sites (1)

Clínica Colsanitas

Bogotá, Bogota D.C., Colombia

Location

Related Publications (1)

• Reyes Aragon L, Diaz AM, Suarez R, Amarillo MA, Colmenares Mejia CC, Ettenberger M. Effect of a Single Live Group Music Therapy Intervention on Anxiety-State and Well-Being Levels During Chemotherapy: A Multicenter Randomized Clinical Trial Protocol. Glob Adv Integr Med Health. 2024 Dec 26;13:27536130241310241. doi: 10.1177/27536130241310241. eCollection 2024 Jan-Dec.

  PMID: 39737328 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Mark Ettenberg, PhD

  SONO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Ettenberg, PhD

CONTACT

+57 311 2847635; mark.ettenberger@gmx.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)