Music Therapy on State Anxiety Levels and Well-being During Chemotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClaudia Aristizábal
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who report having hearing problems.
Patients who express a desire not to participate in the study.
Patients with difficulties understanding and completing questionnaires.
Trial design
Design model
Parallel
Treatments tested in this trial
Live group music therapy
BehavioralThe 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Non-interventionNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and immediately after the interventionSecondary outcomes
1
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.
Time frame
Baseline and immediately after the interventionSponsors and contacts
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Claudia Aristizábal
Lead sponsor
Sanitas University
Sponsor institution
SONO
Collaborator
keralty
Collaborator
Clinica El Carmen
Collaborator
Clínica Sebastián de Belalcazar
Collaborator
Source ClinicalTrials.gov
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