An interventional study of Music Therapy in Anxiety, Signs and Symptoms and Oncologic Complications, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Jaén · Not applicable, Interventional, and Treatment
A cancer diagnosis and its clinical progression can cause patients physical, psychological, emotional, social, and spiritual distress. This often requires the administration of active treatments, which are sometimes associated with spending long periods of time in the Medical Oncology Unit, resulting in a detrimental impact on their quality of life. A growing number of studies certify the benefits of music therapy, where the application of live music generates a change in the perception of the care management of the oncological process. We aim to create a climate of well-being in the Medical Oncology Day Hospital by hosting live music sessions during treatment administration. The objectives are: to analyze the effectiveness of a music therapy session in reducing stress in patients undergoing active cancer treatment, to analyze the effectiveness of a music therapy session in reducing anxiety symptoms in patients undergoing active cancer treatment, to analyze the effectiveness of a music therapy session in reducing depression symptoms in patients undergoing active cancer treatment, and to analyze the effectiveness of a music therapy session on the feeling of duration of the treatment session and in reducing treatment-related symptoms in patients undergoing active cancer treatment. A non-randomized controlled trial with two parallel arms with pre-post measurement will be conducted in patients with active intravenous cancer treatment received at the day hospital of the University Hospital of Jaén.
Objectives:
To analyze the effectiveness of a music therapy session in reducing stress in patients undergoing active cancer treatment.
To analyze the effectiveness of a music therapy session in reducing anxiety symptoms in patients undergoing active cancer treatment.
To analyze the effectiveness of a music therapy session in reducing depression symptoms in patients undergoing active cancer treatment.
To analyze the effectiveness of a music therapy session on the perceived duration of the treatment session and the reduction of treatment-related symptoms in patients undergoing active cancer treatment.
Design A two-arm, parallel-arm, non-randomized controlled trial with pre-post measurement.
Reference Population Patients receiving active intravenous cancer treatment at the day hospital of the Jaén University Hospital.
Inclusion Criteria:
Over 18 years of age Spanish language skills Cognitive ability to understand the study Read and write skills
Exclusion Criteria:
Newcomers (first two sessions of active intravenous treatment) Patients who are administered medication outside the protocol during the session.
Patients who, during the course of the study, experience complications that interfere with the development of the project.
For these last two, we must have one or two nursing staff who will inform us of any patients who are administered any type of medication or who experience any complications.
Ask Rocio Boyer to recruit this staff.
Sampling:
Convenience and consecutive sampling will be used. A total sample of at least 120 participants is required, 60 per group.
Independent Variables:
Intervention (independent): 1 music therapy session that coincides with the duration of the active oncology treatment session.
Control group: People receiving regular care who have not received music therapy.
Outcomes (dependent):
Stress: measured using the Perceived Stress Scale (PSS), which consists of 14 items Anxiety and depression symptoms: measured using the Goldberg Anxiety and Depression Scale, which contains two subscales with nine questions each: anxiety subscale (questions 1-9) and depression subscale (questions 10-18) Questionnaire on treatment-related symptoms and perceptions of treatment duration: developed ad hoc for this research by the authors of this protocol. Since each item in this questionnaire will be treated as a variable, only expert content validation is required. This validation was performed by five experts in research methodology and/or active cancer treatment; all items exceeded 95% agreement.
Potential confounding variables: Session duration, age, sex, and ECOG quality of life scale for cancer patients
DATA COLLECTION AND INFORMATION SOURCES.
Recruitment, information about the study, the proposal for acceptance, and the signing of the informed consent form will be carried out by the research team for prospective participants.
Since it is impossible to blind participants to their membership in the experimental group (single-blind), the hypotheses will be withheld from the participants, so they will not know the ultimate purpose of the study. The pre-consent information and the consent form will state that the purpose of this study is to assess their experience and feelings during the treatment session.
Data collection will be carried out at the day hospital by researchers who are not part of the team responsible for treating the patients. Two measurements will be taken: 1) Pre: prior to the treatment session; the following will be collected: stress, anxiety and depression symptoms, age, sex, and ECOG scale; 2) Post: at the end of the treatment session; the following will be collected: stress, anxiety and depression symptoms, an ad hoc questionnaire, and the duration of the session.
The questionnaires will be self-administered. This mitigates the fact that data collection cannot be blinded to the researchers responsible for it.
Data collection from participants in the control group will take place the day before or after the experimental group.
DATA ANALYSIS
Descriptive analysis will be performed by calculating frequencies, measures of central tendency and dispersion, 95% confidence intervals, and standard deviations.
Bivariate analysis for comparison between groups at baseline will be performed using differences in means (Student's t test or Mann-Whitney U test, depending on whether the conditions for the Student's t test are met) or percentages (chi-square test).
For the outcomes of stress and anxiety and depression symptoms, the effectiveness of the intervention will be analyzed using a mixed ANCOVA (within-group factor: time; between-group factor: treatment), including potential confounding variables as covariates in the model.
For the ad hoc questionnaire results, effectiveness will be analyzed using multiple linear regression analysis (RegLin) for items with a visual analogue or Likert-type scale (which will be treated as discrete quantitative variables) or multiple binary logistic regression (RegLog) for items with dichotomous measurement. In both cases (RegLin and RegLog), each model will consist of the treatment group variable and potential confounding variables.
The intervention effect size will be measured using Eta squared (η2) in the ANCOVA, standardized regression coefficient (β) in the RegLin, and odds ratio (OR) in the RegLog.
Data analysis will be blinded by assigning a code to each group in the results database, the meaning of which will not be shared with the researcher in charge of data analysis.
DIFFICULTIES AND LIMITATIONS OF THE STUDY The impossibility of randomly assigning participants to the experimental and control groups, which will be controlled through stratified sampling and statistical adjustment for potential confounding variables.
Convenience sampling, which, along with the lack of randomization, increases the risk of selection bias. This is attempted to be controlled with consecutive sampling (the least harmful of non-probability sampling methods) and by controlling for confounding variables.
The impossibility of single-blind masking, which is controlled by concealing hypotheses from participants.
The impossibility of blinding researchers during data collection, which will be controlled with the use of self-administered questionnaires.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 120 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Jaén is the lead sponsor of 81 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The control group participants will be patients undergoing conventional active oncology treatment at the Jaén University Hospital Day Hospital. They will receive their usual oncology treatment on different dates than the intervention.
Other: Music Therapy
For the World Federation of Music Therapy (WFMT), "music therapy is the professional use of music and its elements as an intervention in medical, educational, and everyday settings with individuals, groups, families, or communities seeking to optimize their quality of life and improve their physical, social, communicative, emotional, intellectual, and spiritual health and well-being." Since 2000, the WHO (World Health Organization) has recommended music therapy as a complementary therapy in healthcare. In the hospital setting, it offers the advantages of flexibility, affordability, lack of side effects, and compatibility with medical treatments.
Anxiety
Through the STAI questionnaire, specifically the state anxiety part.
Time frame: The questionnaire will be administered to participants before and after their active cancer treatment.
Signs and symptoms
Since each item in the questionnaire will be treated as a variable, only expert content validation is required. This validation was performed by five experts in research methodology and/or active cancer treatment, and all items exceeded 95% agreement.
Time frame: The signs and symptoms questionnaire will be administered after completion of active cancer treatment.
Potential confounding variables
Session duration, age, sex, and ECOG quality of life scale for cancer patients
Time frame: Potential confounding variables will be measured before active cancer treatment
Plan to share: No
Ran from Apr 2025 to primary completion in Sep 2026, 17 months.
Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 17 months is above that.
Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Jaén