AnxietyECMONCNCT07886658
Effectiveness of a Music Therapy Intervention in Cancer Patients Undergoing Active Treatment at the Jaén University Hospital: a Non-randomized Controlled Trial.
A study testing Music Therapy in people with Anxiety and Signs and Symptoms, run by University of Jaén at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Signs and Symptoms, Oncologic Complications
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Spanish language skills
- Cognitive ability to understand the study
- Read and write skills.
Who cannot join
- Newcomers (first two sessions of active intravenous treatment)
- Patients who are administered non-protocol medication during the session
- Patients who experience complications during the course of the study that interfere with the development of the project.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Anxiety, Signs and Symptoms, Oncologic Complications
- Being tested
- Music Therapy
- Keywords
- cancer patients, music therapy, anxiety
- Medical subject headings
- Anxiety Disorders, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional active treatment | Active comparator | 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. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Through the STAI questionnaire, specifically the state anxiety part.
Measured: The questionnaire will be administered to participants before and after their active cancer treatment.
Secondary outcomes (1)
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.
Measured: The signs and symptoms questionnaire will be administered after completion of active cancer treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Apr 2025
- Primary completion1 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Jaen
- Responsible party
- Principal investigator, Belen Gutierrez Sanchez, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886658
- Sponsor's protocol ID
- ECMONC
- Acronym
- ECMONC
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Music Therapy Intervention in Cancer Patients Undergoing Active Treatment at the Jaén University Hospital: a Non-randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07886658
- Acronym / sponsor ID
- ECMONC / ECMONC
- Conditions
- Anxiety, Signs and Symptoms, Oncologic Complications
- Keywords
- cancer patients, music therapy, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- Hospital of Jaen
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional active treatment | Active comparator | Other: Music TherapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Spanish language skills
- Cognitive ability to understand the study
- Read and write skills.
Key exclusion criteria (3 listed)
- Newcomers (first two sessions of active intravenous treatment)
- Patients who are administered non-protocol medication during the session
- Patients who experience complications during the course of the study that interfere with the development of the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyFor 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. | Other | Conventional active treatment |
Primary outcome
Anxiety
Time frame: The questionnaire will be administered to participants before and after their active cancer treatment.
Through the STAI questionnaire, specifically the state anxiety part.
1 secondary outcome
Signs and symptoms
Time frame: The signs and symptoms questionnaire will be administered after completion of active cancer treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Anxiety and Signs and Symptoms, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: The questionnaire will be administered to participants before and after their active cancer treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.