Anxiety StateNCT06577324
Music Therapy on State Anxiety Levels and Well-being During Chemotherapy
A study testing Live group music therapy in people with Anxiety State and Well-Being, Psychological, run by Claudia Aristizábal at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety State, Well-Being, Psychological
- What is being tested?
- Live group music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteColombia
- Study dates
- 1 Sep 2024to 1 Sep 2025
- 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
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Colombia1 site
Clínica Colsanitas
Bogotá, Bogota D.C.
Mark Ettenberger, PhD, +57 311 2847635, mark.ettenberger@gmx.at
Raúl Suarez, MSc
About this study
Official title: Effect of a Single Session of Live Group Music Therapy on State Anxiety Levels and Well-being During Chemotherapy: A Multicenter Randomized Clinical 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.
Read more
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.
Read the 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?
- Conditions
- Anxiety State, Well-Being, Psychological
- Being tested
- Live group music therapy
- Keywords
- Anxiety, Well-Being, Music Therapy
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live group music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Live group music therapy Receives: Behavioral: Live group music therapy |
| Non-intervention | No intervention | Standard health care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and immediately after the intervention
Secondary 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.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety StateStudies 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- SONO, keralty, Clinica El Carmen, Clínica Sebastián de Belalcázar
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Mark Ettenberg, PhD, Principal investigator, SONO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577324
- Sponsor's protocol ID
- 062-24 UNV
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39737328
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Session of Live Group Music Therapy on State Anxiety Levels and Well-being During Chemotherapy: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06577324
- Acronym / sponsor ID
- 062-24 UNV
- Conditions
- Anxiety State, Well-Being, Psychological
- Keywords
- Anxiety, Well-Being, Music Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- SONO, keralty, Clinica El Carmen, Clínica Sebastián de Belalcázar
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Aug 2024 (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.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Live group music therapyLive group music therapy |
| Non-intervention | No intervention | –Standard health care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who report having hearing problems.
- Patients who express a desire not to participate in the study.
- Patients with difficulties understanding and completing questionnaires.
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 |
|---|---|---|
| Live group music therapyThe 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. | Behavioural | Intervention |
Primary outcome
State-trait Anxiety
Time frame: Baseline and immediately after the intervention
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.
1 secondary outcome
Wellbeing
Time frame: Baseline and immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Derived from this study: PubMed 39737328Reyes 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.
- 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.
Mark Ettenberg, PhD principal investigator
SONO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live group music therapy in people with Anxiety State and Well-Being, Psychological, run by Claudia Aristizábal at 1 site in Colombia.
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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Ettenberg, PhD (+57 311 2847635, mark.ettenberger@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-trait Anxiety (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577324, which also lists 1 linked publication.
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 29 Aug 2024.