Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577324
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Music Therapy on State Anxiety Levels and Well-being During Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None