Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315049
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-01-05
Brief Title:
Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness
Sponsor:
Universitat Politècnica de València
Organization:
Universitat Politècnica de València
Study Overview
Official Title:
Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness SMI bipolar disorder and schizophrenia The intervention was structured over five weeks ten 1-hour sessions twice weekly Objective measures blood pressure heart rate and respiratory rate and subjective measures anxiety response and the subjective perception of relaxation were taken before and after every session
Detailed Description:
This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with SMI bipolar disorder and schizophrenia
The general objective is to evaluate the effectiveness of the Nursing Interventions Classification NIC activity known as Music Therapy as a therapeutic modality complementary to psychopharmacological treatment for reducing anxiety in patients diagnosed with SMI The specific research questions are
Q1 How much do music interventions affect the objective values of vital signs systolic blood pressure SBP diastolic blood pressure DBP heart rate HR and respiratory rate RR in people diagnosed with SMI Q2 How much does the subjective perception of anxiety change after a music intervention with people diagnosed with SMI This pilot study is quasi-experimental analytical research of type cross-sectional It was conducted with outpatients diagnosed with SMI All patients were recruited from a community mental health center in Valencia Spain Fourteen patients regularly attended an occupational activities rehabilitation workshop All of them were recruited after the workshop they participated in the music therapy sessions All the participants had been previously diagnosed with SMI schizophrenia bipolar disorder by their psychiatrist Ten participants lived with their parents and four lived alone and lacked familiar support None of the participants worked All had total permanent disability legally granted and therefore could not carry out any work activity
All patients who met the inclusionexclusion criteria and voluntarily accepted to participate were recruited 14 patients 3 people with bipolar disorder 11 people with schizophrenia participated in the study with a total sample of 10 group sessions and 150 individual data collection interviews None of the patients had any previous music therapy experience All patients followed unique treatments and this study was an opportunity to motivate their social interaction through music and to study its impact on anxiety
The patients psychiatrists determined the cognitive competency of the patients and decided the convenience of their participation
The intervention was organized into ten 1-hour music therapy sessions at the outpatient level twice weekly Patients adherence to the music therapy sessions was 75 which was more or less stable standard deviation 15
The general objective is to evaluate the effectiveness of the Nursing Interventions Classification NIC activity known as Music Therapy as a therapeutic modality complementary to psychopharmacological treatment for reducing anxiety in patients diagnosed with SMI The specific research questions are
Q1 How much do music interventions affect the objective values of vital signs systolic blood pressure SBP diastolic blood pressure DBP heart rate HR and respiratory rate RR in people diagnosed with SMI Q2 How much does the subjective perception of anxiety change after a music intervention with people diagnosed with SMI This pilot study is quasi-experimental analytical research of type cross-sectional It was conducted with outpatients diagnosed with SMI All patients were recruited from a community mental health center in Valencia Spain Fourteen patients regularly attended an occupational activities rehabilitation workshop All of them were recruited after the workshop they participated in the music therapy sessions All the participants had been previously diagnosed with SMI schizophrenia bipolar disorder by their psychiatrist Ten participants lived with their parents and four lived alone and lacked familiar support None of the participants worked All had total permanent disability legally granted and therefore could not carry out any work activity
All patients who met the inclusionexclusion criteria and voluntarily accepted to participate were recruited 14 patients 3 people with bipolar disorder 11 people with schizophrenia participated in the study with a total sample of 10 group sessions and 150 individual data collection interviews None of the patients had any previous music therapy experience All patients followed unique treatments and this study was an opportunity to motivate their social interaction through music and to study its impact on anxiety
The patients psychiatrists determined the cognitive competency of the patients and decided the convenience of their participation
The intervention was organized into ten 1-hour music therapy sessions at the outpatient level twice weekly Patients adherence to the music therapy sessions was 75 which was more or less stable standard deviation 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None