The Effect of Music Therapy on Dyspnea Severity and Vital Signs

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Evaluation of The Effect of Music Therapy on Dyspnea Severity and Vital Signs In Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06358235
• Other study ID #: SDU-IH-HA-01
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Suleyman Demirel University
• Contact: Hafize Aydemir
• Phone: +905078380979
• Email: aydemirhafize1998[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of music therapy on dyspnea severity and quality of life indicators in patients with Chronic Obstructive Pulmonary Disease (COPD) admitted to the intensive care unit. The study will be conducted at Isparta City Hospital and Kumluca State Hospital in Antalya, Turkey, using an experimental design. Patients will be divided into experimental and control groups, selected using randomization.

Patients in the experimental group will receive music therapy in the Hüseyni maqam, while those in the control group will not receive any music therapy. Life indicators and Modified Borg Scale (MBS) values of patients in the experimental group will be recorded before, immediately after, and 30 minutes post-application. Music therapy will be administered to patients for only one day, once in the morning. Data for patients in the control group will be collected at the same time intervals. The results of this study aim to contribute to the literature on the impact of music therapy on dyspnea severity and quality of life indicators in COPD patients.

Description:

Intensive care is a multidisciplinary, professional field where patients with acute, life-threatening conditions or at risk of organ dysfunction are comprehensively managed. The primary goal of intensive care is to treat existing physical problems while maintaining the patient's physiological course and preventing deterioration. Perceiving breathing as strenuous and abnormal is defined as dyspnea. Assessing the severity of dyspnea is an important indicator for the progression of the disease. Dyspnea affects an individual's daily life, negatively impacting their ability to perform physical activities . Music therapy, as part of medical care, can be effectively used in the treatment of lung diseases and symptoms. It is enjoyable, cost-effective, and applicable almost anywhere . Music is reported to be effective as a pharmacological and non-invasive intervention in alleviating breathlessness .

The psychological and physical effects of music on humans have long been recognized. Music, by following a specific physiological pathway, can have various effects on the body, from reducing anxiety to lowering blood pressure and inducing relaxation. It is believed that negative thoughts and experiences can lead to physiological and psychological illness. Music is believed to have a profound impact on these illnesses .

There are limited studies in our country that investigate the effects of music therapy on patients admitted to intensive care with dyspnea complaints. In conclusion, dyspnea is a common problem among patients admitted to intensive care with a diagnosis of COPD. This study is planned to evaluate how music therapy affects dyspnea severity and life indicators in COPD patients admitted to intensive care. It is believed that the findings will contribute to the literature in terms of nursing care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being treated as a patient in intensive care.

• Being monitored with a diagnosis of COPD (Chronic Obstructive Pulmonary Disease).

• Currently undergoing treatment for dyspnea symptoms.

• Volunteering to participate in the research.

• Receiving treatment at Kumluca State Hospital.

• Receiving treatment at Isparta City Hospital.

• Being 18 years of age or older.

• Having intact consciousness and full capacity for judgment.

• Being able to read and write.

• Speaking Turkish.

• Having no communication barriers.

Exclusion Criteria:

• Decline participation in the research.

• Wish to withdraw from the study after it has started.

• Have a verbal communication barrier.

• Be under 18 years of age.

• Be receiving treatment in a unit other than intensive care.

• Have ear trauma, infection, or other ear-related conditions.

• Have hearing impairment.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Music Therapy
30-minute music therapy session.
• No Music therapy
The practice where patients are simply fitted with headphones and rest quietly without listening to music.

Locations

Country	Name	City	State
Turkey	Suleyman Demirel University	Isparta

Sponsors (1)

Lead Sponsor	Collaborator
Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Identification Form	The researcher has created a 12-question survey to determine patients' socio-demographic characteristics and health/medical history.	Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.
Primary	Modified Borg Scale	The Modified Borg Scale was initially developed by Borg in 1970. This scale was originally designed as a 6 to 20 rating scale to measure effort during physical activity. However, it was later modified into a 10-point system, including written indicators of severity. The Modified Borg Scale allows for the measurement of the severity of dyspnea (shortness of breath) in both resting and exertional states. It consists of a total of 10 items and enables patients to grade the severity of their dyspnea. Ratings are made on a scale from 0 to 10, where an increase in the number indicates an increase in dyspnea severity.; The availability and comprehensibility of this scale make it quite easy to administer to patients. Moreover, its superiority over other scales measuring dyspnea severity has been proven in long-term use. Implementing the Modified Borg Scale as a significant component of your research will help us objectively evaluate changes in patients' dyspnea severity.	Saving of values within 2 day. Evaluation of the data will take place within 3 months after the end of the study.
Primary	Vital Signs Record Chart	The chart was created by the researcher for recording the patient's blood pressure, pulse rate, respiratory rate, and saturation values.	Saving of values within 2 day. Evaluation of the data will take place within 3 months after the end of the study.
Primary	Blood Test Results Record Chart	The chart was created by the researcher for recording the patient's blood test results.	Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.