The Effect of Music Therapy on Dyspnea Severity and Vital Signs

NCT06358235 | Recruiting DMC

• 1 other identifier: SDU-IH-HA-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyspnea; Chronic Obstructive Pulmonary Disease

Keywords

Music Therapy; Dyspnea; İntensive Care; Vital Signs

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Music Therapy

EXPERIMENTAL

The Patient Identification Form, Modified Borg Scale, Vital Signs Record Chart, and Blood Test Results Record Chart will be completed when the patient is first admitted to the ward. Music therapy intervention will be administered between 6:00 AM and 12:00 PM. Before the music therapy session, the patient will lie on their back at a 30-45 degree angle and rest for 5 minutes. The Modified Borg Scale and Vital Signs Record Chart will be completed just before the music therapy session begins. During the session, the patient will receive the music therapy intervention through headphones for 30 minutes. At the end of the 30-minute music session, the Modified Borg Scale and Vital Signs Record Chart will be completed again. Thirty minutes after the end of the music therapy intervention, the Modified Borg Scale and Vital Signs Record Chart will be completed once more.

Other: Music Therapy

No Music Therapy

OTHER

When the patient is admitted to the ward, the Patient Identification Form, Modified Borg Scale, Vital Signs Record Chart, and Blood Test Results Record Chart will be completed. Music therapy will not be applied to this group; however, patients will be provided with headphones to maintain consistent conditions. When the patient is ready, between 6:00 AM and 12:00 PM, they will lie on their back at a 30-45 degree angle and rest for 5 minutes. The Modified Borg Scale and Vital Signs Record Chart will be completed just before the patient puts on the headphones. Once the session begins, the patient will quietly spend 30 minutes with headphones. After 30 minutes, the Modified Borg Scale and Vital Signs Record Chart will be filled out again. Thirty minutes after the end of the session, the Modified Borg Scale and Vital Signs Record Chart will be completed again.

Other: No Music therapy

Interventions

Music Therapy OTHER

30-minute music therapy session.

Music Therapy

No Music therapy OTHER

The practice where patients are simply fitted with headphones and rest quietly without listening to music.

No Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demırel University

Isparta, 32200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Hafize Aydemir

CONTACT

+905078380979; aydemirhafize1998@gmail.com

Kamuran Cerit

CONTACT

+905336199839; kamurancerit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 10, 2024
• Study Start: January 7, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)