DyspneaNCT06358235
The Effect of Music Therapy on Dyspnea Severity and Vital Signs
A study testing Music Therapy and No Music therapy in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Music Therapy and No Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2024to 30 Jun 2024
- 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
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demırel University
Isparta, 32200
Hafize Aydemir, +905078380979, aydemirhafize1998@gmail.com
About this study
Official title: Evaluation of The Effect of Music Therapy on Dyspnea Severity and Vital Signs In Intensive Care Patients
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.
Read the detailed 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.
- Conditions
- Dyspnea, Chronic Obstructive Pulmonary Disease
- Being tested
- Music Therapy, No Music therapy
- Keywords
- Music Therapy, Dyspnea, İntensive Care, Vital Signs
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
30-minute music therapy session.
No Music therapyOther
The practice where patients are simply fitted with headphones and rest quietly without listening to music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
The researcher has created a 12-question survey to determine patients' socio-demographic characteristics and health/medical history.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start7 Jan 2024
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafize Aydemir, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358235
- Sponsor's protocol ID
- SDU-IH-HA-01
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Music Therapy on Dyspnea Severity and Vital Signs In Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06358235
- Acronym / sponsor ID
- SDU-IH-HA-01
- Conditions
- Dyspnea, Chronic Obstructive Pulmonary Disease
- Keywords
- Music Therapy, Dyspnea, İntensive Care, Vital Signs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 10 Apr 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.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyThe 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. |
| No Music Therapy | Other | Other: No Music therapyWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Music Therapy30-minute music therapy session. | Other | Music Therapy |
| No Music therapyThe practice where patients are simply fitted with headphones and rest quietly without listening to music. | Other | No Music Therapy |
Primary outcome
Patient Identification Form
Time frame: Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.
The researcher has created a 12-question survey to determine patients' socio-demographic characteristics and health/medical history.
Modified Borg Scale
Time frame: Saving of values within 2 day. Evaluation of the data will take place within 3 months after the end of the study.
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.
Vital Signs Record Chart
Time frame: Saving of values within 2 day. Evaluation of the data will take place within 3 months after the end of the study.
The chart was created by the researcher for recording the patient's blood pressure, pulse rate, respiratory rate, and saturation values.
Blood Test Results Record Chart
Time frame: Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.
The chart was created by the researcher for recording the patient's blood test results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy and No Music therapy in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
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 11 inclusion and 7 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 10 Apr 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 Turkey (Türkiye). 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 Hafize Aydemir (+905078380979, aydemirhafize1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: Saving of values within 1 day. Evaluation of the data will take place within 3 months after the end of the study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.