HealthyNCT06293248
Music Application in Patients Undergoing Percutaneous Coronary Intervention
A study testing musical application in people with Healthy and Nurse's Role, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy, Nurse's Role, Patient Satisfaction
- What is being tested?
- musical application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2023to 31 Dec 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being between the ages of 18-65,
- being literate,
- having no communication or hearing impairment or neurological-psychiatric disease,
- not taking sedatives before the procedure
- not having undergone PCI before
- being in the waiting room at least 20 minutes before the procedure.
Who cannot join
- Under the age of 18
- Do not speak Turkish
- Have a hearing problem
- Without a place and time orientation
- Have any psychiatric illness
- Using sedative or analgesic drugs in the last 24 hours
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- To be intervened outside the femoral area
- Previous angiography procedure
- Non-volunteer individuals will not be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Hospital
Kocaeli, Umuttepe Campus, İzmit, 41380
About this study
Official title: The Effect of Music on Healing in Patients Undergoing Percutaneous Coronary Intervention
This study was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used.
Read the detailed description
In the study, before the patients in the music group (MG) who would undergo planned CAG listened to music, while the patients were in the ward before the procedure; Patient information form, vital signs registration form, numerical rating scale, state-trait anxiety scale were applied, then 15-20 minutes. Music prepared with expert suggestions (Rast, Acemasiran, and Huseyni modes) 15-20 min. was listened to. After the procedure, patients in MG are given 15-20 minutes before being discharged. music was played. Then, the vital signs registration form, Numerical Rating Scale, state-trait anxiety scale, Perianesthesia Comfort Scale, and Patient Satisfaction Survey on Nursing Care Quality were administered for the last time. The specified survey forms were applied to the patients in Control Group before and after the procedure, and they were not allowed to listen to music.
- Conditions
- Healthy, Nurse's Role, Patient Satisfaction
- Being tested
- musical application
- Keywords
- nursing care, recovery, anxiety, pain, vital signs, confor, quality of care
- Medical subject headings
- Patient Satisfaction, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musical applicationOther
Rast, Acemasiran, and Huseyni from Classical Turkish Music modes were optionally offered to the patients in the music group, and the patient's preferred music was listened to through headphones for 15-20 minutes before the CAG procedure. Following the interviews, musical genres were arranged as instrumental, without words, at 70 decibels in terms of rhythm and duration, at approximately 60 metronomes per minute, and were played according to the person's preference. Instrumental music was loaded onto the portable MP3 player provided by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in this group received routine care and no music application was performed. |
| Experimental group | Experimental | The patient information form, vital signs registration form, and state-trait anxiety scale were administered to the patients in the music group while they were in the ward before being sent to the CAG laboratory. Afterward, Rast, Acemasiran, and Huseyni music from Classical Turkish Music modes were optionally offered to the patients, and before the CAG procedure (while the patient was waiting for the procedure in the CAG laboratory), the music preferred by the patients was played with headphones for 15-20 minutes in order not to disturb other patients. After CAG, 15 minutes after the patient arrived at the service, he listened to music for 15-20 minutes. Then, the vital signs registration form, state-trait anxiety scale, Perianesthesia Comfort Scale-PCS" and Patient Satisfaction Survey on Nursing Care Quality (PSSNCQ) were applied. Receives: Other: musical application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Means of subjective pain scores
Numerical Rating Scale was used to measure the pain intensity of the patients. This scale, which aims to determine the pain intensity of patients regarding the procedure area, aims to explain the patient's pain with numbers.It is stated that numerical scales are more widely adopted by patients because they facilitate the definition of pain intensity, facilitate scoring and recording, and are useful in floor and ceiling effect assessment. The form ranging from 0 to 10 was used in the research. In the form, 0 points are considered "no pain", 1-3 points are considered "mild pain", 4-6 points are considered "moderate pain", and 7 and above points are considered "severe pain".
Measured: before and up to 30 minutes after the coronary angiography
Means of body temperature (0C)
It will be measured by the researcher responsible for the application using an infrared thermometer.
Measured: before and up to 30 minutes after the coronary angiography
Means of systolic blood pressure (mmHg)
The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by researcher responsible for the application.
Measured: before and up to 30 minutes after the coronary angiography
Means of diastolic blood pressure (mmHg)
The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by the researcher responsible for the application.
Measured: before and up to 30 minutes after the coronary angiography
Means of heart rate (/minutes)
It will be measured by the researcher responsible for the application with a pulse oximeter in the unprocessed arm.
Measured: before and up to 30 minutes after the coronary angiography
Means of respiratory rate (/minutes)
It will be counted by the researcher responsible for the application by monitoring chest movements for one minute.
Measured: before and up to 30 minutes after the coronary angiography
Means of oxygen saturation (%)
It will be measured by the researcher responsible for the application with a pulse oximeter in the unprocessed arm.
Measured: before and up to 30 minutes after the coronary angiography
Means of subjective anxiety scores
These scales determine state and trait anxiety levels, and include two separate sections consisting of a total of 40 items developed based on the two-factor anxiety concept. The first 20 of these measure the situation-related anxiety level, and the items from 21 to 40 measure the individual's trait anxiety level. It is stated that 20-39 points obtained from the scale are considered as "mild", 40-59 points as "moderate", 60-79 points as "severe anxiety" and 80 points as "panic".
Measured: before and up to 30 minutes after the coronary angiography
Means of Perianesthesia Comfort Scale Scores
The Perianesthesia Comfort Scale scale which reveals the individual's thoughts, emotions, and self-understanding during the stages of the surgical process, consists of 24 items and the expressions are in Likert type ranging from 1 to 6 points. The highest total score that can be obtained from the scale is 144, and the lowest total score is 24. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated in the 1-6 distribution. The highest total score that can be obtained from the scale is 144, and the lowest total score is 24. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated in the 1-6 distribution. A low score indicates that comfort is bad, and a high score indicates that comfort is good.
Measured: Up to 30 minutes from coronary angiography
Means of Patient Satisfaction Survey on Nursing Care Quality Scores
Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ): This scale which comprises 19 items in total, includes 4 items that evaluate the perception of general satisfaction and are not included in the calculation. A 5-point Likert-type scale is scored between "(5) excellent" and "(1) poor". The PSNCQQ, where two different methods can score, was scored by adding the scores for all items and averaging each patient.
Measured: Up to 30 minutes from coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start7 Oct 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELDA MERT, Kirsehir Ahi Evran Universitesi
- Investigators
- Selda MERT, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293248
- Sponsor's protocol ID
- 77979112
- Status last verified
- Sep 2025
- First submitted
- 27 Feb 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research will be made available through the journal after it is published.
Publications
Mert S, Topbas O, Baydemir C, Sahin T, Ozbek H. Impact of a Structured Music Intervention on Patient Recovery and Nursing Care in Percutaneous Coronary Intervention: A Randomised Controlled Trial. J Eval Clin Pract. 2026 Feb;32(1):e70363. doi: 10.1111/jep.70363.
PubMed 41532172
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Healing in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06293248
- Acronym / sponsor ID
- 77979112
- Conditions
- Healthy, Nurse's Role, Patient Satisfaction
- Keywords
- nursing care, recovery, anxiety, pain, vital signs, confor, quality of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 7 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Mar 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 was planned to examine the effect of music application on recovery in patients undergoing coronary angiography (CAG) and to obtain the opinions of patients and nurses about music.This study was conducted to examine the effect of music application on recovery in patients undergoing CAG and to obtain the opinions of patients and nurses about music.The study was planned as a pre-test, post-test design, single-center, randomized controlled experimental study. The study is planned to be conducted in the CAG unit of a university hospital between July 2023 and December 2023, the study sample will be composed of a total of 210 individuals, 105 in each group (music applied group before and after the procedure = 105, control group = 105) To collect data in the study, the "Patient Information Form", Vital Signs Evaluation Form", "Numerical Rating Scale", State-Trait Anxiety Inventory, "Perianesthesia Comfort Scale" and "Patient Satisfaction Survey on Nursing Care Quality" were used.
Detailed description
In the study, before the patients in the music group (MG) who would undergo planned CAG listened to music, while the patients were in the ward before the procedure; Patient information form, vital signs registration form, numerical rating scale, state-trait anxiety scale were applied, then 15-20 minutes. Music prepared with expert suggestions (Rast, Acemasiran, and Huseyni modes) 15-20 min. was listened to. After the procedure, patients in MG are given 15-20 minutes before being discharged. music was played. Then, the vital signs registration form, Numerical Rating Scale, state-trait anxiety scale, Perianesthesia Comfort Scale, and Patient Satisfaction Survey on Nursing Care Quality were administered for the last time. The specified survey forms were applied to the patients in Control Group before and after the procedure, and they were not allowed to listen to music.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in this group received routine care and no music application was performed. |
| Experimental group | Experimental | Other: musical applicationThe patient information form, vital signs registration form, and state-trait anxiety scale were administered to the patients in the music group while they were in the ward before being sent to the CAG laboratory. Afterward, Rast, Acemasiran, and Huseyni music from Classical Turkish Music modes were optionally offered to the patients, and before the CAG procedure (while the patient was waiting for the procedure in the CAG laboratory), the music preferred by the patients was played with headphones for 15-20 minutes in order not to disturb other patients. After CAG, 15 minutes after the patient arrived at the service, he listened to music for 15-20 minutes. Then, the vital signs registration form, state-trait anxiety scale, Perianesthesia Comfort Scale-PCS" and Patient Satisfaction Survey on Nursing Care Quality (PSSNCQ) were applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being between the ages of 18-65,
- being literate,
- having no communication or hearing impairment or neurological-psychiatric disease,
- not taking sedatives before the procedure
- not having undergone PCI before
Key exclusion criteria (9 listed)
- Under the age of 18
- Do not speak Turkish
- Have a hearing problem
- Without a place and time orientation
- Have any psychiatric illness
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 |
|---|---|---|
| musical applicationRast, Acemasiran, and Huseyni from Classical Turkish Music modes were optionally offered to the patients in the music group, and the patient's preferred music was listened to through headphones for 15-20 minutes before the CAG procedure. Following the interviews, musical genres were arranged as instrumental, without words, at 70 decibels in terms of rhythm and duration, at approximately 60 metronomes per minute, and were played according to the person's preference. Instrumental music was loaded onto the portable MP3 player provided by the researchers. | Other | Experimental group |
Primary outcome
Means of subjective pain scores
Time frame: before and up to 30 minutes after the coronary angiography
Numerical Rating Scale was used to measure the pain intensity of the patients. This scale, which aims to determine the pain intensity of patients regarding the procedure area, aims to explain the patient's pain with numbers.It is stated that numerical scales are more widely adopted by patients because they facilitate the definition of pain intensity, facilitate scoring and recording, and are useful in floor and ceiling effect assessment. The form ranging from 0 to 10 was used in the research. In the form, 0 points are considered "no pain", 1-3 points are considered "mild pain", 4-6 points are considered "moderate pain", and 7 and above points are considered "severe pain".
Means of body temperature (0C)
Time frame: before and up to 30 minutes after the coronary angiography
It will be measured by the researcher responsible for the application using an infrared thermometer.
Means of systolic blood pressure (mmHg)
Time frame: before and up to 30 minutes after the coronary angiography
The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by researcher responsible for the application.
Means of diastolic blood pressure (mmHg)
Time frame: before and up to 30 minutes after the coronary angiography
The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by the researcher responsible for the application.
Means of heart rate (/minutes)
Time frame: before and up to 30 minutes after the coronary angiography
It will be measured by the researcher responsible for the application with a pulse oximeter in the unprocessed arm.
Means of respiratory rate (/minutes)
Time frame: before and up to 30 minutes after the coronary angiography
It will be counted by the researcher responsible for the application by monitoring chest movements for one minute.
Means of oxygen saturation (%)
Time frame: before and up to 30 minutes after the coronary angiography
It will be measured by the researcher responsible for the application with a pulse oximeter in the unprocessed arm.
Means of subjective anxiety scores
Time frame: before and up to 30 minutes after the coronary angiography
These scales determine state and trait anxiety levels, and include two separate sections consisting of a total of 40 items developed based on the two-factor anxiety concept. The first 20 of these measure the situation-related anxiety level, and the items from 21 to 40 measure the individual's trait anxiety level. It is stated that 20-39 points obtained from the scale are considered as "mild", 40-59 points as "moderate", 60-79 points as "severe anxiety" and 80 points as "panic".
Means of Perianesthesia Comfort Scale Scores
Time frame: Up to 30 minutes from coronary angiography
The Perianesthesia Comfort Scale scale which reveals the individual's thoughts, emotions, and self-understanding during the stages of the surgical process, consists of 24 items and the expressions are in Likert type ranging from 1 to 6 points. The highest total score that can be obtained from the scale is 144, and the lowest total score is 24. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated in the 1-6 distribution. The highest total score that can be obtained from the scale is 144, and the lowest total score is 24. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated in the 1-6 distribution. A low score indicates that comfort is bad, and a high score indicates that comfort is good.
Means of Patient Satisfaction Survey on Nursing Care Quality Scores
Time frame: Up to 30 minutes from coronary angiography
Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ): This scale which comprises 19 items in total, includes 4 items that evaluate the perception of general satisfaction and are not included in the calculation. A 5-point Likert-type scale is scored between "(5) excellent" and "(1) poor". The PSNCQQ, where two different methods can score, was scored by adding the scores for all items and averaging each patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Derived from this study: PubMed 41532172Mert S, Topbas O, Baydemir C, Sahin T, Ozbek H. Impact of a Structured Music Intervention on Patient Recovery and Nursing Care in Percutaneous Coronary Intervention: A Randomised Controlled Trial. J Eval Clin Pract. 2026 Feb;32(1):e70363. doi: 10.1111/jep.70363.
- Individual participant dataSharing planned: No. The research will be made available through the journal after it is published.
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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.
Selda MERT, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musical application in people with Healthy and Nurse's Role, run by Kocaeli 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 11 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Means of subjective pain scores (time frame: before and up to 30 minutes after the coronary angiography). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293248, which also lists 1 linked publication.
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 11 Sep 2025.