Patient CareNCT06670612
The Effect of Nature-Based Music Concert on Intensive Care Patients
A study testing nature based music concert in people with Patient Care and Patient Care in ICU, run by Sevcan Karataş at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study was planned to determine the effect of nature-based music recital on pain and physiological parameters in intensive care patients. Design: This research will be conducted as a pre-test post-test randomized controlled intervention study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Care, Patient Care in ICU
- What is being tested?
- nature based music concert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 10 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Having orientation to place and time
- No communication (visual, auditory) barriers
- No neuromuscular blockade with medication
- Not applying nerve block,
- Not having peripheral neuropathy or quadriplegia
- Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS)
Who cannot join
- Glasgow Coma Scale score below 13 points
- Being diagnosed with a psychiatric disease
- Having dementia/brain dysfunction
- Having a hearing-related anomaly or health problem
- The patient has not undergone any painful procedure within the last hour.
- Sedation level should be 5 and 6 according to RSQ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nature-Based Music Concert on Pain and Physiological Parameters in Intensive Care Patients
Purpose: This study was planned to determine the effect of nature-based music recital on pain and physiological parameters in intensive care patients.
Design: This research will be conducted as a pre-test post-test randomized controlled intervention study. Patient Information Form, Numerical Pain Scale and Physiological Parameters Tracking Form will be used as data collection forms.
H1: Nature-based music recital has an effect on pain level
H2: Nature-based music recital has an effect on physiological parameters
- Conditions
- Patient Care, Patient Care in ICU
- Being tested
- nature based music concert
- Keywords
- music, pain, nature based music, physiological parameter
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nature based music concertOther
Also called music concert
It will be a resource for healthcare professionals to develop a behavior that will support patients in intensive care in relieving their pain and stabilizing their physiological parameters with nature-based music, and will contribute to the literature.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | . Being 18 years or older
* Having orientation to place and time
* No communication (visual, auditory) barriers
* No neuromuscular blockade with medication
* Not applying nerve block,
* Not having peripheral neuropathy or quadriplegia
* Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS) Receives: Other: nature based music concert |
| control group | No intervention | . Being 18 years or older * Having orientation to place and time * No communication (visual, auditory) barriers * No neuromuscular blockade with medication * Not applying nerve block, * Not having peripheral neuropathy or quadriplegia * Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Scale
The numerical scale, which is the most commonly used scale in diagnosing pain, is quite simple to use. This scale has numerical values between 0 and 10 points, and the individual is shown the scale and asked to choose the number that best describes the pain. It consists of a horizontal line with a starting point of "0" or "No pain" and an end point of "10" or "Unbearable pain".
Measured: 1 hour from the music concert to the end of the application
Physiological Parameters Tracking Form
It is a form containing patients' physiological parameters. While the patients are lying down in their rooms, blood pressure will be measured from the brachial artery, and heart rate and oxygen saturation values will be measured by the researcher using bedside monitors with pulse oximeter sensors.
Measured: 1 hour from the music concert to the end of the application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start10 Apr 2024
- Primary completion10 Nov 2024 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient CareStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sevcan Karataş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevcan Karataş, İstanbul Yeni Yüzyıl Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670612
- Sponsor's protocol ID
- 2024/03-1241
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nature-Based Music Concert on Pain and Physiological Parameters in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06670612
- Acronym / sponsor ID
- 2024/03-1241
- Conditions
- Patient Care, Patient Care in ICU
- Keywords
- music, pain, nature based music, physiological parameter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Sevcan KarataşUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Nov 2024 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 1 Nov 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.
Purpose: This study was planned to determine the effect of nature-based music recital on pain and physiological parameters in intensive care patients.
Design: This research will be conducted as a pre-test post-test randomized controlled intervention study. Patient Information Form, Numerical Pain Scale and Physiological Parameters Tracking Form will be used as data collection forms.
H1: Nature-based music recital has an effect on pain level
H2: Nature-based music recital has an effect on physiological parameters
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: nature based music concert. Being 18 years or older * Having orientation to place and time * No communication (visual, auditory) barriers * No neuromuscular blockade with medication * Not applying nerve block, * Not having peripheral neuropathy or quadriplegia * Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS) |
| control group | No intervention | –. Being 18 years or older * Having orientation to place and time * No communication (visual, auditory) barriers * No neuromuscular blockade with medication * Not applying nerve block, * Not having peripheral neuropathy or quadriplegia * Sedation level 1, 2, 3 and 4 according to the Ramsey Sedation Scale (RSS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being 18 years or older
- Having orientation to place and time
- No communication (visual, auditory) barriers
- No neuromuscular blockade with medication
- Not applying nerve block,
Key exclusion criteria (6 listed)
- Glasgow Coma Scale score below 13 points
- Being diagnosed with a psychiatric disease
- Having dementia/brain dysfunction
- Having a hearing-related anomaly or health problem
- The patient has not undergone any painful procedure within the last hour.
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 |
|---|---|---|
| nature based music concertAlso: music concertIt will be a resource for healthcare professionals to develop a behavior that will support patients in intensive care in relieving their pain and stabilizing their physiological parameters with nature-based music, and will contribute to the literature. | Other | intervention group |
Primary outcome
Numerical Pain Scale
Time frame: 1 hour from the music concert to the end of the application
The numerical scale, which is the most commonly used scale in diagnosing pain, is quite simple to use. This scale has numerical values between 0 and 10 points, and the individual is shown the scale and asked to choose the number that best describes the pain. It consists of a horizontal line with a starting point of "0" or "No pain" and an end point of "10" or "Unbearable pain".
Physiological Parameters Tracking Form
Time frame: 1 hour from the music concert to the end of the application
It is a form containing patients' physiological parameters. While the patients are lying down in their rooms, blood pressure will be measured from the brachial artery, and heart rate and oxygen saturation values will be measured by the researcher using bedside monitors with pulse oximeter sensors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nature based music concert in people with Patient Care and Patient Care in ICU, run by Sevcan Karataş 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 7 inclusion and 6 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 1 Nov 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?
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?
Numerical Pain Scale (time frame: 1 hour from the music concert to the end of the application). The study lists 2 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 1 Nov 2024.