The Effect of Nature-Based Music Concert on Intensive Care Patients
1 other identifier
interventional
108
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2024
CompletedFirst Submitted
Initial submission to the registry
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2025
CompletedNovember 1, 2024
October 1, 2024
7 months
October 30, 2024
October 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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".
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.
1 hour from the music concert to the end of the application
Study Arms (2)
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)
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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sevcan Karataşlead
Study Sites (1)
Istanbul Yeni Yuzyil University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
October 30, 2024
First Posted
November 1, 2024
Study Start
April 10, 2024
Primary Completion
November 10, 2024
Study Completion
April 10, 2025
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share