The Effect of Nature-Based Music Concert on Intensive Care Patients

October 31, 2024 updated by: Sevcan Karataş

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Yeni Yuzyil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group

. 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)
Other: nature based 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.
Other Names:
  • music concert
No Intervention: control group

. 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
1 hour from the music concert to the end of the application
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.
1 hour from the music concert to the end of the application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sevcan Karataş

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

November 10, 2024

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

October 30, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Estimated)

November 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 1, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/03-1241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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