NCT06670612

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 30, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

musicpainnature based musicphysiological parameter

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)

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)

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.

Also known as: music concert
intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Istanbul Yeni Yuzyil University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations