Musical Intervention on Stress Effects in Critically Ill Patients

Sponsor

University of Oviedo (Other)

Overall Status

Recruiting

CT.gov ID

NCT06120660

Collaborator

Sociedad Española de Enfermería Intensiva y Unidades Coronarias (Other)

200

Enrollment

Location

Arms

26.6

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.

Condition or Disease	Intervention/Treatment	Phase
Critical Care Respiration, Artificial Sedation	Other: Music Therapy	N/A

Detailed Description

Design, Setting and Study Subjects: A randomized clinical trial will be conducted in the ICU of a spanish tertiary hospital. The study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention.

Variables: The main variable will be total serum cortisol, prolactin, interleukin-6 levels. Secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention.

Data collection: There will be 2 groups: intervention and control. The sample will be randomized as patients are admitted. First, they will be receiving the corresponding daily care. The first group of patients will receive the corresponding daily care. The patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. All the variables will be collected before starting the study, during the study and at the end of the study.

Data analysis: A descriptive analysis of each variable will be performed. Subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. If statistically significant, post-hoc tests will be performed using Dunn's test.Dunn's test. Statistical significance will be accepted when p ≤ 0.05.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Musical Intervention on Stress Effects in Critically Ill Patients

Actual Study Start Date :

Oct 14, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Case Group Music	Other: Music Therapy Music Therapy
No Intervention: Control Group

Arm

Intervention/Treatment

Experimental: Case Group

Music

Other: Music Therapy

Music Therapy

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

levels of serum cortisol [Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.]
µg/dL
levels of prolactin [Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.]
ng/mL
levels of interleukin 6 [Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.]
pg/mL

Secondary Outcome Measures

Bispectral Index (BIS) [Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.]
From 0 to 100
Blood Pressure [Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.]
mmHg
Heart rate [Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.]
bpm
Respiratory rate [Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.]
breaths per minute
Oxygen Saturation [Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults
Admitted to the ICU for a minimum of 24 hours
Intubated patients undergoing invasive mechanical ventilation
Arterial catheter carriers / central venous catheter
Sedation level: BIS: 40 - 60
No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale
Not having previously undergone any other musical intervention.

Exclusion Criteria:

Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.)
Severe psychiatric illness
Suspected or confirmed drug or alcohol overdose/intoxication/abstinence
Hearing impairment
Skull lesions that preclude the use of headphones
Patients with limitation of therapeutic effort or death expected within 24 hours
Brain death diagnosis
Failure to obtain informed consent from the legal representative within 72 hours of presentation
Refusal of the responsible physician.