IRCT | The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients.

Protocol summary

Study aim: Determine the effect of auditory stimuli (preferred music and familiar sounds) on vital symptoms (pulse rate, blood pressure, mean arterial blood pressure, temperature) blood cortisol hormone level, level of consciousness, intracranial pressure in intensive care unit patients Shahid Rajaee Hospital of Shiraz.
Design: A randomized controlled clinical trial with parallel groups, single blind
Settings and conduct: The study was performed at Shahid Rajaee Hospital in Shiraz twice daily between 7 am and 6 pm, For two weeks with blinded data collection, the researcher used the hands free for patients during 30 minutes.
Participants/Inclusion and exclusion criteria: Inclusion criteria; Aged over 17 and under 60, Informed consent of the patient's family, GCS of 3 to 8, vital signs stable, presence of ICP transducer in patient's head, 4 hour after receiving narcotic Exclusion criteria; History of cardiovascular disease , Hypertension, Infection, Epilepsy, Prior Stroke or concussion history, Endocrine disorder, Cushing, Diabetes, Liver Failure, Kidney Failure, Brain Tumor, Alcoholism, Syncope, Hearing loss,, Major Fractures such as Limbs, Abdomen, Chest, Injury to the patient's ears by accident, Patient's family dissatisfaction at each stage of intervention, Narcotic Addiction, otorrhea, Severe smokers,Taking drugs that lead to anesthesia, taking corticosteroids, Drug and food poisoning Concurrent with a severe head injury, Blindness, bilateral eyelid inflammation or ptosis
Intervention groups: control group, patients receive routine care, Preferred Music Group:Patient Preferred Music Band based on the patient's family history, they receive music of their interest and familiar group: the patient receives the voice of the most intimate member of his or her family or friends.
Main outcome variables: Vital symptoms, intracranial pressure, blood cortisol level, level of consciousness

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20191230045944N1

Registration date: 2020-03-26, 1399/01/07

Registration timing: retrospective

Last update: 2020-03-26, 1399/01/07

Update count: 0
Registration date: 2020-03-26, 1399/01/07

Registrant information: Name

parvin delavari

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 71 3234 6313

Email address

parvin.delavari@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2013-09-23, 1392/07/01
Expected recruitment end date: 2014-04-21, 1393/02/01
Actual recruitment start date: 2013-09-23, 1392/07/01
Actual recruitment end date: 2014-09-23, 1393/07/01
Trial completion date: 2014-10-07, 1393/07/15

Scientific title: The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients.

Public title: The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

People between 18 and 60 years Informed consent of the patient's family, Glasgow coma score between 3 and 8, Vital signs are constant, Intracranial pressure transducer in patient's head, It's been 4 hours since the last time a patient was given a painkiller,

Exclusion criteria:

History of cardiovascular disease Hypertension, Infection, Epilepsy, Prior Stroke or concussion history, Endocrine disorder, Cushing, Diabetes, Liver Failure, Kidney Failure, Brain Tumor, Alcoholism, Syncope, Hearing loss, Major Fractures such as Limbs, Abdomen, Chest, Injury to the patient's ears by accident, Patient's family dissatisfaction at each stage of intervention, Narcotic Addiction, otorrhea, Severe smokers, Taking drugs that lead to anesthesia, taking corticosteroids, Drug and food poisoning Concurrent with a severe head injury, Blindness, bilateral eyelid inflammation or ptosis
Age: From 18 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Outcome assessor

Sample size

Target sample size: 54

Actual sample size reached: 54

Randomization (investigator's opinion)

Randomized

Randomization description

Fifty-four patients were divided into three groups of 18 (control, preference music, and familiar voice) using simple randomization via dice throwing. Dice numbers 1 and 2 were used for the control group, 3 and 4 for the familiar group, and 5 and 6 for the preferred music group. The throw of the dice continued until the end of the sampling. For whatever reason, if the patient were removed from any group, the dice would be thrown again. And by inserting headphones and MP3 for the patient by the researcher, blinding the outcome collector was done.

Blinding (investigator's opinion)

Single blinded

Blinding description

The data collector was not aware of the type of groups, and the accuracy of the MPTRIs and Freemasons geometry was verified by the researcher.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Kerman Medical Sciences

Street address

Kerman, Beginning of the Axis of the Seven Gardens of Alavi, Campus of the University of Medical Sciences

City

kerman

Province

Kerman

Postal code

7616913555
Approval date: 2019-12-25, 1398/10/04
Ethics committee reference number: 10/40/3815

Health conditions studied

1

Description of health condition studied: Patients with severe head injury
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: The level of blood cortisol levels
Timepoint: The first morning before and after the intervention.
Method of measurement: Due to the patient's rights and the high cost of this trial, it was measured twice in only one intervention.Blood sampling was performed by the same collector of outcomes in the Same way. The blood samples were immediately sent to the laboratory of Shahid Rajaee Hospital in Shiraz and put in a centrifuge. The centrifuge was set for five minutes and thirty rounds. After centrifuging the samples, the serum was removed by blood sampling. Serum samples were kept at -20 ° C until the end of the study. At the end of sampling, patients' serum samples were transferred to another laboratory due to lack of laboratory facilities at Shahid Rajaee Hospital in Shiraz. And all patient serum samples in a laboratory were measured by one person using a device with identical kits.

2

Description: The level of intracranial pressure
Timepoint: Before, during, and after the intervention twice daily for three days
Method of measurement: An S1800-ER monitoring device was used to measure intracerebroventricular pressure in patients with severe head trauma admitted to critical care units. It has TFT color display.Patient-related parameters were measured momentarily and updated. Intracerebral pressure was measured using a ventriculostomy implanted by a neurosurgeon within the patient's brain ventricle. Which, due to its aggressive procedure, was used only in patients who, according to their own medical needs, were diagnosed by a neurosurgeon in order to monitor intraocular pressure,The other end of the ventriculostomy was connected to the monitoring device by a transducer

3

Description: The level of consciousness
Timepoint: Before, during, and after the intervention twice daily for twelve days
Method of measurement: Using the Glasgow Coma Scale, the level of consciousness of patients with severe head injury was measured.

4

Description: blood pressure
Timepoint: Before, during, and after the intervention twice daily for twelve days
Method of measurement: Monitoring model S1800-ER was used to measure blood pressure in patients with severe head injury admitted to intensive care units.

5

Description: heart rate
Timepoint: Before, during, and after the intervention twice daily for twelve days
Method of measurement: The S1800-ER monitoring device was used to measure heart rate in patients with severe head injury admitted to intensive care units.

6

Description: Temperatures
Timepoint: Before, during, and after the intervention twice daily for twelve days
Method of measurement: The S1800-ER monitoring device was used to measure the armpit temperature of patients with severe head injury in intensive care units.

7

Description: Mean arterial pressure
Timepoint: Before, during, and after the intervention twice daily for twelve days
Method of measurement: The S1800-ER monitoring device was used to measure mean arterial pressure in patients with severe head injury admitted in intensive care units.

8

Description: Cerebral perfusion pressure
Timepoint: Before, during, and after the intervention twice daily for three days.
Method of measurement: We reduced the mean arterial pressure from intracranial pressure.

Secondary outcomes

1

Description: Level of consciousness, intracranial pressure level, blood cortisol level, vital signs
Timepoint: Before, during and after the intervention twice daily for two weeks
Method of measurement: Using the Glasgow Coma Scale, intracranial blood pressure transducer, cardiovascular monitoring device, blood sampling and sending to the laboratory

Intervention groups

1

Description: First intervention group: Familiar voices were heard for thirty minutes. Which, based on the patient's family history, recorded the most intimate voice of the patient in a quiet environment. And there was no whimper or cryingwhen recording the sound.While talking to the patient several times, they called the patient by the name they were calling home and in their intimate surroundings. And the person who was recording his voice introduced himself to the patient in his own cultural language at the beginning of the recording. She told the patient what had happened to her and was admitted to the intensive care unit. And he assured the patient to keep track of his treatment and return to health. And they talked about what was going on in the last month and what they were going to do after the patient recovered.
Category: N/A

2

Description: Control group: These patients were receiving routine care in the intensive care unit, and no other new work was being done in the twelve days they were monitored. The headphone was used for thirty minutes for this group of patients who did not make any noise to ensure that the outcome collector was not aware of the control group.
Category: N/A

3

Description: Preferred Music group:The patient's favorite music sound was played for thirty minutes based on the patient's family history of using the headphones.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Shahid Rajaee Hospital of Shiraz

Full name of responsible person

Parvin Delavari

Street address

No. 46 3rd Floor, 46 Nikan Street,

City

Shiraz

Province

Fars

Postal code

7133613546

Phone

+98 71 3234 6313

Fax

+98 71 3647 4590

Email

parvin.delavari@yahoo.com

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Unes Ghasemy

Street address

No. 46 3rd Floor, 46 Nikan Street,

City

Shiraz

Province

Fars

Postal code

7313613546

Phone

+98 71 3234 6313

Fax

+98 71 3647 4590

Email

parvin.delavari@yahoo.com

Web page address

http://research.sums.ac.ir/fa/index.html#
Grant name: It is done at a personal cost
Grant code / Reference number: 0
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Persons

Person responsible for general inquiries

Contact: Name of organization / entity

Bam University of Medical Sciences

Full name of responsible person

abas abaszadeh

Position

University President

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Bam - Martyr Sardar Square - Shahid Rajaei Boulevard

City

Bam

Province

Kerman

Postal code

7616913555

Phone

+98 34 4434 1120

Fax

+98 34 4434 0847

Email

aabaszadeh@hotmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

parvin delavari

Position

PhD Student of Nursing in Semnan University of Medical Sciences.

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

46 Nikan Street, No. 46 3rd Floor

City

Shiraz

Province

Fars

Postal code

00987133613546

Phone

00982346313

Fax

+98 71 3647 4590

Email

parvin.delavari@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

parvin delavari

Position

PhD student in Nursing

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

No. 46 3rd Floor, 46 Nikan Street,

City

Shiraz

Province

Fars

Postal code

7133613546

Phone

+98 71 3234 6313

Fax

+98 71 3647 4590

Email

parvin.delavari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available
Title and more details about the data/document: Information about the main outcome can be shared
When the data will become available and for how long: Access started 6 months after printing.
To whom data/document is available: All interested people in academic, scientific and industrial institutions have permission to use.
Under which criteria data/document could be used: Systematic review and ongoing research in this field
From where data/document is obtainable: parvin delavari; parvin.delavari@yahoo.com
What processes are involved for a request to access data/document: Apply via e-mail
Comments

The effect of hearing stimuli (familiar sounds and preferred music) on intracranial blood pressure level, level of consciousness, cortisol level and vital signs of severe head injury patients.