Comparison of the Effect of Nature Sound and Family Voice on Physiological Indicators and Level of Consciousness (LOC) of Patients Admitted to Intensive Care Units (ICU)
Comparison of the Effect of Nature Sound and Family Voice on Physiological Indicators and Level of Consciousness (LOC) of Patients Admitted to Intensive Care Units (ICU)
Design
Randomized controlled clinical trial
Determining the exact sample size using a statistical formula with a 95% confidence level and a 5% error
Sampling by Easy Access Method
Randomly in 3 groups
Settings and conduct
Shahid Rajaei Hospital and Razi Social Security Hospital in Qazvin
Participants/Inclusion and exclusion criteria
Age group 15-60 years
Of both sexes
5< Glasgow Coma Scale Score <8
The Patient's Guardian should read and sign the Informed Consent
Intervention groups
Intervention Group 1: In addition to routine care, play a set of nature sounds (night, wind, rain, sea, waterfall, birds, river and crickets) with an intensity of 60 to 70 decibels for 5 days, twice a day in the morning shift and Evening for 30 minutes with MP3 player and ambient soundproof headphones
The second group of intervention: playing a tape of the patient's favorite person in the family for 10 minutes with the content (informing the patient of the person, time and place, brief description of what happened to the patient, expressing sweet memories of the past and phrases From the recovery of the patient and his return to the family) by MP3 Player
Control group: Receiving routine ward care for all patients admitted to intensive care units
Main outcome variables
Auditory stimulation
Level of consciousness
Age
Gender
marital status
Education level
Underlying diseases
Cause of coma
Duration of coma
Mechanical ventilation
Drugs
Systolic blood pressure
Diastolic blood pressure
Number of breaths
Pulse count
Tympanic temperature
Arterial blood oxygen saturation SPO2
Family member ratio
Average arterial blood pressure
MAP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201016049038N1
Registration date:2020-12-08, 1399/09/18
Registration timing:prospective
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Reyhaneh Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 6412
Email address
r.rahmani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Nature Sound and Family Voice on Physiological Indicators and Level of Consciousness (LOC) of Patients Admitted to Intensive Care Units (ICU)
Public title
Effect of Nature Sound on Physiological Indicators and Level of Consciousness (LOC) Effect of Family Voice on Physiological Indicators and Level of Consciousness (LOC)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 15 and 60 years old
Both sexes
5<Glassco Coma Score<8
Hospitalization in the intensive care unit
Exclusion criteria:
Unknown Patients
Having a history of brain injury
Hearing imparment or loss
Fractures of the skull in the temporo mandibular area and bleeding
Having diabets
Heart and fat diseases
History of addiction
Fractures in the four limbs
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
No. 37, Sanaye Dasti Alley., Mulla Sadra Street
City
QAZVIN
Province
Qazvin
Postal code
3418854134
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.QUMS.REC.1399.297
Health conditions studied
1
Description of health condition studied
Patients with Brain Injury Coma Patients
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
The level of consciousness of stroke patients
Timepoint
Before, during and 2 minutes after each auditory stimulation
Method of measurement
Glasgow Coma Scale score (GCS)
Secondary outcomes
1
Description
Physiological indicators of stroke patients
Timepoint
Before and during and two minutes after the intervention
Method of measurement
Devices for control of blood pressure, respiratory rate view, touch the heart rate, pulse oximetry and mercury thermometer
Intervention groups
1
Description
Intervention group: In addition to routine care, the group broadcasts a collection of nature sounds (night, wind, rain, sea, waterfall, birds, river and crickets) with an intensity of 60 to 70 decibels for 3 days, twice a day in the morning and evening shifts for 30 minutes with MP3 player and soundproof headphones Interference
Category
Treatment - Devices
2
Description
Intervention group: The second group of intervention: playing a tape of the patient's favorite person in the family for 10 minutes with the content (informing the patient of the person, time and place, brief description of what happened to the patient, expressing sweet memories of the past and phrases From the recovery of the patient and his return to the family) by MP3 Player
Category
Treatment - Devices
3
Description
Control group: Control group: receiving routine care in the intensive care unit
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajai Hospital
Full name of responsible person
Leyli Yekke Fallah
Street address
Shahid Safdari Alley, Padegan Street
City
QAZVIN
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
rehi_rahmani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr leyli yekke fallah
Street address
22 Bahman Boulevard
City
Qazvin
Province
Qazvin
Postal code
3418854134
Phone
+98 28 3366 4001
Email
rehi_rahmani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reyhane Rahmani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Babaei Street., Razi Hospital
City
Qazvin
Province
Qazvin
Postal code
3418854134
Phone
+98 28 3386 0179
Email
rehi_rahmani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reyhaneh Rahmani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 14, West KHAKALI 29., Noruziyan Town
City
Ghazvin
Province
Qazvin
Postal code
3418854134
Phone
+98 28 3366 6412
Email
rehi_rahmani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reyhane Rahmani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 14, West 29., Parastar Blvd., Noruziyan Town
City
Ghazvin
Province
Qazvin
Postal code
3418854134
Phone
+98 28 3366 6412
Email
rehi_rahmani@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data used in the research can be shared after the intervening people have not been identified and after the end of the study. Including participants, data, data analysis, attachments, informed consent and other documents
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Everyone
Under which criteria data/document could be used
If the researcher is a member of the medical staff or a student, the use of documents is unrestricted and all analyzes will be provided to them for use in their research.
From where data/document is obtainable
Refer to me Reyhaneh Rahmani, the author and executor of the project, through the following communication channels:
Email address: rehi_rahmani@yahoo.com
Phone number: 09128403680
What processes are involved for a request to access data/document
Finally, over the next year and fall, 1,400 documents or data files can reach applicants.