Protocol summary

Study aim
This study aimed to determine the effect (impact) of pleasant sound stimuli on hemodynamic parameters, restlessness and level of alertness in comatose patients hospitalized in Intensive Care Units in educational hospitals of Kermanshah.
Design
This interventional study is a one-blind randomized clinical trial. Based on the criteria for entering the study, 80 samples were selected purposefully and with a probability of dropping out and then randomly assigned to the intervention and control groups using packets in the package of patients.
Settings and conduct
This study was performed on chest patients admitted to intensive care units of educational hospitals in Kermanshah. this interventional study is a randomized, one-blind clinical trial .patients' packets will be assigned to two groups of intervention and control. the intervention was performed by the first collaborator and due to the insertion of headphones in the two groups, the second researcher would be unaware of the separation of the groups.
Participants/Inclusion and exclusion criteria
Entrance criteria: Alert level less than 8 years- Non use of antidepressants and stimulants- Anti-inflammatory drugs and- No previous brain damage- Lack of Exit of cerebrospinal fluid or blood from the ear and nose- Failure of fracture, bleeding and temporal and temporal regional surgery- Absence of fracture in four limbs or quadriplegia- No severe changes in intracranial pressure. Exit criteria: Discharge or death of the patient before 6 day- Dislav the patient from continuing the study- Severe changes in vital signs- Severe changes in mental status- Interruption of brain stem reflex during research.
Intervention groups
The method of intervention in the intervention group will be that a detailed account of the psychological field and the individual's interest in the particular voice will be taken. According to the description of the patient's companions, the type of intervention includes music with or without words, the voice of the Holy Quran, Tavashish, the voice of a person of interest from the family members of the patient and etc will be specified. Daily intervention in the shift in the evening hours of 17-15 is due to a lack of disturbing sensory stimuli for 10 minutes. The actions taken in the control group will be such that, after obtaining written consent from the patient's guardian for participation in the study as a control group, there will be only a non-acoustic headphone during the study for the patient. At the same time as the intervention group, hemodynamic indices and restlessness were recorded immediately and 10 minutes later during the study.
Main outcome variables
Hemodynamic parameters include heart rate, respiratory rate, systolic and diastolic blood pressures, mean blood pressure, pulse pressure, arterial oxygen saturation, and Richmond Agitation-Sedation Scale Questionnaire for measuring restlessness and using Glasgow criteria for measuring the level of consciousness of the samples Before and immediately and 10 minutes after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171024036979N1
Registration date: 2017-12-08, 1396/09/17
Registration timing: prospective

Last update: 2017-12-08, 1396/09/17
Update count: 0
Registration date
2017-12-08, 1396/09/17
Registrant information
Name
Farzad Rahimi
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 0092
Email address
f.rahimi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kurdistan University of Medical Sciences
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pleasant sound stimulation on hemodynamic parameters, the agitation and level of Consciousness in comatose patient in Intensive Care Units
Public title
The effect of pleasant sound stimulation on hemodynamic parameters, the agitation and level of Consciousness in comatose patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Alertness level equal to and less than 8 according to Glasgow Patients aged 15-75 years 24Hours after vital signs are sustained in the intensive care unit Not taking antidepressants or affecting restlessness and tranquilizers and Opiums Absence of mental disorders No previous brain damage No impairment or hearing loss Lack of cerebrospinal fluid or blood from the ears and nose Non-fracture, bleeding and temporal and temporal area surgery No addiction Not getting cancer Lack of fracture in four limbs or quadriplegic No significant changes in intracranial pressure
Exclusion criteria:
Discharge or death of the patient before day 6 Cancellation of the patient's continuation of the study Severe changes in vital signs Severe changes in mental status Severe changes in intracranial pressure Destruction of brain stem reflex during research
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for 2 randomized intervention and control groups will be assigned randomly, using packets in envelopes, envelopes 1 for intervention and 2 for control.
Blinding (investigator's opinion)
Single blinded
Blinding description
To blind the study, the first research assistant intervened and due to wearing headphones in the two groups the second researcher would not be able to differentiate between the intervention group and control group. After wearing headphones, regardless of the type of group, he will collect the information.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.MUK.REC.1396/176

Health conditions studied

1

Description of health condition studied
Coma
ICD-10 code
R40.2
ICD-10 code description
Unconsciousness NOS

Primary outcomes

1

Description
Hemodynamic parameters
Timepoint
Before, immediately and ten minutes after the intervention
Method of measurement
Systole and diastolic blood pressure with mercuric pressure gauge, moderate blood pressure with the corresponding formula, pulse pressure by decreasing systole pressure from diastol, oxygen saturation with plusoxymmeters

2

Description
Agitation
Timepoint
Before, immediately and ten minutes after the intervention
Method of measurement
Using Richmond Agitation-Sedation Scale (RASS)

3

Description
level of consciousness
Timepoint
Before, immediately and ten minutes after the intervention
Method of measurement
Using the Glasgow coma scale (GCS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, headphones are worn by patients (with playing no sound) without any other stimuli for 10 minutes for a week.
Category
Other

2

Description
Intervention group: In this group, sound stimuli pleasant for patients are played for 10 minutes for one week with headphones without any other stimuli.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Jamal Seidi
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3182 7280
Fax
+98 87 3366 0092
Email
jamal.seidi@muk.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Student Research Committee, Vice Chancellor for research and technology of Kurdistan University of M
Full name of responsible person
Farzin Rezaee
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3182 7464
Fax
+98 87 3366 0092
Email
jamal.seidi@muk.ac.ir
Grant name
بودجه عمومی
Grant code / Reference number
304
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student Research Committee, Vice Chancellor for research and technology of Kurdistan University of M
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
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Full name of responsible person
Farzad Rahimi
Position
Master of Nursing / Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
ُSanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3366 0092
Fax
+98 87 3366 0092
Email
F.Rahimi@muk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Ph.D/Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3182 7464
Fax
+98 87 3366 0092
Email
Jamal.seidi@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Ph.D/Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 873182746
Fax
+98 87 3366 0092
Email
jamal.seidi@muk.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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