1. Home
  2. Approved trials
  3. » فارسی

Comparison between the effect of music therapy and aromatherapy in sleep quality and physiological indices in myocardial infarection patients

Protocol summary

Summary
This study is a randomized clinical trial to determine the effect of aromatherapy (lavender) and music therapy (Music sounds of nature) On physiological parameters (pulse rate and respiration, blood pressure, body temperature, the blood, peripheral arterial oxyhemoglobin Sachvryshn) and sleep quality in patients with myocardial infarction , This study randomly samples three groups (music, Aromatherapy and control) in blocks of six with a sample size of 129 will perform, After obtaining informed consent from patients and if there is inclusion criteria (absence of any known allergies, lack of smell or hearing disorders, etc.) will be done for three consecutive nights, Physiological indicators in all three groups before and after an hour of sleep and six oclock in morning wii be measuurd and sleep quality questionnaire twice, once before the start of the study and a second time after completion of the study are evaluated The band an hour before the usual patients sleep through the hands of Sony music players for 30 to 45 minutes . And for aromatherapy, aromatherapy with essential oils of Lavender of an hour before six in the morning will wake up, The control group will not be any interference from the researcher, all data will be collected and analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122019919N8
Registration date: 2016-09-10, 1395/06/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-10, 1395/06/20
Registrant information
Name
Arefeh Davoodi Bavil Oliaii
Name of organization / entity
Nursing and Midwifery of Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0648
Email address
adavoodi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Tabriz University of Medical Sciences
Expected recruitment start date
2016-03-29, 1395/01/10
Expected recruitment end date
2016-08-31, 1395/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of music therapy and aromatherapy in sleep quality and physiological indices in myocardial infarection patients
Public title
Comparison between the effect of music therapy and aromatherapy in sleep quality and physiological indices in myocardial infarection patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Would like to participate in the study and signed an informed consent form؛ male and female patients aged 30 to 75 years who are hospitalized in the intensive care unit with a diagnosis of myocardial infarction؛ complete consciousness and awareness of time, place or person؛ Auditory and olfactory disorder, according to the patient and not be a member of the immediate family؛ History of eczema, hives or respiratory problems such as allergies to flowers and plants and not name؛ Any serious mental disorder, according to the patient or is not a member of the immediate family؛ scores from the initial assessment questionnaire Pittsburgh Sleep Quality Index is equal to or less than 5. Exclusion criteria: Avoid proceeding at any stage of intervention؛ drug addiction (according to the patient or a family member)؛ employment health
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz medical sciences
Street address
tabriz university of scinces - university street -= univrsity gate- tabriz
City
Tabriz
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
TBZMED.REC.1395.3

Health conditions studied

1

Description of health condition studied
myocard infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
improve the quality of life and mean arterial presure
Timepoint
Sleep quality: on the first evening and the morning were the fourth day Inclusion
Method of measurement
Pittsburgh Sleep Quality Index

2

Description
mean arterial presure
Timepoint
One hour before and one hour after 6 am after the intervention and intervention for three consecutive nights
Method of measurement
Using calibrated monitoring devices available in the cardiac care unit

Secondary outcomes

1

Description
Improve the physiological (arterial systolic and diastolic blood pressure), body temperature, arterial oxyhemoglobin saturation, heart rate and respiration disease
Timepoint
One hour before and one hour after the experimental intervention and at 6 am after a period of three consecutive nights
Method of measurement
Using standard monitoring devices available in the tympanic thermometer devices

Intervention groups

1

Description
In the music therapy in patients for three consecutive nights, music of your choice that evening, the first day of the intervention of the music list which is approved by the Ministry of Islamic GuidanceThe hearing through headphones, choose and one hour before sleep for 30 to 45 minutes via the hands-free type Sony will hear in your bed And physiological index patients one hour before and one hour after 6 am after music therapy and the use of monitoring devices measuring and marking Alborz 7b in the chart will be provided in the table, the process is carried out for three consecutive nights will be The patient's sleep quality using the Pittsburgh Sleep Quality Index intervention once before and again after the third night will be completed by the patients.
Category
Prevention

2

Description
In the control group with no intervention will be done by the researcher, only routine interventions and treatments that can be performed for all patients receive.
Category
N/A

3

Description
Patients in the aromatherapy group for three consecutive nights, each night an hour before sleep four drops of essential oil on a cotton ball spilled pure lavender After two minutes inhaling from a distance of two inches of the pin nose up at 6 am to Dickey install and notes of treated patients, cotton balls at six of Dickey patients will be isolated.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
The Cardiac Care Unit 1 at Shahid Madani Hospital
Full name of responsible person
Afkham Vargaeei
Street address
Madani Martyr Hospital - University Street - University
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences (Primary Sponsor)
Full name of responsible person
Dr.Rashidi Mohammad Reza
Street address
University Street- University
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences (Primary Sponsor)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical scinces - School of Nursing and Midwifery
Full name of responsible person
Suri Jafarlu Vahid
Position
MSc student -Expert
Other areas of specialty/work
Street address
Tabriz- South Shariati Street - School of Sursing and Midwifery
City
Tabriz
Postal code
56941-68451
Phone
+98 452721690
Fax
-
Email
sori1991vahid@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Scinces - School of Nursing and Midwifery
Full name of responsible person
Arefe Davoodi
Position
Instructor- Msc
Other areas of specialty/work
Street address
South Shariati Street -School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 34770648
Fax
Email
arefehdavoodi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery-Tabriz University of Medical Sinces
Full name of responsible person
Suri Jafarlu Vahid
Position
MSc Student-Expert
Other areas of specialty/work
Street address
Scool of Nursing and Midwifery-Shariati Square Tabriz
City
Tabriz
Postal code
Phone
+98 452721690
Fax
Email
sori1991vahid@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...