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Effect of citrus Aurantium on sleep quality in the elderly with heart failure

Protocol summary

Summary
Objectives:The aim of this study was to determine the effect of citrus Aurantium on the quality of sleep in elderly patients with heart failure.Design:this non blinding randomized clinical trial is done in the heart and CCU parts of Fatemeh Zahra Hospital in sari, Razi Hospital in Ghaemshahr,Rouhani in Babol.Study Population : Elderly patients with heart failure.Inclusion criteria: Age 60 and above, NYHA class 3 and 4,Passed at least 24 hours of admission and stabilization of clinical signs, no history of allergy to citrus Aurantium،The absence of illnesses affecting the sense of smell, the lack of use of herbal remedies affecting sleep over the past two weeks.Exclusion criteria: Signs of severe allergy to citrus Aurantium , no drug and smoking, no consumption antidepressants,sedative and antihistamines,no cooperation,Lowering the level of consciousness and cardiac arrest during the study, get out of the study environment for more than 30 minutes per night.Sample size: 80 patients are divided into two groups: control and intervention.Intervention:At first, demographic characteristics questionnaire and hospital sleep quality questionnaire were completed in both groups.128/5000 In the intervention group, two drops of essential oil of 10% citrus Aurantium, placed on a cotton ball and placed within a distance of ten centimeters from the patient's nose.The patient is taught to stay on the pillow for twenty minutes.Patients in the control group receive routine care.After three nights, after a refreshing treatment, the hospital sleep quality questionnaire is filled.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061134454N1
Registration date: 2017-06-30, 1396/04/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Ehteram Sadat Ilali
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.arab1388@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-21, 1396/04/30
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of citrus Aurantium on sleep quality in the elderly with heart failure
Public title
Sleep quality in heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age 60 and above, NYHA class 3 and 4,Passed at least 24 hours of admission and stabilization of clinical signs, no history of allergy to citrus Aurantium،The absence of illnesses affecting the sense of smell, the lack of use of herbal remedies affecting sleep over the past two weeks.Exclusion criteria: Signs of severe allergy to citrus Aurantium , no drug and smoking, no consumption antidepressants,sedative and antihistamines,no cooperation,Lowering the level of consciousness and cardiac arrest during the study, get out of the study environment for more than 30 minutes per night.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Clinical randomized blocked clinical trials

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Siences(Vice chanchellor for research),Moallem Square.
City
Sari
Postal code
4816715793
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
IR.MAZUMS.REC.96.3064

Health conditions studied

1

Description of health condition studied
Sleep Quality
ICD-10 code
G47
ICD-10 code description
Sleep Disorders

Primary outcomes

1

Description
Sleep Quality
Timepoint
Before the intervention, on the morning of the fourth day after three nights the healing aroma
Method of measurement
Hospital Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The patients of control group will receive the usual care.
Category
Other

2

Description
At the beginning of the study, questionnaires (demographic characteristics questionnaire and hospital sleep quality questionnaire) were completed in both groups.In the intervention group, two drops of 10% orange spring essential oil are placed on a cotton ball and placed within a distance of ten centimeters from the nose of the patient and the patient is trained to keep the patch on for 20 minutes.After the end of three nights, the healthcare scent is filled in with the researcher on the morning of the fourth day after waking up and announcing the readiness.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital,Sari
Full name of responsible person
Zulikha Arab Firoozjayy
Street address
Fatemeh Zahra Hospital,Military Boulvard,Municipality Square
City
Sari

2

Recruitment center
Name of recruitment center
Razi Hospital ,Ghaemshahr
Full name of responsible person
Zulikha Arab Firoozjayy
Street address
Ghaemshahr, Yousef Reza St., Razi Hospital
City
Ghaemshahr

3

Recruitment center
Name of recruitment center
Rouhani Hospital,Babol
Full name of responsible person
Zulikha Arab Firoozjayy
Street address
Babol, University Square, Ganj Afrouz Street, Rouhani Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Mazandaran University of Medical Siences
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran University of Medical Sciences(Vice chancellor for research),Moallem Square.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Mazandaran University of Medical Siences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Zulikha Arab Firoozjayy
Position
Master Student in Old age nursing
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty,Vesal street ,Sari
City
Sari
Postal code
4816715793
Phone
+98 11 3216 2792
Fax
+98 11 3336 8915
Email
z.arab1388@gmail.comzarab1388@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ehteram Sadat Ilali
Position
Assistant Professor
Other areas of specialty/work
Street address
Sari, Vesal Street, Faculty of Nursing and Midwifery
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
+98 11 3336 8915
Email
paradis2082000@yahoo.com
Web page address
www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zulikha Arab Firoozjayy
Position
MasterStudent in Old age nersing
Other areas of specialty/work
Street address
Sari, Vesal Street, Faculty of Nursing Midwifery
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
+98 11 3336 7342
Email
z.arab1388@gmail.comzarab1388@yahoo.com
Web page address
www.mazums.ac.ir

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
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