This study is conducted for evaluating the effects of pleasing olfactory images on the atelectasis in Patients with cardiac surgery in Fatemeh Zahra hospital in Sari. This is a clinical trial in which 80 patients who are candidate for open heart surgery using sternotomy and cardiopulmonary bypass support, randomly allocated to groups of experiment and control. Patients having no: neuromuscular and cognitive disorders; respiratory failure; hemodynamic instability; ejection fraction less than 30 percent; mental retardation; olfactory impairment; preoperative pulmonary disease(pneumonia, chronic obstructive pulmonary disease, atelectasis, pleural effusion and asthma); BMI more than 40 kg/m2; positive history of previous heart or lung surgery; positive history of previous severe trauma to the head or nose and positive history of previous frequent sinus infections will be studied. Patients who are allocated in experiment group will receive planned training before surgery. Designed cards with pictures of rose, banana, apple and lemon placed at their disposal and Will be asked to look at these pictures and Imagine the smell of it in their minds and as much as possible to do deep sniffing. The exercises will be conducted for two hours in the morning and evening during the first and second day after surgery at the awakening. Patients who are allocated in control group will receive the hospital routine treatment. For comparing the outcomes ABG, atelectasis in chest x ray will be compared. Arterial blood gasses will be compared pre operation and first and second day post operation. Chest x ray will be compared pre operation and second day post operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503157494N11
Registration date:2015-04-25, 1394/02/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of pleasing olfactory images on the atelectasis in patients with cardiac surgery
Public title
The effects of pleasing olfactory images on the atelectasis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in the study؛ no emergency surgery(coronary artery bypass and heart valves using sternotomy and cardiopulmonary bypass support)؛ aged 18 years and older؛ ejection fraction more than 30 percent؛ having no mental retardation and olfactory impairment؛ negative history of previous heart or lung surgery؛ negative history of previous severe trauma to the head or nose؛ negative history of previous frequent sinus infections؛ Lack of preoperative pulmonary disease(pneumonia, chronic obstructive pulmonary disease, atelectasis, pleural effusion and asthma)؛ BMI less than 40 kg/m2. Patients with systolic blood pressure less than 90 mm Hg despite additional fluids؛ PH arterial less than 7.30؛ arterial carbon dioxide pressure greater than 50 mmHg؛ arterial oxygen saturation less than 80% despite oxygen؛ blood hemoglobin concentration of less than 7 g/dL؛ serum creatinine greater than3.5 mg/dL were not included in the study.
Exclusion criteria: patients' unwillingness to continue cooperation؛ need for reoperation due to surgery complications؛ incidence of cognitive and neurological disorders after surgery؛ postoperative hemodynamic instability(systolic blood pressure below 80 mm Hg)؛ postoperative bleeding more than 500 ml؛ need for mechanical ventilation for more than 15 hours after surgery.
Age
From 18 years old
Gender
Both
Phase
2
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran.
City
Sari
Postal code
4816715793
Approval date
2016-03-03, 1394/12/13
Ethics committee reference number
13/12/1393
Health conditions studied
1
Description of health condition studied
Atelectasis
ICD-10 code
J98.1
ICD-10 code description
Pulmonary collapse
Primary outcomes
1
Description
Atelectasis
Timepoint
Pre & post operation and second day post operatively
Method of measurement
Chest x ray
Secondary outcomes
1
Description
Arterial blood gases
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Arterial blood gas test(ABG)
2
Description
Systolic and diastolic arterial blood pressure
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Sphygmomanometer
3
Description
Tempereture
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Oral Thermometer
4
Description
Respiratory rate
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Number of respiratory rate
5
Description
Heart rate
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Cardiac monitoring
6
Description
Saturation of Peripheral Oxygen
Timepoint
Before surgery; the morning and afternoon of the first day of surgery, before and after the intervention; morning and afternoon of the second day after surgery, before and after the intervention
Method of measurement
Monitor and pulse oximetry
Intervention groups
1
Description
Patients who are allocated in
experiment group will receive
planned trainings before surgery.
Designed cards with pictures of
rose, banana, apple and lemon
placed at their disposal and Will
be asked to look at these
pictures and Imagine the smell
of it in their minds and as much
as possible to do deep sniffing.
The exercises will be conducted
for two hours in the morning
and evening during the first and
second day after surgery at the
awakening
Category
Prevention
2
Description
Patients who are allocated in
control group will receive the
hospital routine treatment. Any
intervention is not done before
surgery for this group of
patients.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra hospital
Full name of responsible person
Dr Masoumeh Bagheri- Nesami
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr Ahmad Ali Enayeti
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street, Moalem Square, Sari, Iran.
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 Sciences.
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
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three-way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran.
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Masumeh Bagheri Nesami
Position
PHD/ faculty member
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, three way Joibar, highway Basij, Imam square, Sari, Mazandaran, Iran.
City
Sari
Postal code
4816715793
Phone
+98 11 3336 7551
Fax
Email
anna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)