The aim of this study is to assess the effect of inhalation aromatherapy on the anxiety level,blood pressure and heart rate of patients who are candidate for colonoscopy. Design of this study is a randomized controlled clinical trial. A total of 100 patients with age of 18-65 years old ; without history of mental illnesses, asthma, olfactory dysfunction, allergy to the odor of the plants specially plants of peppremint and Lavender . Then the samples randomly were allocated in to Four groups: control group who inhaled the usual odor of the ward with Nebulizer mask; experimental group(1) who inhaled with nebulizer mask containing three drops of 100% Lavender essential oil and experimental group(2) who inhaled with nebulizer mask containing three drops of 100% peppremint essential oil and experimental group (3) who inhaled with nebulizer mask containing three drops of 100% Lavender essential oil and three drops of 100% peppremint essential oil. The interventions were performed on before of the colonoscopy . In order to data collection at first half an hour before of colonoscopy , the Spillberger questionnaire was filled out by the patients and physiologic criteria were assessed by the nurse. Again these stages were performed immediately before and after colonoscopy. In this study, primary outcome measure are anxiety and secondary outcome measures are blood pressure and pulse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015073123427N1
Registration date:2015-10-19, 1394/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-19, 1394/07/27
Registrant information
Name
Kazem Ayoubzadeh
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
kazem_ayobzadeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-02-19, 1394/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of inhalation aromatherapy on anxiety level, blood pressure and heart rate of the patients candidate for colonoscopy
Public title
Effect of inhalation aromatherapy on anxiety level, blood pressure and heart rate of the patients candidate for colonoscopy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age of 18-65 years old; without history of mental illnesses, epilepsy, asthma, thyroid, heart disease and olfactory dysfunction, allergy to the odor of plants specially plants of Peppermint and Lavender, the first experience of colonoscopy; willingness to participant in the study. Exclusion criteria: refuse to continue corporation in this study، use of Anti-anxiety drugs during the colonoscopy.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Ghafari street, Birjand University of Medical Siences
City
Birjand
Postal code
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
Ir.bums.1394.31
Health conditions studied
1
Description of health condition studied
Colorectal Disease
ICD-10 code
K00-K93
ICD-10 code description
k55-k56-k57-k58-k59-k60-k61-k62-k63-k64-k65
Primary outcomes
1
Description
anxiety
Timepoint
half an hour before of colonoscopy and before and after of colonoscopy
Method of measurement
Spillberger questionnaire
Secondary outcomes
1
Description
blood pressure
Timepoint
half an hour before of colonoscopy and before and after of colonoscopy
Method of measurement
Cardiac monitoring device
2
Description
heart rate
Timepoint
half an hour before of colonoscopy and before and after of colonoscopy
Method of measurement
Cardiac monitoring device
Intervention groups
1
Description
In the control group: Patients inhaled the usual odor of the ward with Nebulizer mask
Category
Prevention
2
Description
In the experimental group (1): At once, by using a dropper three drops of 100 % Lavender essential oil were poured on the nebulizer. Then, the patient and asked to inhald with mask nebulizer for 15 min.
Category
Prevention
3
Description
In the experimental group (2): At once, by using a dropper three drops of 100 %peppremint essential oil were poured on the nebulizer. Then, the patient and asked to inhald with mask nebulizer for 15 min.
Category
Prevention
4
Description
In the experimental group (2): At once, by using a dropper three drops of 100 %peppremint essential oil and three drops of 100 %lavender essential oil were poured on the nebulizer. Then, the patient and asked to inhald with mask nebulizer for 10 min.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
valiasr Hospital
Full name of responsible person
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Karbor Omolbanin
Street address
Ghaffari street
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Ayoubzadeh kazem
Position
Master of Sciences in nursing
Other areas of specialty/work
Street address
Street Ghaffari
City
Birjand
Postal code
Phone
+98 56 3239 5000
Fax
Email
kazem_ayobzadeh@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ayoubzadeh kazem
Position
Master of Sciences in nursing
Other areas of specialty/work
Street address
Street Ghaffari
City
Birjand
Postal code
Phone
+98 56 3239 5000
Fax
Email
kazem_ayobzadeh@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Ayoubzadeh kazem
Position
Master of Sciences in nursing
Other areas of specialty/work
Street address
Street Ghaffari
City
Birjand
Postal code
Phone
+98 56 3239 5000
Fax
Email
kazem_ayobzadeh@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)