The effect of aroma therapy versus placebo on the pain and anxiety due to sternotomy in patients after open heart surgery: a double blinded randomized controlled trial
Objectives: To assess the effect of aroma therapy on the pain and anxiety due to sternotomy in patients after open heart surgery.
Design: A double blinded randomized controlled trial.
Setting and conduct: The patients underwent open heart surgery with GCS equal to 15 will be enrolled into the study.
Participants including major eligibility criteria: The patients with any one of the following characteristics will be excluded from the study; (a) having pulmonary problems; (b) narcotic and alcohol addiction or drug abuse; (c) scent impairment; (d) history of convulsion; (e) using anti-anxiety drugs; (f) intubation for more than 24 hours.
Intervention: Pouring two drops of 2% lavender oil produced by Barij Esans Company into the oxygen mask and patients began inhale through the mask for 20 minutes in the second and third days after surgery.
Control: Pouring two drops of distilled water into the oxygen mask and patients began inhale through the mask for 20 minutes in the second and third days after surgery.
Primary outcome measures: Relief of pain after surgery using ruler scaled from zero to ten.
Secondary outcome measures: Assessment of anxiety using Spielberg questionnaire, and stress and depression using DASS 21 questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203299014N9
Registration date:2012-07-02, 1391/04/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-02, 1391/04/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aroma therapy versus placebo on the pain and anxiety due to sternotomy in patients after open heart surgery: a double blinded randomized controlled trial
Public title
The effect of aroma therapy versus placebo on the pain and anxiety due to sternotomy in patients after open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
The patients underwent open heart surgery with GCS equal to 15 will be enrolled into the study. The patients with any one of the following characteristics will be excluded from the study; (a) having pulmonary problems; (b) narcotic and alcohol addiction or drug abuse; (c) scent impairment; (d) history of convulsion; (e) using anti-anxiety drugs; (f) intubation for more than 24 hours.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Human Subject Review board
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
D/P/16/35/9/1116
Health conditions studied
1
Description of health condition studied
Chest pain post sternotomy after open heart surgery
ICD-10 code
I97
ICD-10 code description
Postprocedural disorders of circulatory system, not elsewhere classified
Primary outcomes
1
Description
Relief of pain due to sternotomy post open heart surgery
Timepoint
24 hours
Method of measurement
Ruler scaled from zero to ten
Secondary outcomes
empty
Intervention groups
1
Description
Pouring two drops of 2% lavender oil produced by Barij Esans Company into the oxygen mask and patients began inhale through the mask for 20 minutes in the second and third days after surgery.
Category
Treatment - Drugs
2
Description
Pouring two drops of distilled water into the oxygen mask and patients began inhale through the mask for 20 minutes in the second and third days after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Dr Ali Beikmoradi
Street address
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Ahmad tavilani
Street address
Financial support from one percent budget specified to research projects
City
Hamadan
Grant name
از محل يك درصد بودجه طرحهاي تحقيقاتي دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Hamadan 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
Research Center for Health Sciences, Department of Epidemiology & Biostatistics
Full name of responsible person
Dr Jalal Poorolajal
Position
MD, PhD, Assistant Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
+98 81 1838 0090
Fax
+98 81 1838 0509
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Internal Medicine and Surgery
Full name of responsible person
Dr Ali Beikmoradi
Position
PhD
Other areas of specialty/work
Street address
Department of Internal Medicine and Surgery, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
6517838695
Phone
Fax
Email
bikmoradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)