Objectives: To investigate the effect of Rose extract on pain control after inguinal hernia surgery in Hamedan Shahid Beheshti Hospital. Design: A randomized, double blind clinical trial that the main author and patients are unaware of drugs groups. The sample size in this study was 80 people who were assigned to control and intervention groups with 40 member in each group. Setting and conduct: Patients undergoing inguinal hernia surgery who will be referred to Shahid Beheshti Hospital in Hamadan in 1396 and 1397 years. Inclusion criteria: Age 20 to 50 years; ASA; Classes 1 and 2; No history of opium and psychotropic drugs; No Long-term used anti inflammatory non-opoid; No systemic disease; Not sensitive to used drugs; Woman is not pregnant. Exclusion criteria: lack of access to the patient for measuring pain; patient's inability to determine the pain score for any reason; Morbidity sensitivity to the Rose extraction in the intervention group. Intervention: In the intervention group, 4 drops of rose extract of 4% were made by Barij Essence, 15 minutes prior to the end of inguinal hernia operation, and through the nares( 2 drops in each nostril). Patients were randomly assigned into two groups with 40 members and assigned to General Anesthesia and same Protocols. The primary outcome of this study was to investigate the score of the post operative pain and the secondary outcome including the complications of the used drugs, the hemodynamic status, and the amount of analgesics consumed by the patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703139597N3
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Seyed Mohamad Zolhavarieh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0020
Email address
sm.zolhavarieh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2018-05-15, 1397/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effect of Aromatherapy with Rose extract in controlling postoperative pain in inguinal hernia operation
Public title
Effect of Aromatherapy with Rose extract in controlling postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a)Age of 20-50 years; (b) Patients with class 1 or 2 according to the American Society of Anesthesiology scoring criteria; (c) No history of opium and psychotropic drugs; (d) No Long-term used anti inflammatory non-opoid; (e)No systemic disease; (f)Not sensitive to used drugs ; (g)Woman is not pregnant.
Exclusion criteria: (a) Lack of access to the patient for measuring pain; (b)the patient's inability to determine the pain score for any reason; (c) Morbidity sensitivity to the Rose extraction in the intervention group.
Age
From 20 years old to 50 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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using random block in two intervention and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
ice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.UMSHA.REC.1396.418
Health conditions studied
1
Description of health condition studied
Pain localized to other parts of lower abdomen
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
2
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Pain score
Timepoint
1, 6, 12, , and 24 hours after surgery
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
1
Description
side effects of drugs
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
questionnaire
2
Description
Hemodynamic status
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Esphigmomanometery and pulse oximetry
3
Description
Analgesic dosage used
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
In the intervention group, 4 drops of rose extract of 4% were made by Barij Essence, 15 minutes prior to the end of inguinal hernia operation, and through the nares ( 2 drops in each nostril).
Category
Treatment - Other
2
Description
In the control group, 4 drops of distilled water, 15 minutes prior to the end of inguinal hernia operation, and through the nares ( 2 drops in each nostril).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Seyed Mohammad Zolhavarieh
Street address
Shahid Beheshti Hospital, Eram Blv.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of 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
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Board of Anesthesiology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital Eram Blv.
City
Hamadan
Postal code
Phone
+98 81 3838 0749
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Board of Anesthesiology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital Eram Blv.
City
Hamadan
Postal code
Phone
+98 81 3838 0749
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Mohammad Zolhavarieh
Position
Board of Anesthesiology
Other areas of specialty/work
Street address
Hamadan
City
Hamadan
Postal code
Phone
+98 81 3838 0749
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)