Comparison of the effect of aromatherapy with lavender and cloves on headache severity caused by spinal anesthesia in patients undergoing urological surgery in Bahonar Hospital in Kerman in 2021-2022
Comparison of the effect of aromatherapy with cloves and lavender on pain caused by spinal anesthesia in patients undergoing urological surgery in Bahonar Hospital in Kerman in 2021-2022
Design
Patients who meet the inclusion criteria were selected by available sampling method and randomly divided into three groups: aromatherapy with lavender, aromatherapy with cloves and control.
Settings and conduct
The research environment will be Shahid Bahonar Hospital. First, the demographic and background information questionnaire is completed using the file and, if necessary, the patient for each sample. After transferring the patient to recovery, pain intensity is measured and recorded in each group based on visual scale. Then, the members of the intervention group undergo aromatherapy. There is no intervention in the control group and they receive routine care as usual.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 to 60 years, no previous history of spinal anesthesia, No sensitivity to aromatic substances, No history of infection Respiratory diseases such as asthma, sinus disorders and rhinitis and not using aromatherapy for the patient for a week before the intervention
Exclusion criteria: re-spinal anesthesia and the emergence of skin and respiratory allergies in the patient
Intervention groups
Intervention group: A sterile gas with 3 drops of fragrance (lavender and cloves) is impregnated with 5% concentration and placed at a distance of 10 cm from the patient's nose and the patient inhales it for 5 minutes and this again 8 Repeat 24 hours later.
Control group: In patients in the control group, inhalation of gas impregnated with normal saline is performed and 8 and 24 hours after surgery for the desired variable.
Main outcome variables
Headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211124053172N1
Registration date:2022-01-01, 1400/10/11
Registration timing:registered_while_recruiting
Last update:2022-01-01, 1400/10/11
Update count:0
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Atena Samareh Fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 3491
Email address
atena.samarehfekri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aromatherapy with lavender and cloves on headache severity caused by spinal anesthesia in patients undergoing urological surgery in Bahonar Hospital in Kerman in 2021-2022
Public title
The effect of aromatherapy with lavender and cloves on headache severity caused by spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No previous history of spinal anesthesia
Classes 1 and 2 based on ASA classification
Lack of blindness and deafness due to the use of visual pain scale
No history of migraine and chronic headache
Lack of sensitivity to aromatic substances
No history of respiratory disease such as asthma, sinus disorders and rhinitis
Do not use aromatherapy for the patient for a week before the intervention
No mental health problems with a doctor's diagnosis
Perform anesthesia by an anesthesiologist with a needle of the same size with just one attempt
No coagulation disorders
Exclusion criteria:
Perform re-spinal anesthesia
Induction of general anesthesia
Having an absolute rest of more than 8 hours
Emergence of skin and respiratory allergies in the patient
Preoperative headache
pregnant women
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were selected by convenience sampling method and randomly divided into three groups: aromatherapy with lavender, aromatherapy with cloves and control. To compile a random list, the online software https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used, the size of the blocks will be 6 and the two variables of gender (male / female) and age ( Less than 30 years old) will be considered as classes when creating a random list.
Blinding (investigator's opinion)
Single blinded
Blinding description
At the beginning of the intervention, patients in the intervention group separately in the recovery so that other patients are not exposed to inhalation of the drug by one of the operating room staff who is not present in the study, A sterile gas with 3 drops of fragrance with the desired concentration of 5% (lavender or clove) is impregnated and placed at a distance of 10 cm from the patient's nose and the patient inhales it for 5 minutes This is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department.In patients in the control group, inhalation of gas impregnated with normal saline is performed and 8 and 24 hours after surgery are examined for the desired variable. In the control group, no intervention is performed.And receive routine care as usual. In addition, all medications received by patients in a total of 24 hours after surgery are recorded in all three intervention and control groups.Also, the environmental conditions, including closing the doors and windows, minimizing the pleasant and unpleasant odors in the ward, are equalized for the three groups. Also, the two intervention groups were placed in separate rooms.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
campus of Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2021-11-08, 1400/08/17
Ethics committee reference number
IR.KMU.REC.1400.495
Health conditions studied
1
Description of health condition studied
patients undergoing urological surgery
ICD-10 code
ICD-10 code description
urological surgery
Primary outcomes
1
Description
Pain score on the VAS scale
Timepoint
Pain measurement at the beginning of the study (before the intervention) and 30 minutes after the second intervention (8 hours after surgery) and the third (24 hours after surgery)
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of lavender with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department.
Category
Prevention
2
Description
Intervention group 2: At the beginning of the intervention, patients in the intervention group separately in recovery so that other patients are not exposed to inhalation of the drug, a sterile gas with 3 drops of cloves with a concentration of 5% impregnated and placed 10 cm from the patient's nose It is taken and the patient inhales it for 5 minutes, and this is repeated 8 hours and 24 hours later, and 30 minutes after the second and third interventions, the amount of pain is measured and recorded. The second intervention (8 hours after the operation) and the third (24 hours after the operation) are performed there due to the transfer of the patient to the urology department.
Category
Prevention
3
Description
Control group: There is no intervention in the control group and they receive routine care as usual.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital, Kerman
Full name of responsible person
Atena Samarehfekri
Street address
Gharani Street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
atena.samarehfekri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samarehfekri
Street address
campus of Kerman University of Medical Sciences, The beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
atena.samarehfekri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
University employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 22 , Blv jomhouri 13
City
Kerman
Province
Kerman
Postal code
00000000000
Phone
+98 34 3211 3491
Fax
Email
atena.samarehfekri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
University employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 22 , Blv jomhouri 13
City
Kerman
Province
Kerman
Postal code
00000000000
Phone
+98 34 3211 3491
Fax
Email
atena.samarehfekri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
University employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 22 , Blv jomhouri 13
City
Kerman
Province
Kerman
Postal code
00000000000
Phone
+98 34 3211 3491
Fax
Email
atena.samarehfekri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available