The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
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General information
Not blinded
Single blinded
notblsingl
1
1
Due to the smell of chamomile, it was not possible to blind the researcher and participants, but the analyst has no information about the type of intervention related to each data.
Due to the smell of chamomile, it was not possible to blind the researcher and participants, but the analyst has no information about the type of intervention related to each data.
به دلیل بوی بابونه امکان کورسازی از نظر محقق و شرکت کنندگان نبود ولی آنالیزر اطلاعی در مورد نوع مداخله مرتبط به هر داده ندارد
به دلیل بوی بابونه امکان کورسازی از نظر محقق و شرکت کنندگان نبود ولی آنالیزر اطلاعی در مورد نوع مداخله مرتبط به هر داده ندارد
Sharing plan
no
undecided
noundecided
undecided
na
undecidedna
No study has been done yet
A decision will be made after the article is published.
No study has been done yetA decision will be made after the article is published.
هنوز مطالعه انجام نشده است
بعد از جاپ مقاله تصمیم گرفته می شود
هنوز مطالعه انجام نشده استبعد از جاپ مقاله تصمیم گرفته می شود
Protocol summary
Study aim
The effect of chamomile aromatherapy with and without oxygen on the severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia
Design
The study was a clinical trial with control group performed on 136 women who underwent cesarean section and randomly assigned to 3 intervention groups and one control group.
Settings and conduct
136 women undergoing cesarean section were randomly assigned to three intervention groups and one control group. The data collection tool was visual analogue scale completed by the researcher 6, 12, 18 hours after cesarean section
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of middle ear disease, no preeclampsia or eclampsia. No smoking or alcohol. No history of chamomile allergies. No history of olfactory problems. Cesarean section should be performed with spinal anesthesia
Change the anesthesia method
Exclusion criteria: Perform cesarean section other than cesarean section. Ill get ill and require more or less than the prescribed oxygen level. Patient needs intensive care
Intervention groups
.Intervention group received chamomile Essence oil with simple mask and small nebulizer, second group oxygenated with simple mask alone, third group received aromatherapy with nebulizer alone and control group received no intervention
Main outcome variables
Pain, bloating, nausea
General information
Reason for update
At the beginning of the study, changes were made in the intervention times and measurement times. These changes were recorded
Acronym
IRCT registration information
IRCT registration number:IRCT20141222020401N7
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2022-12-15, 1401/09/24
Update count:2
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Nazafarin Hosseini
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseini.nazafarin@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
2020-01-05, 1398/10/15
Actual recruitment end date
2020-03-18, 1398/12/28
Trial completion date
2020-03-19, 1398/12/29
Scientific title
The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
Public title
The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
no history of middle ear disease, preeclampsia or eclampsia, asthma and other acute and chronic diseases
No smoking or alcohol drinking
No history of allergy to chamomile
No history of olfactory problems
Cesarean section should be performed with spinal anesthesia
Exclusion criteria:
Change the anesthesia method
Other than cesarean section
The patient needs special care
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
136
Actual sample size reached:
136
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized block allocation method with standard 4-person blocks was used and the subjects were divided into 3 intervention groups and one control group, with labels A, B, C, D on four sheets and and oxygen interventions. Aromatherapy, oxygen therapy, aromatherapy and control were also written on four separate sheets, and a colleague who was unaware of this was asked to randomly remove a label for each intervention. In this way we had four random groups and four factorial twenty-four blocks. The size of each block was four and their order was different. Then the blocks were randomly assigned by placement and the patients were sorted. Each block of patients was assigned randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the smell of chamomile, it was not possible to blind the researcher and participants, but the analyst has no information about the type of intervention related to each data.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.YUMS.REC.1398.036
Health conditions studied
1
Description of health condition studied
pain, nausea and distention of women in post Cesarean section with spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
bloating
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section
Method of measurement
visual analog scale
2
Description
pain
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
Method of measurement
visual analog scale
3
Description
nausea
Timepoint
6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient
Category
Prevention
2
Description
Dual Oxygen Intervention alone, Double Intervention at the same time will receive 6 liters of oxygen per minute with simple face mask without aromatherapy chamomile
Category
Prevention
3
Description
Intervention group: Intervention third chamomile aromatherapy alone, Intervention group three will receive chamomile aromatherapy at the same time after sensitization test with oxygen nebulizer
Category
Prevention
4
Description
The control group did not receive oxygen and aromatherapy chamomile.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Yasuj Hospital
Full name of responsible person
Nazafarin Hosseini
Street address
Nursing school , Dr. Shahid Jalil street, Yasouj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
Hosseinichenar@yahoo.com
Web page address
https://fa.irct.ir/user/trial/66188
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research, Dr. Hossein Mari Oryad
Street address
Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
Oryadhsn@gmail.com
Web page address
https://fa.irct.ir/user/trial/66188
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Nazafarin Hosseini
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran