A single blind randomized, controlled trial will be conducted to determine the effects of Cardamoms inhalation aromatherapy on the mothers' nausea and vomiting in peri & post-operation of the elective Cesarean section. 70 eligible mothers will be randomly allocated to the placebo group (n=35) or experimental group (n=35). Inclusion criteria: Having 16-48 years old; Literacy; Singleton and normal infants; Elective operation through Spinal anesthesia; Nausea after starting spinal anesthesia.
Exclusion criterion: both mother and fetus poor conditions.
All eligible subjects will be trained about the three deep breathes of bags (inhalation for 3 seconds and exhalation for 7 seconds) and evaluating their nausea severity on VAS(0-100 mm). The two 2"× 2" gas-Pad will be moistened with 2 ml of distilled water without (Placebo group) or with 2 drops of essential oil of cardamom (Experimental group) put in the zipper plastic bags. During surgery, after mother's nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers in the experimental group will be asked to breathe deeply three times of the oil of cardamom soaked pads and the mothers in the placebo group will be asked to breathe deeply three times of the distilled water soaked pads. Again, two minutes later, the same breathing patterns will be repeated in both groups. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050333794N1
Registration date:2017-06-05, 1396/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-05, 1396/03/15
Registrant information
Name
Masumeh Mirzaiee
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3333 0425
Email address
mas.mirzaee@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Cardamoms Inhalation Aromatherapy on the Mothers' Nausea and Vomiting in Peri & Post-Operation of the Elective Cesarean Section
Public title
Cardamom aromatherapy on the women's nausea and vomiting in Cesarean Section operation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mothers with16-48 years old; Literacy; Singleton and normal infants; Elective Cesarean section operation through Spinal anesthesia; Nausea after starting spinal anesthesia; Lack of nausea due to the underlying disease (Gastrointestinal and kidney diseases) or during the third trimester of pregnancy; A healthy olfactory sense; No history of asthma and respiratory distress due to cardiopulmonary diseases; No allergies to herbal essences and Cardamom; No taking antiemetic or emetic medications or herbal medications during past twenty-four hours; and no opioid addiction and tobacco using.
Exclusion criterion: Mothers with an inappropriate process of caesarean section operation (both mother and fetus poor conditions); More than twice spinal needle insertions or use of general anesthesia follow it; An inability to determine the severity of nausea according to VAS despite training; Vomiting or retching during the research intervention.
Age
From 16 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.UMSHA.REC.1396.91
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O82.9
ICD-10 code description
O82.9 Delivery by caesarean section, unspecified
Primary outcomes
1
Description
The severity of nausea of mothers' peri- & post-operation of the Cesarean Section
Timepoint
Before the intervention (initial measurement), 5 minutes after intervention, Post-Operation: in the recovery room and 2 hours after operation
Method of measurement
Visual Analogue Scale (VAS 0-100)
Secondary outcomes
1
Description
Frequency of vomiting
Timepoint
during surgery, in the recovery room and 2 hours after operation
Method of measurement
Frequency
2
Description
Frequency of retching
Timepoint
during surgery, in the recovery room and 2 hours after operation
Method of measurement
Frequency
Intervention groups
1
Description
The two 2 "× 2" gas-Pad will be moistened with 2 ml of distilled water put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the distilled water soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.
Category
Placebo
2
Description
The two 2 "× 2" gas-Pad will be moistened with 2 ml of of distilled water with 2 drops of essential oil of cardamom put in the zipper plastic bags in a separate room every day. During surgery after mother's expressing nausea, the onset nausea severity based on the VAS will be recorded. Then, the mothers will be asked to breathe deeply three times of the oil of cardamom soaked pads. Again, two minutes later, the same breathing patterns will be repeated. The severity of subjects' nausea based on the VAS will be measured and recorded after five minutes. The frequency of their retching and vomiting during surgery, recovery and two hours after the operation will be assessed in both groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr hospital Malayer
Full name of responsible person
Akbar Fazeli
Street address
Malayer, Iran nabovat
City
Malayer
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
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 for Research and Technology of 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, Nursing & Midwifery School, Medical-Surgical Nursing Depart
Full name of responsible person
Zahra Khalili
Position
Master of Science, Faculty Member
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard
City
Hamadan
Postal code
8698365178
Phone
+98 81 1838 0319
Fax
+98 81 1838 0447
Email
zkhalili90@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mother and Child Care Research Center, Hamedan University of Medical Sciences, Nursing & Midwifery S
Full name of responsible person
Dr. Mahnaz Khatiban
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard
City
Hamadan
Postal code
8698365178
Phone
+98 81 3838 0535
Fax
+98 81 3838 0447
Email
m-khatiban@umsha.ac.ir; mahnaz.khatiban@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
Masumeh Mirzaee
Position
Candidate of Master of Sciences in Medical Surgical Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard
City
Hamadan
Postal code
8698365178
Phone
+98 81 3333 0425
Fax
+98 81 3335 1047
Email
mas.mirzaee@edu.umsha.ac.ir؛nmirzaiy75@gmail .com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)