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Effect of lemon essential oil on the severity of nausea and vomiting during caesarean delivery under spinal anesthesia

Protocol summary

Study aim
To determination the effect of lemon essential oil on the severity of nausea and vomiting during caesarean delivery under spinal anesthesia
Design
This is a controlled clinical trial with parallel groups, single blind, randomized using the block randomization method.
Settings and conduct
After random assignment into two groups, the demographic questionnaire is completed. Fifteen minutes before surgery, physiological variables and nausea and vomiting are recorded. In Group A, three drops of lemon essence are applied to a 10×10 cm gauze pad and attached to the patient’s collar for 15-20 minutes of inhalation. In Group B, three drops of an odorless, color-matched liquid (water + essence color) are attached similarly. Physiological indices and nausea and vomiting intensity are recorded. This study is conducted at Hakim Hospital, Neyshabur.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18-45 years, elective surgery, no history of severe pregnancy-related nausea, complete fasting time, no use of anti-nausea medication before surgery. Exclusion Criteria: History of allergy to lemon, history of gastrointestinal diseases, need for general anesthesia, need for reoperation.
Intervention groups
In the intervention group (A), 15 minutes before surgery, three drops of lemon essence will be applied using a dropper onto a 10×10 cm gauze pad from Barij Kashan company. This pad will be attached to the patient’s collar, and the patient will be instructed to inhale normally for 15-20 minutes. In control group (B), three drops of a color-matched, odorless liquid (water + essence color) similar to the lemon essence used in Group A will be applied to a 10×10 cm gauze pad, attached to the patient’s collar, with the instruction to inhale normally for 15-20 minutes.
Main outcome variables
Severity of nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160825029520N7
Registration date: 2024-12-01, 1403/09/11
Registration timing: registered_while_recruiting

Last update: 2024-12-01, 1403/09/11
Update count: 0
Registration date
2024-12-01, 1403/09/11
Registrant information
Name
kiana babaei
Name of organization / entity
tarbiat modares university
Country
Iran (Islamic Republic of)
Phone
+98 44010724
Email address
k.babaei@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lemon essential oil on the severity of nausea and vomiting during caesarean delivery under spinal anesthesia
Public title
Effect of lemon essential oil on the severity of nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-45 years old Elective surgery Not history of severe nausea and vomiting during pregnancy Complete NPO time Not taking anti-nausea medication before surgery
Exclusion criteria:
History of allergy to lemon History of gastrointestinal diseases Need for general anesthesia Need for reoperation
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 143
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign individuals to two groups and ensure balanced group sizes, block randomization with block sizes of 4 will be used. Participants will be randomly allocated to Group A (lemon essence group) and Group B (distilled water group).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst will be blinded to the group allocations (Group A with lemon essence and Group B with distilled water).
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Neyshabur University of Medical Sciences
Street address
Pardis Neyshabour University of Medical Sciences
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Approval date
2024-10-29, 1403/08/08
Ethics committee reference number
IR.NUMS.REC.1403.048

Health conditions studied

1

Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Severity of Nausea and Vomiting
Timepoint
15 minutes before surgery/ after spinal/ before surgery/ after the umbilical cord clamp/ after surgery/ entering the recovery
Method of measurement
Bellville Nausea and Vomiting scoring scale

Secondary outcomes

1

Description
Blood pressure
Timepoint
15 minutes before surgery/ after spinal/ before surgery/ after the umbilical cord clamp/ after surgery/ entering the recovery
Method of measurement
Anesthesia monitoring

2

Description
Heart rate
Timepoint
15 minutes before surgery/ after spinal/ before surgery/ after the umbilical cord clamp/ after surgery/ entering the recovery
Method of measurement
Anesthesia monitoring

3

Description
Saturation of peripheral oxygen
Timepoint
15 minutes before surgery/ after spinal/ before surgery/ after the umbilical cord clamp/ after surgery/ entering the recovery
Method of measurement
Anesthesia monitoring

Intervention groups

1

Description
In the intervention group, 15 minutes before surgery, three drops of lemon essence (Barij Kashan) are placed on a 10×10 sterile gauze using a dropper, attached to the patient’s collar, and the patient is instructed to inhale it naturally for 15-20 minutes.
Category
Treatment - Drugs

2

Description
In the control group, three drops of a color-matched odorless liquid (water + lemon essence dye) are placed on a 10×10 sterile gauze, attached to the patient’s collar, and the patient is instructed to inhale it naturally for 15-20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hakim hospital
Full name of responsible person
Seyedeh maryam Seyedi
Street address
Bagh rud Rd, Hakim Hospital
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4263 8001
Email
hakim@nums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Ali Gholami
Street address
University of Medical Sciences, Neyshabur, Razavi Khorasan Province
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7505
Email
info@nums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Kiana Babaei
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
University of Medical Sciences, Neyshabur, Razavi Khorasan Province
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7505
Email
kianaanesthetist@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Kiana Babaei
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
University of Medical Sciences, Neyshabur, Razavi Khorasan Province
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7505
Email
kianaanesthetist@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Kiana Babaei
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
University of Medical Sciences, Neyshabur, Razavi Khorasan Province
City
Neyshabour
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7505
Email
kianaanesthetist@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Not applicable
Data Dictionary
Not applicable
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