Protocol summary

Study aim
Determining the effect of aromatherapy with clove essential oil on anxiety and pain after caesarean section in women admitted to Taleghani Hospital, Ilam.
Design
Clinical trial with control group, without blinding, randomized on 72 patients
Settings and conduct
In this randomized clinical trial, the number of 72 women who have Inclusion criteria are divided into two intervention and control groups. Inclusion criteria include: age 18-49 years, spontaneous pregnancy, low-risk pregnancy, olfactory health, women under spinal anesthesia, live birth with Apgar 7 and above, elective cesarean section (of predetermined), less than 3 pregnancies, less than 3 deliveries, gestational age between 37-42 weeks. Exclusion criteria include: allergy to cloves, feeling uncomfortable with the smell of essential oil during the study, possible annoying side effects, history of respiratory problems and migraines, emergency caesarean section, general anesthesia, any type of medical problem, history of mental disorders before and during pregnancy, history of previous surgery on the uterus, The duration of cesarean section is extended to more than one hour. 3 hours after leaving the operating room, related questionnaires will be completed and pain and anxiety scores will be measured. Then the intervention will be done at 4, 8 and 12 hours after cesarean section by inhaling 3 drops of clove essential oil on a cotton swab at a distance of ten centimeters from the nose for 10 minutes. Half an hour after each intervention, the level of pain and anxiety will be measured.
Participants/Inclusion and exclusion criteria
The research community of this study will be women aged 18-49 who undergo cesarean surgery in Taleghani Hospital in Ilam city in 1402
Intervention groups
Aromatherapy group with clove scent Aromatherapy group with normal saline
Main outcome variables
Pain, Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101218005415N3
Registration date: 2024-01-03, 1402/10/13
Registration timing: registered_while_recruiting

Last update: 2024-01-03, 1402/10/13
Update count: 0
Registration date
2024-01-03, 1402/10/13
Registrant information
Name
fatemeh janani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3312 0140
Email address
janani.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-31, 1402/10/10
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aromatherapy with clove essential oil on anxiety and Post cesarean section pain
Public title
Investigating the effect of aromatherapy with clove essential oil on anxiety and Post cesarean section pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a volunteer to participate in the study Age 18-49 years Spontaneous pregnancy Low risk pregnancy Olfactory health women under spinal anesthesia live birth with Apgar 7 and above Elective cesarean section (predetermined) Frequency of pregnancy less than 4 Birth frequency less than 3 Gestational age 37 to 42 weeks
Exclusion criteria:
Reluctance to participate in the study Allergy to cloves History of respiratory problems and migraines History of mental disorders (depression) before and during pregnancy History of liver and kidney problems (essential oils are excreted through liver, kidney and exhalation) History of previous surgery on the uterus (other than caesarean section) Suffering from high blood pressure Suffering from migraines Suffering from autoimmune and inflammatory diseases Performing other surgery with caesarean section
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples into groups is done using Block Randomization method. In order to equalize the history of previous cesarean section and the level of anxiety before the intervention in the study groups, first there are classes as having a history of cesarean section / no history of cesarean section and low (20-30) / moderate (31-42) / severe (<43) anxiety, (6 classes) create and then the co-epidemiologist of the project determines the allocation of people to the study groups using the blockrand R software package and makes it available to the research team so that the people are placed in the groups based on the order of entry and belonging to each class be studied in a balanced way.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the data analyst will not know the type of intervention for the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of lorestan university of medical Sciences
Street address
Kamalvand road
City
Khoram Abad
Province
Lorestan
Postal code
6814993165
Approval date
2023-12-09, 1402/09/18
Ethics committee reference number
IR.LUMS.REC.1402.292

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

2

Description of health condition studied
Anxiety
ICD-10 code
F48
ICD-10 code description
Other nonpsychotic mental disorders

Primary outcomes

1

Description
Pain, Anxiety
Timepoint
4,8,12 hours after cesarean
Method of measurement
Visual Analogue Scale, Spielberger questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Aromatherapy group with clove essential oil
Category
Treatment - Other

2

Description
Control group: Aromatherapy group with normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Kimiya Radmanesh
Street address
Shahid Beheshti Blvd, Ilam town, Iran
City
Ilam
Province
Ilam
Postal code
6931817671
Phone
+98 939 341 7677
Email
kimiyaradmanesh2014@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fateme janani
Street address
Kamalvand road, Khoram Abad town, Iran
City
Khoram Abad
Province
Lorestan
Postal code
-
Phone
+98 66 3330 0661
Fax
+98 66 3330 0661
Email
janani.f@lums.ac.ir
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fateme Janani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand road
City
Khoram Abad
Province
Lorestan
Postal code
6814993165
Phone
+63 3300661
Email
janani.f@lums.ac.ir
Web page address
http://www.lums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fateme Janani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand Road, Lorestan University of Medical Sciences
City
Khoram Abad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3330 0661
Email
janani.f@lums.ac.ir
Web page address
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi48KTqooqDAxV4gP0HHdG4CdIQFnoECAYQAQ&url=http%3A%2F%2Fwww.lums.ac.ir%2F&usg=AOvVaw2QTns_Bhs54kRbrgyqFni9&opi=89978449

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Fateme Janani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand road, Khoram Abad town, Iran
City
Khoram Abad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3330 0661
Email
janani.f@lums.ac.ir
Web page address
http://www.lums.ac.ir/

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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