To determine the effect of aromatherapy with aromatic geranium (geranium) on the anxiety and labor pain of primiparous women
Design
The clinical trial has a control group, double-blind, randomized, on 100 patients, and SPSS 22 statistical software will be used for data analysis.
Settings and conduct
Place of execution: Imam Jafar Sadiq (AS) maternity hospital, Aligudarz city, Lorestan province. Aromatherapy starts from the dilation of 4-5 cm and the intensity of pain and anxiety are measured and recorded before and 20 minutes after aromatherapy; Then the aromatherapy is repeated every 20 minutes until the end of delivery. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm. In this study, neither the researcher responsible for data entry into the software and data analysis, nor the researcher (using a nose clip during the intervention) will be aware of the allocation of patients to the experimental or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Iranian race and first birth; singleton pregnancy with an age of 37 to 42 weeks; Mother's age is 18-35 years; Dilatation 4-5 cm at the time of entering labor. Exclusion criteria: fetal distress or labor progress disorder; existence of medical and obstetrical problems in the current pregnancy; Incidence of sensitivity to geranium essential oil in a person during study; use of pain reliever or anti-anxiety medication at least 3 hours before the intervention
Intervention groups
In the aromatherapy group, 2 drops of geranium essential oil soaked in gas, and in the control group, 2 drops of distilled water soaked in gas are attached to the collar of the samples and the administration will be repeated every 20 minutes.
Main outcome variables
Labor pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091021002618N3
Registration date:2023-10-14, 1402/07/22
Registration timing:registered_while_recruiting
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Soheila Pirdadeh Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1322 9095
Email address
s.pirdadeh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-05-04, 1403/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Aromatherapy with Geranium Essence on Anxiety and Labor pain in Nulliparous Women
Public title
Evaluation of the effect of Aromatherapy with Geranium on Anxiety and Labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race and being a firstborn
Single pregnancy with age 37 to 42 weeks
Mother's age is 18-35 years
Dilatation 4-5 cm at the beginning of labor
Having at least 2-3 spontaneous uterine contractions lasting 40-45 seconds within 10 minutes
The regularity of the fetal heartbeat with a number of 110-160 beats per minute
The mother's vital signs are normal
The number of fetal movements is normal according to the mother's report
Body mass index 20-30 kg/m2
Height more than 145 cm
The estimated weight of the fetus is 2500-4000 grams
The fit of the fetal head with the mother's pelvis based on clinical examination
Proportion of uterine height with gestational age in clinical examination
Exclusion criteria:
Fetal distress or disruption of labor progress
Existence of medical and midwifery problems in the current pregnancy
Incidence of sensitivity to geranium essential oil in a person during the study
The presence of olfactory disorders, allergies or previous unpleasant experiences with certain scents
The use of painkillers or anti-anxiety drugs at least 3 hours before the intervention
Addiction to tobacco, drugs and alcohol and the need to receive them
The existence of any obstacle to perform natural childbirth
The need to strengthen labor with oxytocin or other methods
The need for an emergency caesarean section
The need to use other medicinal and non-medicinal pain reduction methods
Facing an important and unfortunate incident during the last week
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is accessible and based on the study entry criteria. In this way, after obtaining written consent from the samples, people are assigned to 2 intervention and control groups using block random allocation method and blocks of 4. By using this method, it can be ensured that an equal number of participants enter the intervention and control groups in consecutive time intervals. Entry of people into each of the groups is done according to the number of selected blocks and the arrangement inside the block. In order to prevent the possibility of the effect of the aroma spread in the air on the people of the studied groups, the department manager will be requested to place the studied samples in a separate room based on randomization and the same type of intervention received.
For blocks of 4, six modes are considered as follows, and the said blocks will be used approximately 4 times (24 people are allocated each time) so that the final sample size is allocated to two treatment and intervention groups:
1. TTCC
2. TCTC
3. TCCT
4. CCTT
5. CTCT
6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
This research will be double-blind in such a way that neither the researcher responsible for data entry into the software and data analysis nor the researcher (using a nose clip during the intervention) will be aware of the allocation of patients to the experimental or control group; Also, due to the possibility of the release of essential oil molecules in the environment, the release of pleasant odors (scented sprays) and sometimes the windows being open, we place the patients in separate LDR rooms and avoid opening the windows during the intervention; We also ask the hospital services to postpone the cleaning of the room, which is done using detergent solutions and may have an unpleasant smell, to before or after the intervention. The data will be collected by the researcher and the research assistant.
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
Headquarters of Lorestan University of Medical Sciences, Anoushirvan Rezaei Square, Moalem St.
City
Khorram abad
Province
Lorestan
Postal code
8197978133
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.LUMS.REC.1402.110
Health conditions studied
1
Description of health condition studied
Anxiety and labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety intensity score in Spielberger Anxiety Questionnaire
Timepoint
The intensity of anxiety will be measured before aromatherapy and in dilations of 4 to 5 and 8 to 10 cm.
Method of measurement
Spielberger anxiety questionnaire
2
Description
Labor pain intensity score on visual analog grade scale
Timepoint
Pain intensity will be measured before aromatherapy and at 4 to 5, 6 to 7 and 8 to 10 cm dilatations.
Method of measurement
Visual analog degree scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the aromatherapy group, 2 drops (0.13 cc) of geranium essential oil are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm.
Category
Treatment - Drugs
2
Description
Control group: In the control group, 2 drops (0.13 cc) of distilled water are soaked in gauze and attached to the collar of the samples, and the administration will be repeated every 20 minutes. The intensity of anxiety will be measured in dilatations of 4 to 5 and 8 to 10 cm and the intensity of pain in dilatations of 4 to 5, 6 to 7 and 8 to 10 cm.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam jafar sadegh hospital
Full name of responsible person
Hanieh Hafizi
Street address
Imam Jafar Sadiq (AS) Hospital, Razi Square, East Modares Street, East Boulevard
City
Aligoodarz
Province
Lorestan
Postal code
6861886486
Phone
+98 66 4332 3092
Email
h.emamjafar@lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Bahram Rasoulian
Street address
University blvd
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Fax
Email
pr.lums@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Pirdade Biranvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
kimia_n72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Pirdade Biranvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
kimia_n72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Soheila Pirdade Biranvand
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 2033
Email
kimia_n72@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