Protocol summary

Study aim
Comparison of the effect of auriculotherapy and aromatherapy with Citrus aurantium on the labor pain intensity and some variables of maternal and neonatal outcomes
Design
Sampling method: available Randomization with permuted blocks will be used to allocate the samples to three groups. 138 samples will be placed in 23 blocks of 6 and the random allocation list will be done by Random Allocation software. The sample size was determined with G*Power software with a power of 80% and α = 0.05 (type 1 error) and using the same information of previous article (effect size 0.625). Finally, 46 samples will be determined in each group, taking into account the 10% attrition.
Settings and conduct
Sampling will be done by the available method in the active phase of labor and in the labor department by dividing the participants into three groups: auriculotherapy, aromatherapy and control. The outcome assessor and the participants will be blinded due to not knowing which group the participants will be in.
Participants/Inclusion and exclusion criteria
Iranian primiparous women aged 18 to 35 who had an uncomplicated pregnancy
Intervention groups
In the aromatherapy group, gauze impregnated with Citrus aurantium will be attached to their collars, and seedless adhesives are attached to four points of ears. In the auriculotherapy group, adhesives with Vacaria seeds are attached to the primary and essential points of two ears. Also, gauze soaked in distilled water will be attached to their collar . In the control group, seedless adhesives will be applied to four unrelated points in both ears. In addition, gauze soaked with distilled water will be attached to their collars. Meanwhile, all three groups will receive the usual maternity care.
Main outcome variables
labor pain intensity, anxiety intensity, length of the active phase, length of the second stage, Apgar

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231212060342N1
Registration date: 2023-12-29, 1402/10/08
Registration timing: prospective

Last update: 2023-12-29, 1402/10/08
Update count: 0
Registration date
2023-12-29, 1402/10/08
Registrant information
Name
Fatane Eeftekhari Shah Abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3821 3003
Email address
eftekhary.fatane@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-30, 1402/10/09
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative the effect of auriculotherapy and aromatherapy with Citrus aurantium aroma on intensity of labour pain and some variables of maternal and neonatal outcomes in primiparous women: A Double Blinded Randomized Controlled Trial
Public title
Comparative the effect of auriculotherapy and aromatherapy with Citrus aurantium aroma on intensity of labour pain and some variables of maternal and neonatal outcomes in primiparous women: A Double Blinded Randomized Controlled Trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian women Prim parous women Having minimum literacy that is able to read and write Term pregnancy Singleton pregnancy with an alive fetus A fetus with cephalic presentation A fetus with an approximate weight of less than 4 kg Start of spontaneous labor contractions 4 cm dilation of the cervix A pelvis with suitable dimeters for childbirth Intact amniotic membranes Written Informed consent to participate in this study Bilateral external ear without any lesion (mass, swelling, infection or wound) for doing auriculotherapy
Exclusion criteria:
Use of painkillers in the last eight hours Using any complementary or traditional medicines to start labor pain Diagnosed liver, gall bladder or respiratory diseases Chronic diabetes or gestational diabetes Olfactory disorders in the aromatherapy group Allergy to herbal medicines for the aromatherapy group Allergy to Citrus aurantium in the aromatherapy group Pregnancy complications (such as pre-eclampsia, chorioamnionitis, placental abruption and abnormal fetal heart rate, etc.)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, permutation block method will be used to allocate samples to three groups (no intervention - auriculotherapy group - aromatherapy group) , 138 samples will be placed in 23 blocks of 6. Random allocation list is provided by Random software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the aromatherapy group, gauze impregnated with 4 drops of citrus aurantium aroma (Adonis Gol Daru Company-Iran) will be attached to the neck of the participants. gauzes will be changed every 30 minutes until the cervix has reached 10 centimeters dilation. In addition, in order to avoid bias, for all participants in the aromatherapy group, grain-free adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then every 30 minutes in between uterus contraction, a gentle palpation is placed on one of the ears by the project manager, but these points will not be pressed. In the auriculotherapy group, pressure on the main points of the ear in the external ear (point zero, shen men, sympathetic, thalamus) with the aim of reducing pain and anxiety and the primary points of the ear (uterus (C), uterus (E), Gonadotrophins, ovaries, pelvis , abdomen) with the aim of reducing pain and helping the progress of labor, is applied by a trained researcher who has completed the preliminary auriculotherapy course in 22 hours under the supervision of the Iranian Midwifery Association. To avoid creating bias, auriculotherapy is performed by one person for all research subjects. First, the right ear is cleaned using alcohol, pressure is applied using adhesives containing vacaria seeds for auriculotherapy by ZhongyanTaihe Company, which is available in the Iran, for 30 seconds between contractions, and finger pressure is applied on the vacaria seeds. After 30 minutes, the same points in the left ear are pressed for 30 seconds between contractions, and with finger pressure on the Vacaria seeds. The seeds are compressed alternately on the right and left ear every 30 minutes and each time for 30 seconds until the time of dilation of 10 cm. Finger pressure on the seeds to the extent that the pain is tolerable for the samples. In order to avoid bias, in the auriculotherapy group, a moisten gauze with 4 drops of distilled water will be attached to the collar of all participants. gauzes will be changed every 30 minutes until 10 cm dilation For all participants in the control group, seedless adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then, every 30 minutes, a gentle hand is placed on one of their ears, but these points will not be pressed. In addition, for all participants in this group, gauze soaked with 4 drops of distilled water will be attached to their collars. Gauzes will be changed every 30 minutes until 10 cm dilation. Also, all three groups will receive the usual maternity care. For blinding, the outcome evaluator and the participants will not be informed of which group each sample belongs to, and only the project manager who performs the necessary interventions in the labor and delivery room will know about the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s
Street address
Faculty of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۱۳۱۱۹
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.105

Health conditions studied

1

Description of health condition studied
Labor pain intensity
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified

2

Description of health condition studied
Labor anxiety
ICD-10 code
O94-O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified

3

Description of health condition studied
Active phase length of delivery
ICD-10 code
O80-O84
ICD-10 code description
Delivery

Primary outcomes

1

Description
Labor pain intensity
Timepoint
The intensity of labor pain in all three groups will be measured at 4 cm dilatation (before the start of the intervention) and 20 minutes after the start of the intervention at 4 cm dilation as well as at 6 and 8 cm.
Method of measurement
To determine the intensity of labor pain, the visual analog scale of pain measurement (VAS) will be used.

2

Description
Anxiety
Timepoint
The intensity of anxiety in all three groups will be measured at 4 cm dilation (before the start of the intervention) and 20 minutes after the start of the intervention at 4 cm dilation, as well as at 6 and 8 cm.
Method of measurement
The intensity of anxiety will be measured with the Spielberger state-trait anxiety questionnaire.

3

Description
The length of the active phase
Timepoint
The time interval between4 cm dilatation to full cervical dilatation in the presence of at least 2 contractions in 10 minutes will be calculated based on hours and minutes during labor.
Method of measurement
In order to measure the length of the active phase of labor, the partograph diagram is drawn in the delivery room and the length of the active phase of labor will be calculated by the researcher.

Secondary outcomes

1

Description
Length of the second stage of labor
Timepoint
The length of this stage will be measured by the researcher by measuring the time interval between the complete dilatation of the cervix and the exit of the fetus in minutes.
Method of measurement
The length of this stage will be measured by the researcher with measuring the time of between the complete dilatation of the cervix and the exit of the fetus in minutes.

2

Description
Apgar Score
Timepoint
Apgar score will be calculated in the first and fifth minutes after birth.
Method of measurement
The Apgar table will be used to calculate the Apgar score.

Intervention groups

1

Description
Intervention group: In the aromatherapy group, gauze impregnated with 4 drops of Citrus aurantium aroma (Adonis Gol Daru Company-Iran) will be attached to the participants' collars. Gauzes will be changed every 30 minutes until 10 cm dilation. In addition, in order to avoid bias, for all participants in the aromatherapy group, grain-free adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then every 30 minutes and between uterine contractions, a gentle hand is placed on their ears, but these points will not be pressed.
Category
Treatment - Other

2

Description
Intervention group: In the auriculotherapy group, pressure on the main points of the ear in the external ear (point zero, shen men, sympathetic, thalamus) with the aim of reducing pain and anxiety and the primary points of the ear (uterus (C), uterus (E), Gonadotrophins, ovaries, pelvis, abdomen) ) with the aim of reducing pain and helping the progress of labor, is applied by a trained researcher who has completed the preliminary course of auriculotherapy in 22 hours under the supervision of the Iranian Midwifery Scientific Association. To prevent torsion, ericulotherapy is performed by one person for all research samples. First, the ears are cleaned using alcohol and is applied adhesives containing vacaria seeds for auriculotherapy by ZhongyanTaihe Company, which is available in the Iran . For 30 seconds between contractions, and finger pressure is applied on the vacaria seeds of right ear. After 30 minutes, the same points in the left ear are pressed for 30 seconds between contractions, and with finger pressure on the Vacaria seeds. The seeds are compressed alternately on the right or left ear every 30 minutes and each time for 30 seconds until the full dilation. Finger pressure on the seeds to the extent that the pain is bearable for the client. In order to avoid bias, in the auriculotherapy group, gauze impregnated with 4 drops of distilled water will be attached to the collar of all participants. Gauzes will be changed every 30 minutes until 10 cm dilation.
Category
Treatment - Other

3

Description
Control group: For all participants in the control group, seedless adhesives will be applied on four unrelated points (ankle, knee, tooth and jaw) of both ears. Then, every 30 minutes, a gentle hand is placed on one of their ears, but these points will not be pressed. In addition, for all participants in this group, a gauze soaked with 4 drops of distilled water will be attached to their collars. Gauzes will be changed every 30 minutes until 10 cm dilation
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences, Yazd
Full name of responsible person
Dr. Seyed Mehdi Hashemi Bajgani
Street address
Central Building of Shahid Sadougi University of Medical Sciences, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Web page address
https://ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Vahid Hosseini
Street address
The central building of Shiraz University of Medical Sciences, in front of Palestine Street, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Web page address
https://sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatane Eeftekhari Shah Abad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
The second door on the left, the second dead end on the right, Arash Ik Alley, Forty Alley, Ayatollah Khamenei Blvd., Yazd City
City
Yazd
Province
Yazd
Postal code
8916163468
Phone
+98 35 3821 3003
Fax
Email
eftekhary.fatane@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahboubeh Hajifoghaha
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۶۱۳۱۱۹
Phone
+98 71 3647 4254
Email
Foghaha2000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatane Eeftekhari Shah Abad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
The second door on the left, the second dead end on the right, Arash Ik Alley, Forty Alley, Ayatollah Khamenei Blvd., Yazd City
City
Yazd
Province
Yazd
Postal code
8916163468
Phone
+98 35 3821 3003
Fax
Email
eftekhary.fatane@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
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