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Protocol summary
A randomized clinical trial will be conducted on 80 mothers who present with labor pain to Hazrat Abolfazl Hospital in Kashmar and Allameh Bohlool Hospital in Gonabad. Participants will be selected using convenience sampling and randomly assigned using block randomization with blocks of four into two groups of 40: massage therapy with oleaster oil and massage therapy with lavender oil. Pain and anxiety intensity will be measured and recorded for both groups before and after the intervention using the Visual Analog Scale
A randomized clinical trial will be conducted on 80 mothers who present with labor pain to Allameh Bohlool Hospital in Gonabad. Participants will be selected using convenience sampling and randomly assigned using block randomization with blocks of four into two groups of 40: massage therapy with oleaster oil and massage therapy with lavender oil. Pain and anxiety intensity will be measured and recorded for both groups before and after the intervention using the Visual Analog Scale
A randomized clinical trial will be conducted on 80 mothers who present with labor pain to Hazrat Abolfazl Hospital in Kashmar and Allameh Bohlool Hospital in Gonabad. Participants will be selected using convenience sampling and randomly assigned using block randomization with blocks of four into two groups of 40: massage therapy with oleaster oil and massage therapy with lavender oil. Pain and anxiety intensity will be measured and recorded for both groups before and after the intervention using the Visual Analog Scale
کارآزمایی بالینی تصادفی‌سازی شده بر روی 80 مادر که با شکایت درد زایمان به بیمارستان حضرت ابوالفضل (ع) کاشمر و بیمارستان علامه بهلول گناباد مراجعه کردند انجام خواهد شد.شرکت کنندگان با استفاده از روش نمونه‌گیری در دسترس و با روش تصادفی با بلوک های 4 تایی تصادفی انتخاب و به دو گروه 40نفری ماساژ درمانی با روغن سنجد و روغن اسطوخودوس تقسیم می شوند.شدت درد و اضطراب با استفاده از مقیاس آنالوگ بصری برای هر دو گروه قبل و بعد از مداخله اندازه‌گیری و ثبت می شود
کارآزمایی بالینی تصادفی‌سازی شده بر روی 80 مادر که با شکایت درد زایمان به بیمارستان علامه بهلول گناباد مراجعه کردند انجام خواهد شد.شرکت کنندگان با استفاده از روش نمونه‌گیری در دسترس و با روش تصادفی با بلوک های 4 تایی تصادفی انتخاب و به دو گروه 40نفری ماساژ درمانی با روغن سنجد و روغن اسطوخودوس تقسیم می شوند.شدت درد و اضطراب با استفاده از مقیاس آنالوگ بصری برای هر دو گروه قبل و بعد از مداخله اندازه‌گیری و ثبت می شود
کارآزمایی بالینی تصادفی‌سازی شده بر روی 80 مادر که با شکایت درد زایمان به بیمارستان حضرت ابوالفضل (ع) کاشمر و بیمارستان علامه بهلول گناباد مراجعه کردند انجام خواهد شد.شرکت کنندگان با استفاده از روش نمونه‌گیری در دسترس و با روش تصادفی با بلوک های 4 تایی تصادفی انتخاب و به دو گروه 40نفری ماساژ درمانی با روغن سنجد و روغن اسطوخودوس تقسیم می شوند.شدت درد و اضطراب با استفاده از مقیاس آنالوگ بصری برای هر دو گروه قبل و بعد از مداخله اندازه‌گیری و ثبت می شود
General information
empty
Conversion from two centers to one center
Conversion from two centers to one center
empty
تبدیل از دو مرکزی به یک مرکزی
تبدیل از دو مرکزی به یک مرکزی
Recruitment centers
#1
Name of recruitment center - English: Hazrat Abolfazl Hospital of Kashmar
Name of recruitment center - Persian: بیمارستان حضرت ابوالفضل کاشمر
Full name of responsible person - English: Simin Ashrafi
Full name of responsible person - Persian: سیمین اشرفی
Street address - English: Moallem Town - Sina Square
Street address - Persian: شهرک معلم -میدان سینا
City - English: Kashmar
City - Persian: کاشمر
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9671975839
Phone: +98 51 5523 8300
Fax:
Email: ashrafisimin5@gmail.com
Web page address:
Name of recruitment center - English: Hazrat Abolfazl Hospital of Kashmar Name of recruitment center - Persian: بیمارستان حضرت ابوالفضل کاشمر Full name of responsible person - English: Simin Ashrafi Full name of responsible person - Persian: سیمین اشرفی Street address - English: Moallem Town - Sina Square Street address - Persian: شهرک معلم -میدان سینا City - English: Kashmar City - Persian: کاشمر Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9671975839 Phone: +98 51 5523 8300 Fax: Email: ashrafisimin5@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of massage with oleaster oil and massage with lavender oil on anxiety and labor pain in pregnant women
Design
A phase 3, randomized, non-blinded, parallel-group, controlled clinical trial on 80 patients. RAND function of Microsoft Excel
Settings and conduct
A randomized clinical trial will be conducted on 80 mothers who present with labor pain to Allameh Bohlool Hospital in Gonabad. Participants will be selected using convenience sampling and randomly assigned using block randomization with blocks of four into two groups of 40: massage therapy with oleaster oil and massage therapy with lavender oil. Pain and anxiety intensity will be measured and recorded for both groups before and after the intervention using the Visual Analog Scale
Participants/Inclusion and exclusion criteria
Healthy, alive, single fetus with no anomalies
First to third delivery
fetal weight 2500 to 4000 grams
Fetal lie is longitudinal and the presenting part is cephalic
Gestational age 37 and 41 weeks
Body mass index at delivery 18.5 and 29.9
Regular uterine contractions three times in ten minutes
Cervical dilation of at least 3–4 centimeter
Informed consent
;
allergy to oleaster and lavender
Skin infection or lesion in the massage area
History of pregnancy or delivery complications
Use of herbal medications during or before delivery
Use of other non-pharmacological methods for reducing labor pain
Any maternal disability
Having a midwife or doula
Maternal addiction
psychiatric disorder
Occurrence of a stressful event in the past 6 months
assisted reproductive techniques
Pregnancy or medical complications such as preeclampsia, diabetes, active bleeding, severe cardiac disorders
Intervention groups
Intervention:massage with oleaster oil;Control:massage with lavender oil
Main outcome variables
Labor pain intensity;Labor anxiety intensity
General information
Reason for update
Conversion from two centers to one center
Acronym
IRCT registration information
IRCT registration number:IRCT20260205068764N1
Registration date:2026-05-25, 1405/03/04
Registration timing:prospective
Last update:2026-06-14, 1405/03/24
Update count:1
Registration date
2026-05-25, 1405/03/04
Registrant information
Name
Simin Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 7271
Email address
ashrafisimin5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-09, 1405/03/19
Expected recruitment end date
2026-09-20, 1405/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain in pregnant women
Public title
Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A healthy, alive, single fetus with no anomalies
The mother has no pregnancy-related or medical complications such as preeclampsia, diabetes, active bleeding, or severe cardiac disorders that would prevent massage or continuation of natural labor
The delivery is the first to the third
The estimated fetal weight according to the most recent ultrasound is 2500 to 4000 grams
The fetal lie is longitudinal and the presenting part is cephalic
The gestational age is between 37 and 41 weeks
Body mass index at delivery is between 18.5 and 29.9
Regular uterine contractions three times in ten minutes
Cervical dilation of at least 3-4 centimeters
Informed consent to participate in the research
Exclusion criteria:
History of allergy to oleaster (Elaeagnus angustifolia) and lavender
Skin infection or lesion in the massage area
History of infertility or use of assisted reproductive technique
Occurrence of a stressful event in the past 6 months (such as divorce, death of first-degree relatives of the mother
Psychiatric disorder based on maternal self-report
Maternal addiction by maternal self-report
Having an accompanying midwife or doula
Any maternal disability (blindness, deafness, hearing loss, motor impairment
Use of other non-pharmacological methods for reducing labor pain
Use of herbal medications during or before delivery
History of pregnancy or delivery complications (neonatal death, dystocia, stillbirth
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The method is as follows: first, six possible blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed, and each block is assigned a number from 1 to 6. Then, using a random number table in Excel, a number between 1 and 6 is randomly selected, and participants are allocated to groups according to the block corresponding to that number. This process is repeated until the total sample size is reached. Allocation concealment is performed by an individual, and to conceal the allocation method, the blocks are placed in sealed envelopes.
Furthermore, to ensure homogeneity between the two groups regarding the number of primiparous women, participants are stratified based on their current delivery status (first delivery, etc.). The block randomization method is then implemented within each stratum
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Gonabad, side of Asian Road
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۷۱۹۷۵۸۲۰
Approval date
2026-05-15, 1405/02/25
Ethics committee reference number
IR.GMU.REC.1405.016
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labor pain intensity
Timepoint
before the intervention
Method of measurement
Visual Analogue Scale
2
Description
Labor pain intensity
Timepoint
after the intervention at dilation of 3–4 cm
Method of measurement
Visual Analogue Scale
3
Description
Labor pain intensity
Timepoint
after the intervention at dilation of 5-7cm
Method of measurement
Visual Analogue Scale
4
Description
Labor pain intensity
Timepoint
after the intervention at dilation of 8-10cm
Method of measurement
Visual Analogue Scale
5
Description
Anxiety intensity
Timepoint
Before the intervention
Method of measurement
Visual Analogue Scale
6
Description
Anxiety intensity
Timepoint
after the intervention at dilation of 3–4 cm
Method of measurement
Visual Analogue Scale
7
Description
Anxiety intensity
Timepoint
after the intervention at dilation of 5-7 cm
Method of measurement
Visual Analogue Scale
8
Description
Anxiety intensity
Timepoint
after the intervention at dilation of 8-10 cm
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groupMassage with 10 drops of oleaster oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm
Category
Treatment - Drugs
2
Description
Control group:Massage with 10 drops of lavender oil from Giahe Kala Company, which has the Sib-e Salamat (health mark) and necessary health permits, is 100% pure and organic, free from additives and preservatives, packaged in antibacterial containers with a volume of 30 cc. The massage will be performed using effleurage (gentle rubbing) with moderate pressure. Simultaneously with the onset of contractions, the mother will be placed in a side-lying position, and a full-back massage will be given for 20 minutes during three stages of cervical dilation: 3–4 cm, 5–7 cm, and 8–10 cm
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Bohlool Hospital of Gonabad
Full name of responsible person
Simin Ashrafi
Street address
Here is the English translation of the address starting from the end (reverse order): **"Allameh Bohlool Gonabadi Hospital, Parastar Boulevard, Saadi Street
City
Gonabad
Province
Razavi Khorasan
Postal code
9671975820
Phone
+98 51 5723 6832
Email
ashrafisimin5@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Momen Moghaddam
Street address
Vice-Chancellery for Education and Research, Gonabad University of Medical Sciences, on the margin of the Asian Highway
City
Gonabad
Province
Razavi Khorasan
Postal code
9671974116
Phone
+98 51 5722 3028
Email
ashrafisimin5@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Simin Ashrafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 32, Second Floor, Second Door on the Left, Emam Reza 26, Jomhouri 40
City
Kashmar
Province
Razavi Khorasan
Postal code
9671975820
Phone
+98 51 5523 7271
Email
ashrafisimin5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Simin Ashrafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 32, Second Floor, Second Door on the Left, Emam Reza 26, Jomhouri 40
City
Kashmar
Province
Razavi Khorasan
Postal code
9671975820
Phone
+98 51 5523 7271
Email
ashrafisimin5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Simin Ashrafi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 32, Second Floor, Second Door on the Left, Emam Reza 26, Jomhouri 40
City
Kashmar
Province
Razavi Khorasan
Postal code
9671975820
Phone
+98 51 5523 7271
Email
ashrafisimin5@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