Protocol summary
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Study aim
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Determining the effect of massage with oleaster oil and massage with lavender oil on anxiety and labor pain in pregnant women
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Design
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A phase 3, randomized, non-blinded, parallel-group, controlled clinical trial on 80 patients. RAND function of Microsoft Excel
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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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
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Intervention groups
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Intervention:massage with oleaster oil;Control:massage with lavender oil
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Main outcome variables
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Labor pain intensity;Labor anxiety intensity
General information
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Reason for update
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Conversion from two centers to one center
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Acronym
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IRCT registration information
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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
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Registration date
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2026-05-25, 1405/03/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-06-09, 1405/03/19
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Expected recruitment end date
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2026-09-20, 1405/06/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain in pregnant women
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Public title
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Comparison of the effects of massage with Elaeagnus angustifolia oil and massage with lavender oil on anxiety and labor pain
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-05-15, 1405/02/25
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Ethics committee reference number
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IR.GMU.REC.1405.016
Health conditions studied
1
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Description of health condition studied
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Anxiety
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ICD-10 code
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F06.4
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ICD-10 code description
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Anxiety disorder due to known physiological condition
2
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Description of health condition studied
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Labor pain
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Labor pain intensity
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Timepoint
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before the intervention
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Method of measurement
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Visual Analogue Scale
2
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Description
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Labor pain intensity
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Timepoint
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after the intervention at dilation of 3–4 cm
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Method of measurement
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Visual Analogue Scale
3
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Description
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Labor pain intensity
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Timepoint
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after the intervention at dilation of 5-7cm
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Method of measurement
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Visual Analogue Scale
4
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Description
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Labor pain intensity
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Timepoint
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after the intervention at dilation of 8-10cm
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Method of measurement
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Visual Analogue Scale
5
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Description
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Anxiety intensity
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Timepoint
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Before the intervention
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Method of measurement
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Visual Analogue Scale
6
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Description
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Anxiety intensity
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Timepoint
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after the intervention at dilation of 3–4 cm
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Method of measurement
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Visual Analogue Scale
7
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Description
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Anxiety intensity
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Timepoint
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after the intervention at dilation of 5-7 cm
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Method of measurement
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Visual Analogue Scale
8
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Description
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Anxiety intensity
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Timepoint
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after the intervention at dilation of 8-10 cm
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gonabad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available