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A comparative study of aromatherapy with rosewater and warm shower on the pain intensity of the active phase of labor in primiparous pregnant women.

Protocol summary

Study aim
The effect of aromatherapy with rosewater and warm shower on the intensity of active labor pain in primiparous women
Design
This study is a randomized controlled clinical trial with a parallel design (Phase II). The sample size is 108 participants (36 in each group). Participants will be randomly assigned to three groups. For this purpose, cards labeled A (aromatherapy with rosewater), B (warm shower), and C (control) will be prepared, and each participant will randomly select one card. The intensity of labor pain will be measured at cervical dilations of 4, 6, and 8 centimeters using the Visual Analogue Scale (VAS).
Settings and conduct
The study will be conducted at Gharazi Hospital in Malayer. Eligible participants will be screened and provide written informed consent, then randomly assigned to one of three groups using cards labeled A (aromatherapy), B (warm shower), and C (control). The primary outcome is labor pain intensity. To minimize bias, the outcome assessor will be blinded and will not be aware of group allocation.
Participants/Inclusion and exclusion criteria
Inclusion: Primiparous women aged 18–35, 37–42 weeks gestation, singleton, cephalic presentation, active labor (3–4 cm dilation), normal fetal heart rate. Exclusion: Drug addiction , Intrauterine growth restriction ,Diagnosed mental or anatomical disorder, allergy to rose water
Intervention groups
The intervention in the first group was 20 minutes of inhale the aroma of rose water at dilations of 4 cm, 6 cm, and 8 cm. In the second group, a hot shower with a temperature of 38-40 degrees was used in the lumbar and sacral region for 20 minutes at final dilations of 4 cm, 6 cm, and 8 cm. Routine maternity care is also used in the control group.
Main outcome variables
The intensity of labor pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241110063652N3
Registration date: 2025-10-17, 1404/07/25
Registration timing: registered_while_recruiting

Last update: 2025-10-17, 1404/07/25
Update count: 0
Registration date
2025-10-17, 1404/07/25
Registrant information
Name
zahra kohzad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6523 5751
Email address
zk.kohzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-17, 1404/07/25
Expected recruitment end date
2026-03-16, 1404/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of aromatherapy with rosewater and warm shower on the pain intensity of the active phase of labor in primiparous pregnant women.
Public title
The effect of aromatherapy with rosewater and hot showers on the intensity of pain in the active phase of labor in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women Women at the beginning of the active phase of labor Gestational age 37-42 weeks Singleton fetus Showing the embryo series
Exclusion criteria:
Fetal heart defect Drug addiction Intrauterine growth restriction Diagnosed mental or anatomical disorder
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to three groups by a third party who is not involved in the research protocol. On three cards marked with the letters C-A-B, where card A represents the aromatherapy with rosewater group, card B represents the hot shower group, and card C represents the control group. The samples are randomly assigned to three groups .The first patient to enter the study is given three cards, chooses Wiki, and is placed in one of the groups. The second is given two cards and is placed in one of the groups, and finally the third is placed in the third group, and from then on the samples are randomly placed in the three groups.
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 Hamadan University of Medical Sciences
Street address
Central Headquarters of Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2025-10-04, 1404/07/12
Ethics committee reference number
IR.UMSHA.REC.1404.569

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery

Primary outcomes

1

Description
Pain
Timepoint
Time points of primary outcome measurement: The intensity of labor pain will be measured at cervical dilatation of 4 cm, 6 cm, and 8 cm using the Visual Analogue Scale (VAS).
Method of measurement
Visual pain scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, participants were exposed to rose water aroma inhalation during three stages of labor, at cervical dilations of 4, 6, and 8 cm. In each stage, the participant sat in a comfortable semi-seated position and inhaled the natural aroma of rose water for 20 minutes through normal breathing. Five drops of pure rose water100% concentration, without chemical additive, were applied to a cotton ball placed in a small glass container approximately 30 cm from the participant’s nose to allow gradual evaporation. Room temperature was maintained between 24–26°C. The total exposure time was 60 minutes per participant, and no other pharmacological intervention was administered concurrently.
Category
Other

2

Description
Intervention group: In the second intervention group, participants received warm water showers directed to the lumbar and sacral areas during active labor at cervical dilations of 4, 6, and 8 cm. Each session lasted 20 minutes, for a total of 60 minutes per participant. Water temperature was maintained between 38–40°C using a thermometer. A handheld shower device with medium water pressure was used, held approximately 30 cm from the skin . Participants were in a comfortable seated or standing position, and a trained midwife continuously monitored water temperature and safety throughout the procedure.
Category
Other

3

Description
Control group: In the control group, participants received standard routine labor care, which included monitoring of maternal and fetal vital signs according to hospital protocol, assessment of labor progress, emotional support, non-pharmacological comfort measures (such as position changes and breathing techniques), and administration of medications if prescribed by the attending physician. No complementary interventions such as aromatherapy or hydrotherapy were applied in this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gharazi Malayer Hospital
Full name of responsible person
Zahra Kahzad
Street address
Opposite Melal Park, Above Nabuwwat Square
City
Malayer
Province
Hamadan
Postal code
65718-64953
Phone
+98 937 039 6712
Email
zk.kohzad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
5th Floor, Central Headquarters of Hamadan University of Medical Sciences, Pajhohesh Square, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
65178-38736
Phone
+98 81 3131 0000
Email
zk.kohzad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kohzad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajhohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 6523 5751
Email
zk.kohzad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kohzad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajhohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 6523 5751
Email
zk.kohzad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Kohzad
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajhohesh Sq.
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 21 6523 5751
Email
zk.kohzad@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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