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IRCT20241110063652N3 IRCT 2025-10-17 Hamedan University of Medical Sciences The effect of aromatherapy with rosewater and hot showers on the intensity of pain in the active phase of labor in pregnant women A comparative study of aromatherapy with rosewater and warm shower on the pain intensity of the active phase of labor in primiparous pregnant women. 2025-10-17 anticipated 108 Complete https://irct.ir/trial/86701 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. N/A Delivery. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is under review
public Zahra Kohzad
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajhohesh Sq.
Hamedan Iran (Islamic Republic of) 6517838736 +98 21 6523 5751 zk.kohzad@gmail.com Hamedan University of Medical Sciences scientific Zahra Kohzad
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajhohesh Sq.
Hamedan Iran (Islamic Republic of) 6517838736 +98 21 6523 5751 zk.kohzad@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Primiparous women Women at the beginning of the active phase of labor Gestational age 37-42 weeks Singleton fetus Showing the embryo series 18 years 35 years Female Fetal heart defect Drug addiction Intrauterine growth restriction Diagnosed mental or anatomical disorder O80 Encounter for full-term uncomplicated delivery Other Other Other 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. 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. 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. 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. Hamedan University of Medical Sciences Approved 2025-10-04 Ethics Committee of Hamadan University of Medical Sciences Central Headquarters of Hamadan University of Medical Sciences, Shahid Fahmideh Blvd. Hamadan Hamadan Iran (Islamic Republic of)