Clinical trial NCT05903872: EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT
Official title: EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LACTATION IN MOTHERS WITH PREMATURE NEWBORNS
Keywords: AROMATHERAPY
MASSAGE
LACTATION
BREASTFEEDING
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The sample of the study included a total of 36 postpartum mothers with preterm newborns in 2 groups

18 mothers in aromatherapy massage group 18 mothers in back massage group
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled experimental study to investigate the effects of aromatherapy massage on lactation in non-breastfeeding mothers with premature newborns in neonatal intensive care unit.

The population of the research, was consisted of all mothers who gave birth preterm in a city hospital in Istanbul between October 2022- April 2023. The sample of the study included a total of 36 mothers (18 in aromatherapy group, 18 in the massage group) who were randomly selected among the mothers who were over 18 years of age, had preterm (\<37 weeks) cesarean section, had a single pregnancy, were on the first postpartum day, were asked to express their milk because of the baby's condition, and volunteered to participate in the study.

The data of the study were collected with Participant Characteristics Form, Depression-Anxiety-Stress Scale (DAS-21), Lactation Onset Symptoms Evaluation Form, Milking Follow-Up Form and Visual Analog Scale (VAS) satisfaction evaluation form.

The Participant Characteristics Form and the Depression Anxiety Stress Scale were administered to all mothers within the first 6-8 hours post-operatively, and manual milking training was given. For three days, twice a day (15 minutes each), aromatherapy massage was applied with a mixture of lavender, fennel and frankincense essential oils in almond oil as a carrier oil, while mothers in the massage group were only massaged with almond oil, which is only the carrier oil. Lactation symptoms were evaluated after the massage in both groups and the expressed milk amount was recorded after milking both breasts for at least 15 minutes. In addition, all mothers expressed their milk 8 times a day and recorded the total amount of milk in 24 hours. After the last application, their satisfaction with the application was evaluated with VAS. Descriptive statistical methods, chi-square, Mann Whitney and Friedman tests were used to evaluate the data.


Eligibility criteria: Inclusion Criteria:

* the mothers who were over 18 years of age, had preterm (\<37 weeks) cesarean section, had a single pregnancy, were on the first postpartum day, were asked to express their milk because of the baby's condition, and volunteered to participate in the study.

Exclusion Criteria:

* those with breast problems,
* who have allergic reaction to aromatherapy oils,
* using supplements for milk production,
* those who do not like aromatherapy oils or massage
* mothers who do not want to continue tthe study,
* developing postpartum health problems
* and mothers who cannot adapt to manual milking

Primary outcomes:
measure: the amount of expressed milk
timeFrame: up to 24 hours
Secondary outcomes:
measure: Lactation symptoms evaluated after the massage sessions
timeFrame: twice a day for 3 days
Other outcomes:
measure: maternal satisfaction survey
timeFrame: at the end of 3rd day
Locations:
city: İstanbul
country: Turkey
facility: İstanbul University-Cerrahpaşa
Study officials:
affiliation: Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student
name: Damla Nur Aksaray, MSc
role: PRINCIPAL_INVESTIGATOR
References: