EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 6, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedJune 15, 2023
June 1, 2023
6 months
June 6, 2023
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the amount of expressed milk
the amount of expressed milk by manual milking
up to 24 hours
Secondary Outcomes (1)
Lactation symptoms evaluated after the massage sessions
twice a day for 3 days
Other Outcomes (1)
maternal satisfaction survey
at the end of 3rd day
Study Arms (2)
aromatherapy massage group
EXPERIMENTALFor 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.
back massage group
ACTIVE COMPARATORFor three days, twice a day (15 minutes each), back massage was applied using only 1 tablespoon of almond oil (a carrier oil) in order to evaluate the effect of essential oils.
Interventions
aromatherapy massage was applied using essential oils
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damla Nur Aksaray, MSc
Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 6, 2023
First Posted
June 15, 2023
Study Start
October 1, 2022
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share