NCT05903872

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 6, 2023

Last Update Submit

June 13, 2023

Conditions

Keywords

AROMATHERAPYMASSAGELACTATIONBREASTFEEDING

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

EXPERIMENTAL

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.

Other: aromatherapy massage

back massage group

ACTIVE COMPARATOR

For 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.

Other: back massage

Interventions

aromatherapy massage was applied using essential oils

aromatherapy massage group

back massage was applied using only almond oil

back massage group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Damla Nur Aksaray, MSc

    Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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
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

Locations