EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT

NCT ID: NCT05903872

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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LACTATION IN MOTHERS WITH PREMATURE NEWBORNS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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aromatherapy massage group

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.

Group Type EXPERIMENTAL

aromatherapy massage

Intervention Type OTHER

aromatherapy massage was applied using essential oils

back massage group

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.

Group Type ACTIVE_COMPARATOR

back massage

Intervention Type OTHER

back massage was applied using only almond oil

Interventions

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aromatherapy massage

aromatherapy massage was applied using essential oils

Intervention Type OTHER

back massage

back massage was applied using only almond oil

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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İlkay Güngör Satılmış

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Damla Nur Aksaray, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student

Locations

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İstanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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IGungorSatilmis

Identifier Type: -

Identifier Source: org_study_id

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