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

Primary Purpose

LACTATION IN MOTHERS WITH PREMATURE NEWBORNS

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
aromatherapy massage
back massage
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for LACTATION IN MOTHERS WITH PREMATURE NEWBORNS focused on measuring AROMATHERAPY, MASSAGE, LACTATION, BREASTFEEDING

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • İstanbul University-Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aromatherapy massage group

back massage group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the amount of expressed milk
the amount of expressed milk by manual milking

Secondary Outcome Measures

Lactation symptoms evaluated after the massage sessions
Lactation symptoms in breasts

Full Information

First Posted
June 6, 2023
Last Updated
June 13, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05903872
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
LACTATION IN MOTHERS WITH PREMATURE NEWBORNS
Keywords
AROMATHERAPY, MASSAGE, LACTATION, BREASTFEEDING

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aromatherapy massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
back massage group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aromatherapy massage
Intervention Description
aromatherapy massage was applied using essential oils
Intervention Type
Other
Intervention Name(s)
back massage
Intervention Description
back massage was applied using only almond oil
Primary Outcome Measure Information:
Title
the amount of expressed milk
Description
the amount of expressed milk by manual milking
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Lactation symptoms evaluated after the massage sessions
Description
Lactation symptoms in breasts
Time Frame
twice a day for 3 days
Other Pre-specified Outcome Measures:
Title
maternal satisfaction survey
Description
satisfaction with the intervention
Time Frame
at the end of 3rd day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damla Nur Aksaray, MSc
Organizational Affiliation
Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul University-Cerrahpaşa
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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