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

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT05903872
Collaborator
(none)
36
1
2
6
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: aromatherapy massage
  • Other: back massage
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 groupThe 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)
Primary Purpose:
Supportive Care
Official Title:
EFFECTS OF AROMATHERAPY MASSAGE ON LACTATION IN NON-BREASTFEEDING MOTHERS WITH PREMATURE NEWBORNS IN NEONATAL INTENSIVE CARE UNIT
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Apr 1, 2023
Actual Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: aromatherapy massage
aromatherapy massage was applied using essential oils

Active Comparator: 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.

Other: back massage
back massage was applied using only almond oil

Outcome Measures

Primary Outcome Measures

  1. the amount of expressed milk [up to 24 hours]

    the amount of expressed milk by manual milking

Secondary Outcome Measures

  1. Lactation symptoms evaluated after the massage sessions [twice a day for 3 days]

    Lactation symptoms in breasts

Other Outcome Measures

  1. maternal satisfaction survey [at the end of 3rd day]

    satisfaction with the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul University-Cerrahpaşa İstanbul Turkey

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Damla Nur Aksaray, MSc, Istanbul University-Cerrahpaşa Women Health and Gynecologic Nursing Master Student

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
İlkay Güngör Satılmış, Associate Professor, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT05903872
Other Study ID Numbers:
  • IGungorSatilmis
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by İlkay Güngör Satılmış, Associate Professor, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2023