NCT05903846

Brief Summary

The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. The universe of the study consisted of mothers who were hospitalized in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023 and gave birth by cesarean section. The Open Epi calculation tool was used to determine the sample of the study. The sample calculation was made on the average score differences in the Open Epi info program. Accordingly, it was planned to include 106 mothers, 53 of whom were in the control group and 53 in the massage group. Considering the sample loss to be experienced during data collection, a total of 116 mothers, 58 in the control group and 58 in the massage group, were included in the study. Randomization of the groups participating in the study was made as simple randomization using the www.random.org site. Introductory Characteristics Questionnaire, oketany massage follow-up form, breast engorgement assessment scale and LATCH breastfeeding diagnostic measurement tool were used to collect the research data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months 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 2, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Last Updated

February 10, 2026

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 2, 2023

Last Update Submit

February 6, 2026

Conditions

Keywords

breastfeedingEngorgementOketani massage

Outcome Measures

Primary Outcomes (2)

  • Breast engorgement assessment scale

    The scale is scored from 1 to 6. On the scale, "1" is evaluated as no soft change, while "6" is expressed as very hard and very sensitive. If the score from the scale is higher than 4, it means that there is breast fullness.

    postpartum 48 hours from birth

  • LATCH breastfeeding diagnostic scale

    by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.

    postpartum 48 hours from birth

Study Arms (2)

Oketani massage group

EXPERIMENTAL

According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast engorgement assessment scale and the LATCH breastfeeding diagnostic scale.

Other: Oketani massage

Control group

NO INTERVENTION

No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast fengorgement assessment scale and the LATCH breastfeeding diagnostic scale.

Interventions

The part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless.

Oketani massage group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMothers giving birth and breastfeeding were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Delivery by cesarean section
  • Single and live birth,
  • Giving birth between weeks
  • Not having a mental or physical disability that prevents breastfeeding,
  • The baby does not need neonatal intensive care
  • The baby does not have a condition that prevents breastfeeding
  • Sharing the same room with the baby
  • Agreeing to participate in the research

You may not qualify if:

  • Refusal to participate in the study
  • Giving birth normally
  • Giving birth prematurely
  • Having a mental and physical disability that prevents breastfeeding
  • Being 18 years of age or younger
  • Transferring the baby to the neonatal intensive care unit
  • Having a condition that prevents breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agri Ibrahim Cecen University

Ağrı, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingHyperemia

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Massage was applied to the Oketani massage group by a midwife working in the clinicThe outcome assessor does not know who the groups are.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Oketani massage,The part between the breast and the base of the lower pectoral muscle is called the "oketani". It is a manual massage technique developed to encourage breastfeeding in breastfeeding problems such as insufficient milk production and mastitis. It is a massage that stimulates the breast, relaxes it and is painless. There are 8 different stages in massage. Each set lasts 1 minute, the massage continues for 15-20 minutes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 2, 2023

First Posted

June 15, 2023

Study Start

November 1, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

February 10, 2026

Record last verified: 2023-06

Locations