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The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section

Primary Purpose

Breastfeeding, Engorgement of Breast Associated With Childbirth, Postpartum

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oketani massage
Sponsored by
Agri Ibrahim Cecen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding focused on measuring breastfeeding, Engorgement, Oketani massage

Eligibility Criteria

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

Inclusion criteria for the study: Delivery by cesarean section Single and live birth, 38-40 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 Exclusion criteria from the study: 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

Sites / Locations

  • Agri Ibrahim Cecen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oketani massage group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2023
Last Updated
June 12, 2023
Sponsor
Agri Ibrahim Cecen University
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1. Study Identification

Unique Protocol Identification Number
NCT05903846
Brief Title
The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section
Official Title
The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agri Ibrahim Cecen University

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
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.
Detailed Description
The research was carried out in two groups, namely the octopus massage group and the control group. Oketani Massage Group: 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 engorgement and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale. Control Group: 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 engorgement a and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Engorgement of Breast Associated With Childbirth, Postpartum
Keywords
breastfeeding, Engorgement, Oketani massage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Massage was applied to the Oketani massage group by a midwife working in the clinicThe outcome assessor does not know who the groups are.
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oketani massage group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Oketani massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breast engorgement assessment scale
Description
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.
Time Frame
postpartum 48 hours from birth
Title
LATCH breastfeeding diagnostic scale
Description
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.
Time Frame
postpartum 48 hours from birth

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers giving birth and breastfeeding were included in the study.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for the study: Delivery by cesarean section Single and live birth, 38-40 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 Exclusion criteria from the study: 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
Facility Information:
Facility Name
Agri Ibrahim Cecen University
City
Agri
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section

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