NCT07076953

Brief Summary

The perception of insufficient milk is quite common in mothers during the postpartum period. Especially mothers who have given birth for the first time tend to external factors more due to lack of experience. Studies mention many nonpharmacological methods to prevent this. Some of these are hypnobreastfeeding, hot application, breast massage, aromatherapy. There are many studies on breast massage to increase milk to date. However, no study with cherry seed has been identified. By eliminating the deficiency in the literature and proving the effect of cherry seed breast massage on insufficient milk perception and lactation start-up symptoms, it will be ensured that breastfeeding is not terminated early, and this research is needed considering the perspective of improving mother and baby health by breastfeeding for the first 6 months. The study will be conducted in a single-blind randomized control design. The study will be conducted in Konya Medova Hospital. A total of 54 puerpera will be included in the study, including the cherry seed massage intervention group (18), the hand massage intervention group (18), and the control group (18). The study data will be collected using the Introductory Information Form, the Insufficient Milk Perception Scale, and the Visual Analog Scale (Vas) to Evaluate Mothers' Lactation Initiation Symptoms. The intervention group data will be collected in the first five minutes, 30 minutes, 1 hour, and 2 hours after birth. SPSS 23 (IBM, Inc., Armonk, NY, USA) program will be used in the analysis and evaluation of the data. The results obtained will be tested at a significance level of p\<0.05 and two-way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 31, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 8, 2025

Last Update Submit

July 19, 2025

Conditions

Keywords

LaborLactationCherry pit massagePerception of insufficient milkManual massageBreastfeedingMidwife support

Outcome Measures

Primary Outcomes (1)

  • Insufficient Milk Perception Scale

    The Turkish validity and reliability study was conducted by Gökçeoğlu and Küçükoğlu (2014). The scale consists of 6 questions. The first question, which asks whether the mother perceives her milk supply as sufficient, is answered with a "yes" or "no" question. The other 5 questions measure the perception of insufficient milk supply and are scored from 0 to 10. The scale is scored from 0 to 50. Cronbach's alpha was determined as 0.81 in the original scale and was found to be 0.82 in the Turkish validity and reliability study. In this study, Cronbach's alpha values were found to be highly reliable at 0.757 for the pretest, highly reliable at 0.881 for the third stage of labor, highly reliable at 0.91 for the first hour, and highly reliable at 0.931 for the second hour.

    Between 5-35 minutes after birth,in the first hour after birth, in the second hour after birth, for fifteen minutes

Secondary Outcomes (1)

  • Lactation Evaluation Form

    Between 5-35 minutes after birth,in the first hour after birth, in the second hour after birth, for fifteen minutes

Study Arms (3)

Hand Massage Group

ACTIVE COMPARATOR

Data collection in the study was conducted in a planned and structured manner, starting from the third stage of labor. Participants in the intervention groups (manual massage and cherry pit massage) received two 15-minute massages, one in the first hour and one in the second hour postpartum, after the third stage of labor was completed. During the treatment, the mother's position was adjusted appropriately, with privacy and comfort prioritized, and intervention was interrupted in the event of pain or discomfort. During the data collection process, signs of the onset of lactation (breast fullness, milk leakage, tingling, etc.) were observed within the first 24 hours after birth for all three groups (manual massage, cherry pit massage, and the control group), and mothers' perception of insufficient milk supply was assessed using structured questionnaires and scales.

Other: Manual Breast Massage

Cherry Pit Massage Group

ACTIVE COMPARATOR

Data collection in the study was conducted in a planned and structured manner, starting from the third stage of labor. Participants in the intervention groups (manual massage and cherry pit massage) received two 15-minute massages, one in the first hour and one in the second hour postpartum, after the third stage of labor was completed. During the treatment, the mother's position was adjusted appropriately, with privacy and comfort prioritized, and intervention was interrupted in the event of pain or discomfort. During the data collection process, signs of the onset of lactation (breast fullness, milk leakage, tingling, etc.) were observed within the first 24 hours after birth for all three groups (manual massage, cherry pit massage, and the control group), and mothers' perception of insufficient milk supply was assessed using structured questionnaires and scales.

Other: Cherry Seed Massage Group

Control Group

NO INTERVENTION

No intervention other than routine care was applied to the control group of the study, and research data were collected at simultaneous intervals with the intervention groups.

Interventions

In the third stage of labor, a cherry pit massage was applied for 15 minutes in the first and second hours. Cherry pits were added to a silk bag to prevent damage to the skin during the massage. The massage application steps were applied as indicated in the hand massage

Cherry Pit Massage Group

Manual massage was applied for 15 minutes during the third stage of labor, first and second hour.Manual breast massage steps; Step 1: The breast tissue under and near the armpit is compressed and released like a water pump. Step 2: Pressure is applied to the breast tissue. Step 3: The breasts are massaged using the fingers and pressed with small circular movements. It is moved clockwise and counterclockwise around the breast and towards the areola with light touches. Step 4: Both hands are placed under the breast; the breast is moved up and down, left and right, forward and backward. Step 5: One hand is placed under the breast and the other hand is on the breast; the hands are moved in the opposite direction and a rolling motion is applied to the breast.

Hand Massage Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age,
  • weeks of pregnancy,
  • Primiparous,
  • Able to read and write Turkish,
  • Volunteer women were included in the study

You may not qualify if:

  • Women who have a risky pregnancy (such as IVF pregnancy, multiple pregnancy, preeclampsia),
  • Women who smoke or use alcohol,
  • Women who have a physiological or anatomical obstacle that may prevent lactation,
  • Women who have infectious diseases such as HIV, Hepatitis B, Hepatitis C, which are known to be transmitted through breast milk, were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay Üniversitesi

Konya, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistician was blinded in the study. The researcher blinding was not done because he was the implementer. In order to prevent bias in the evaluation of the data; groups A, B and C were coded by an independent academician other than the researcher and the data were analyzed by an independent statistician. After the analysis and interpretation of the data were completed, the codes of the intervention and control groups of the study were revealed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There is a manual massage group, a cherry seed massage group , a control group. The Effect of Cherry Pitted Massage on Primiparous Pregnant Women During Labor on Postpartum Lactation Onset Symptoms and Insufficient Milk Perception
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 22, 2025

Study Start

October 31, 2024

Primary Completion

February 15, 2025

Study Completion

April 18, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations