NCT04589000

Brief Summary

The effect of acupressure in non-breastfeeding mothers after preterm cesarean delivery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

April 12, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

October 12, 2020

Last Update Submit

October 12, 2020

Conditions

AcupressureBreastfeeding

Keywords

acupressure, breastfeeding

Outcome Measures

Primary Outcomes (1)

  • the amount of breast milk

    The amount of milk will be checked twice a day 15 minutes after acupressure application

    3 days

Secondary Outcomes (2)

  • The time of onset of the first colostrum and the symptoms of the first milk in mothers

    3 days

  • Visual Analogue Satisfaction Patient Scale (VASPS) for Breastfeeding Satisfaction

    3 days

Study Arms (2)

acupressure

EXPERIMENTAL

Throughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes. 15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table.

Other: acupressure

control

NO INTERVENTION

No accupressure will be applied. Milk will be expressed for a total of 15 minutes, 1 time on the post-op 0th day, 2 times on the post-op 1st day and once on the post-op 2nd day for a total of 15 minutes and will be recorded in the milk measurement table.

Interventions

acupressureOTHER

Throughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes. 15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table.

acupressure

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers between the ages of 19-35,
  • Mothers who gave birth by cesarean operation,
  • Mothers who gave birth before 37th week of pregnancy,
  • Primiparous mothers,
  • Mothers whose baby is lying in NICU,
  • Mothers who do not have any chronic diseases,
  • Mothers who do not use breast milk enhancing drugs, vitamins and supplements,
  • Mothers who do not have any anotomic disorder in the breast,
  • Mothers who cannot breastfeed,
  • Mothers who do not have any injured skin, fracture, swelling or muscle pain, especially in the little finger.
  • Mothers without literacy problems, mental disabilities and communication problems,
  • Mothers living within the borders of the province of Van,
  • Mothers who agree to participate in the study.

You may not qualify if:

  • Mothers of premature newborns who cannot be fed breast milk,
  • Mothers who are multiparous,
  • Mothers with chronic disease,
  • Mothers who have a condition preventing milking,
  • Mothers whose language is insufficient in understanding and speaking Turkish,
  • Mothers who have breast abscess problems,
  • Mothers who have babies with congenital anomalies,
  • They are mothers who do not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sarı

Van, 65080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

esra sarı

CONTACT

05459027677esrasari@yyu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blind. Investigator know which participant have been assigned which group but participant don't know
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

April 12, 2019

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

TU(1)