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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04589000
Other study ID # ESARI
Secondary ID Esra SARI
Status Recruiting
Phase N/A
First received
Last updated
Start date April 12, 2019
Est. completion date December 30, 2020

Study information

Verified date October 2020
Source Yuzuncu Yil University
Contact esra sari
Phone 05459027677
Email esrasari@yyu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

One of the frequently encountered problems in breastfeeding is insufficient lactation. Numerous integrative treatments support to overcome this problem. This randomized controlled experimental study will conduct to determine the effect of acupressure on lactation in non-breastfeeding mothers following preterm caesarean delivery. The sample of the study will comprise of 64 mothers (32 acupressure-experimental and 32 control group), who will randomly select from among the primipara mothers of premature newborns delivered through cesarean section at Dursun Odabaş Medical Center of Van Yüzüncü Yıl University. Before the implementation, the Depression-Anxiety-Stress Scale and the Richard Campbell Sleep Quality Scale will apply. In post-operative three days, 15-minute acupressure will implement in the morning/evening, for acupressure-group mothers and pump milking will apply; control group mothers will only milked in mornings and evenings. Lactation symptoms will evaluate with Visual Analog Scale and acupressure satisfaction with Analog Patient Satisfaction Scale, and milk quantities will record.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date December 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
acupressure
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.

Locations

Country Name City State
Turkey Esra Sari Van

Sponsors (1)

Lead Sponsor Collaborator
Esra SARI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the amount of breast milk The amount of milk will be checked twice a day 15 minutes after acupressure application 3 days
Secondary The time of onset of the first colostrum and the symptoms of the first milk in mothers 3 days
Secondary Visual Analogue Satisfaction Patient Scale (VASPS) for Breastfeeding Satisfaction 3 days
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