The Effect of Acupressure in Non-breastfeeding Mothers After Preterm Cesarean Delivery

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

Study Overview

• Status: Unknown
• Conditions: Breastfeeding; Acupressure
• Intervention / Treatment: Other: acupressure

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65080
    • Recruiting
    • Esra Sarı
    • Contact: esra sarı; Phone Number: 05459027677

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
NO_INTERVENTION: control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the amount of breast milk	The amount of milk will be checked twice a day 15 minutes after acupressure application	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Esra SARI

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2019
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: acupressure, breastfeeding
• Other Study ID Numbers: ESARI; Esra SARI (REGISTRY: ESARI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No