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

• Sponsor: Esra SARI (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04589000
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.6
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acupressure; Breastfeeding	Other: acupressure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Masking Description: Single Blind. Investigator know which participant have been assigned which group but participant don't know
• Primary Purpose: Supportive Care
• Official Title: The Effect of Acupressure in Non-breastfeeding Mothers After Preterm Cesarean Delivery
• Actual Study Start Date: Apr 12, 2019
• Anticipated Primary Completion Date: Nov 30, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. the amount of breast milk [3 days]

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

Secondary Outcome Measures

1. The time of onset of the first colostrum and the symptoms of the first milk in mothers [3 days]

2. Visual Analogue Satisfaction Patient Scale (VASPS) for Breastfeeding Satisfaction [3 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Esra Sarı	Van		Turkey	65080

Sponsors and Collaborators

• Esra SARI

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Esra SARI, Research Assistant, Yuzuncu Yıl University
• ClinicalTrials.gov Identifier: NCT04589000
• Other Study ID Numbers: ESARI; Esra SARI
• First Posted: Oct 19, 2020
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Esra SARI, Research Assistant, Yuzuncu Yıl University: acupressure, breastfeeding

Study Results

No Results Posted as of Oct 19, 2020