The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women

NCT06811298 | Completed

• 1 other identifier: 478-478--25
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aims to examine the effects of breast massage and virtual reality applications on breastfeeding in women after cesarean delivery. The study will include mothers aged 18-45, who have delivered a healthy baby via cesarean section at an Obstetrics and Gynecology Department of a University Training and Research Hospital located in the Aegean Region. Participants will have no health issues preventing breastfeeding, will have previously received breastfeeding counseling, and will be included after providing informed consent following the explanation of the study's objectives. The primary research questions addressed in this study are as follows: Does breast massage applied to women after cesarean delivery affect breastfeeding? Does the application of virtual reality to women after cesarean delivery affect breastfeeding? The research groups will be randomly assigned into three groups-virtual reality, breast massage, and control-before any interventions are applied. Randomization will be performed using the website www.randomizer.org to determine the group allocation for each participant. In this study, 31 mothers in the virtual reality group will be shown a 15-minute virtual reality video, depicting a river and forest, viewed through a virtual reality headset, in order to create a relaxing and calming environment. This will be done on post-operative day 0, at the 3rd hour, and at the 24th hour. In the breast massage group, 32 mothers will receive breast massage for 15 minutes, administered by the researchers at the same time points (post-operative day 0, 3rd hour, and 24th hour). After the interventions, mothers will be asked to breastfeed their babies, and the babies will be weighed both before and after breastfeeding. The control group will receive no intervention and will receive standard care (31 women). Infant weight measurements will also be taken at the same times in the control group. After the interventions, the LATCH Breastfeeding Charting System and Documentation Tool, along with the Breastfeeding Self-Efficacy Scale, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. A descriptive information form will be used to determine the sociodemographic and obstetric features of the participants in the study.

Conditions

Lactation; Lactation Disorder - Postpartum Condition or Complication; Lactation Disorder With Baby Delivered

Keywords

lactation; lactation disorder-postpartum condition or complication; lactation disorder with baby delivered

Outcome Measures

Primary Outcomes (3)

• The amount of milk produced during breastfeeding

  After the interventions (post-operative day 0, at the 3rd hour, and at the 24th ), mothers will be asked to breastfeed their babies, and the babies will be weighed both before and after breastfeeding.

  Post op 24 hour

• Breastfeeding self-efficacy assessment

  After the interventions along with the Breastfeeding Self-Efficacy Scale, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. The Breastfeeding Self-Efficacy Scale (Dennis and Faux, 1999) is a 33-item scale developed to assess how confident mothers feel about breastfeeding. All items in the scale have positive connotations. As a result of internal consistency analysis, items with a total-item correlation below 0.60 were removed, and a 14-item short form was created. The Cronbach's alpha value for this short form is 0.94. The scale is a 5-point Likert type, with scores ranging from 14 to 70, and a higher score indicates greater breastfeeding self-efficacy. The Turkish adaptation was carried out by Aluş-Tokat and Okumuş (2010), and the Cronbach's alpha value was found to be 0.86.

  Post op 24 hour

• Breastfeeding evaluation

  After the interventions, the LATCH Breastfeeding Charting System and Documentation Tool, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. The LATCH Breastfeeding Diagnostic Tool, developed in 1986, is a tool created by adapting the APGAR score system in terms of its scoring method. This measurement tool was developed to make an objective diagnosis of breastfeeding, identify breastfeeding problems, create an educational plan, establish a common language among healthcare professionals, and be used in research (to determine breastfeeding success in longitudinal studies). The tool consists of five evaluation criteria, and the first letters of these criteria combine to form the acronym LATCH. Each item is evaluated between 0-2 points. The maximum score that can be obtained from the scale is 10. In Turkey, its reliability was studied by Yenal and Okumuş (2003), and and the Cronbach's alpha value was determined to be 0.95.

  Post op 24 hour

Study Arms (3)

Breast Massage

EXPERIMENTAL

In the breast massage group, a breast massage will be applied for 15 minutes.

Virtual Reality

EXPERIMENTAL

The virtual reality group's participants will be shown a 15-minute virtual reality video depicting a river and a forest, with the aim of creating a relaxing and calming environment.

Other: Virtual Reality

Control Group

NO INTERVENTION

No intervention will be applied.

Interventions

Breast massage OTHER

The breast massage group will receive a 15-minute breast massage administered by the researchers at postoperative Day 0, Hour 3, and Hour 24. The aim of this intervention is to increase lactation. Following the interventions, mothers will be asked to breastfeed their infants, and the infants will be weighed both before and after breastfeeding.

Virtual Reality OTHER

Postpartum women who undergo virtual reality headset application will watch a 15-minute river and forest video using the headset on postoperative day 0, hour 3, and hour 24. This intervention aims to help them feel in a relaxing and soothing environment and to increase lactation. Following the interventions, mothers will be asked to breastfeed their infants, and the infants will be weighed both before and after breastfeeding.

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-45 years
• Singleton pregnancy in the current gestation
• Having received breastfeeding counseling during the current pregnancy
• Gestational age between the 38th and 42nd week
• Newborn birth weight between 2500-4000 grams
• No requirement for intensive care for either the mother or the newborn

You may not qualify if:

• Multiple pregnancy in the current gestation
• Any mental or physical health issues that would prevent breastfeeding
• Uterine atony
• Use of medications that would require stopping breastfeeding
• Any condition that interferes with breastfeeding
• Congenital anomalies in the newborn (such as cleft palate or cleft lip) that could affect breastfeeding
• Requirement for intensive care for either the newborn or the mother

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University

Uşak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Şeyma Çatalgöl, Dr

  Uşak University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: January 31, 2025
• Primary Completion: June 6, 2025
• Study Completion: June 12, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)