Clinical trial NCT06811298: The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women
Official title: The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Intervention with Virtual Reality:

The use of virtual reality (VR) applications in breastfeeding support after cesarean delivery represents a rare approach in which psychological relaxation is combined with physiological effects. In our study, VR facilitates the relaxation of new mothers through visual and auditory natural landscapes, while also exploring how this technology alleviates stress and anxiety during the breastfeeding process and its effects on milk production, thus filling a unique gap in the literature. Although VR has typically been used in the treatment of psychological disorders in other studies, systematically addressing its concrete effects on breastfeeding provides a new perspective.

The Role of Post-Cesarean Breast Massage in Early Lactation:

The enhancement of lactation after cesarean delivery is generally limited to breastfeeding counseling and psychological support. However, breast massage, as a direct physiological intervention, may play an important role in overcoming physiological barriers caused by cesarean delivery. Given the limited number of studies examining the mechanisms through which breast massage increases milk production, investigating its early-stage effects, particularly in supporting lactation after cesarean delivery, offers an innovative contribution.

Multidimensional and Comprehensive Evaluation Methods:

Rather than using a single measurement tool, our study will combine different scales, such as the LATCH Breastfeeding Charting System and the Postnatal Breastfeeding Self-Efficacy Scale, and will evaluate lactation by weighing the babies before and after the interventions. This multidimensional approach will assess not only milk production and breastfeeding success but also critical factors such as the mother's self-confidence and emotional state. This comprehensive data collection allows for a deeper understanding not only of the effectiveness of individual interventions but also of mothers' overall experiences during the breastfeeding process.

Personalized Intervention Approach:

In our research, the interventions and follow-up processes applied to each group reflect a personalized approach. Both virtual reality and breast massage will help individuals relax and breastfeed more effectively, while the control group will only undergo milk production tracking. This provides a solid foundation for comparing the effectiveness of these two methods. Moreover, highlighting the differences between the groups will contribute to the development of tailored care strategies for mothers who have undergone cesarean delivery.

These unique elements will not only contribute to the existing literature but will also bring a new perspective to clinical applications. The combination of virtual reality and physical massage offers an innovative approach that can provide valuable and unique findings related to the post-cesarean breastfeeding process.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The amount of milk produced during breastfeeding
timeFrame: Post op 24 hour
measure: Breastfeeding self-efficacy assessment
timeFrame: Post op 24 hour
measure: Breastfeeding evaluation
timeFrame: Post op 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: Uşak University
Study officials:
affiliation: Uşak University
name: Şeyma Çatalgöl, Dr
role: PRINCIPAL_INVESTIGATOR
References: