The Impact of Virtual Reality-Assisted Relaxation on Breastfeeding Self-Efficacy and Breast Milk Production in Mothers of Premature Infants: A Randomized Controlled Trial
Phase: NA
Conditions: Lactation, Breastfeeding, Premature Birth, Maternal Stress, Self-Efficacy
Sponsor: Kocaeli University

 
 
 
The Impact of Virtual Reality-Assisted Relaxation on Breastfeeding Self-Efficacy and 
Breast Milk Production in Mothers of Premature Infants: A Randomized Controlled Trial 
 
 
 
NCT Number: Pending 
Document Date: January 2, 2026 
 
 
 

STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN (SAP) 
1. BACKGROUND AND RATIONALE 
Breast milk is essential for premature infants' health and development. However, mothers of 
preterm infants often experience high stress levels due to the Neonatal Intensive Care Unit 
(NICU) environment, which can negatively affect milk production and breastfeeding 
confidence. This study aims to investigate whether Virtual Reality (VR) based relaxation can 
increase milk volume and self-efficacy. 
2. OBJECTIVES 
Primary Objective: To compare the daily breast milk volume between the VR intervention 
group and the control group over three days. 
Secondary Objective: To evaluate the effect of VR relaxation on breastfeeding self-efficacy 
scores. 
3. STUDY DESIGN 
Type: Randomized Controlled Trial (Parallel Group). 
Setting: A Level II Neonatal Intensive Care Unit. 
Duration: 3 consecutive days for each participant. 
4. PARTICIPANT SELECTION 
Inclusion: Primiparous mothers of infants born at 32-35 weeks of gestation, delivered via C-
section, willing to express milk. 
Exclusion: Systemic/psychiatric diseases, use of galactagogues, or visual/hearing impairments. 
Sample Size: 44 participants (22 Intervention, 22 Control). 
5. INTERVENTION PROTOCOL 
Experimental Group: Participants use a VR headset to watch a 10-minute nature video with 
classical music in a quiet room. Immediately after, a trained researcher performs manual milk 
expression for at least 20 minutes. 
Control Group: Participants sit in the same quiet room for 10 minutes without VR. Then, the 
same manual milk expression procedure is performed by the researcher. 

Timing: All sessions occur between 12:00 and 14:00 to ensure hormonal consistency. 
6. STATISTICAL ANALYSIS PLAN (SAP) 
• Data will be analyzed using SPSS software. 
• Descriptive Statistics: Mean, standard deviation, median, and percentages will be used. 
• Normality Test: Shapiro-Wilk or Kolmogorov-Smirnov. 
• Comparison: Mann-Whitney U test for comparing the two independent groups. 
• Friedman test for evaluating changes over the 3-day period within groups. 
• Spearman’s correlation to examine the relationship between variables. 
• Significance Level: p < 0.05. 
 
 
Prepared by: 
Assistant Professor Suzi Özdemir, RM, PhD 
Kocaeli University, Faculty of Health Sciences, Midwifery Department 
suzi.ozdemir@kocaeli.edu.tr