LactationNCT06811298
The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women
A study testing Breast massage and Virtual Reality in people with Lactation and Lactation Disorder - Postpartum Condition or Complication, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation, Lactation Disorder - Postpartum Condition or Complication, Lactation Disorder With Baby Delivered
- What is being tested?
- Breast massage and Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2025to 12 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women: A Randomized Controlled Trial
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?
Read more
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.
Read the 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.
- Conditions
- Lactation, Lactation Disorder - Postpartum Condition or Complication, Lactation Disorder With Baby Delivered
- Being tested
- Breast massage, Virtual Reality
- Keywords
- lactation, lactation disorder-postpartum condition or complication, lactation disorder with baby delivered
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast massageOther
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 RealityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality |
| Control Group | No intervention | No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post op 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start31 Jan 2025
- Primary completion6 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Çatalgöl, Uşak University
- Investigators
- Şeyma Çatalgöl, Dr, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811298
- Sponsor's protocol ID
- 478-478--25
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06811298
- Acronym / sponsor ID
- 478-478--25
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Massage | Experimental | –In the breast massage group, a breast massage will be applied for 15 minutes. |
| Virtual Reality | Experimental | Other: Virtual RealityThe 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. |
| Control Group | No intervention | –No intervention will be applied. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast massageThe 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. | Other | – |
| Virtual RealityPostpartum 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. | Other | Virtual Reality |
Primary outcome
The amount of milk produced during breastfeeding
Time frame: Post op 24 hour
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.
Breastfeeding self-efficacy assessment
Time frame: Post op 24 hour
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.
Breastfeeding evaluation
Time frame: Post op 24 hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şeyma Çatalgöl, Dr principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast massage and Virtual Reality in people with Lactation and Lactation Disorder - Postpartum Condition or Complication, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of milk produced during breastfeeding (time frame: Post op 24 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.