BreastfeedingNCT06199245
The Effect of Emotional Freedom Technique on Breastfeeding Success and Self-Efficacy
A study testing emotional freedom technique experimental group in people with Breastfeeding and Self Efficacy, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of emotional freedom technique (EFT) on breastfeeding success and self-efficacy in primiparous women in the early postpartum period who had a cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Self Efficacy, Cesarean Delivery Affecting Fetus
- What is being tested?
- emotional freedom technique experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Jun 2024
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between the ages of 18-35,
- Primiparous and giving birth by cesarean section,
- Having a spontaneous pregnancy,
- Wound, scar, infection etc. in the tapping area. without conditions,
- Women who do not have verbal communication problems
Who cannot join
- Being outside the age range of 18-35
- Has any problem that prevents communication,
- Those who gave birth normally
- Having had a high-risk pregnancy,
- Women who want to leave the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol Mega University Hospital
Istanbul, 34214
Eda YÜZÜGÜLER, +905445856200, eda.yuzuguler@std.medipol.edu.tr
Pınar IRMAK VURAL, Asst. Prof.
About this study
Official title: The Effect of Emotional Freedom Technique on Breastfeeding Success and Self-Efficacy in Primiparous Women in the Early Postpartum Period Who Had a Cesarean Delivery
This study was planned to determine the effect of emotional freedom technique (EFT) on breastfeeding success and self-efficacy in primiparous women in the early postpartum period who had a cesarean delivery.
Read the detailed description
Breast milk is an easily digestible, natural food that reduces the morbidity and mortality of the newborn and contains the fluid, energy and nutrients necessary for its physical, spiritual and mental development. Breastfeeding not only has a biological effect on the mother and baby, but also has an emotional effect and has many immunological, psychological, social and economic benefits for both mother and baby. Therefore, it is of great importance that the baby be fed exclusively with breast milk for the first 6 months and that breastfeeding continues until the age of 2.
EFT, a needle-free and emotional form of acupuncture, is an energy technique that emerged from the idea that "The cause of all negative emotions is the disruption in the body's energy system." EFT; It can be safely applied to individuals of all ages, including the elderly, pregnant women and children. When looking at the literature, no studies were found regarding breastfeeding and EFT. It has been observed that primiparous women, especially those who have had a cesarean section, have difficulty breastfeeding. It is thought that breastfeeding will be reinforced and improved with EFT, which helps to eliminate negative emotions in the subconscious and create a positive mood.
- Being tested
- emotional freedom technique experimental group
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional freedom technique experimental groupOther
Participants in the experimental group, who had a cesarean delivery on the first postpartum day, filled out the sociodemographic and obstetric information form and the Breastfeeding Self-Efficacy Scale, and then were asked to breastfeed their babies and their breastfeeding was evaluated with the Bristol Breastfeeding Evaluation Scale. The participant was then asked to score her breastfeeding between 0 and 10 to evaluate her Subjective Units of Disturbance Scala (SUD) score. The next evaluation was made 2 hours after the participant received breastfeeding training, the Bristol Breastfeeding Rating Scale score was obtained, and the SUD was scored again after 2 rounds of Emotional Freedom Techniques (EFT) application. Finally, at the end of the day, 2 rounds of EFT application were performed by taking the SUD score before the EFT session, and after the application, the participant's Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Evaluation Scale and SUD scores were recorded.
| Study group | Role | What they receive |
|---|---|---|
| emotional freedom technique experimental group | Experimental | Emotional Freedom Technique was applied to the participants in the experimental group, who had a cesarean section on the first postpartum day and agreed to participate in the study, and their breastfeeding self-efficacy and breastfeeding success were evaluated. Receives: Other: emotional freedom technique experimental group |
| control group | No intervention | Participants in the control group were selected from the same sample group, but no intervention was applied. Breastfeeding self-efficacy and breastfeeding success were evaluated after a routine hospital procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bristol Breastfeeding Rating Scale
This scale measures breastfeeding success. The scale is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". Each item is scored between 0-2 points. The lowest score from the scale is 0, the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
Measured: one day
Secondary outcomes (2)
breastfeeding self-efficacy scale
This scale measures breastfeeding self-efficacy. The scale is a 5-point Likert type scale. The minimum score that can be obtained from the scale is 14, the maximum score is 70, and the scale has no cut-off point.
Measured: one day
Subjective Units of Disturbance Scala
This scale is used in energy therapies and evaluates the individual's discomfort. The scale is scored between 0 and 10, where "0" means no discomfort and "10" means unbearable discomfort and is scored between 0 and 10. As the number value increases, the discomfort experienced by the person becomes more severe.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Nov 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- An experimental group in which EFT was applied and a control group in which the routine procedure was applied.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Yuzuguler, Medipol University
- Investigators
- Pınar IRMAK VURAL, Asst. Prof., Study director, thesis advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199245
- Sponsor's protocol ID
- IMU-HEM-EY-01
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 12 Jan 2024
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique on Breastfeeding Success and Self-Efficacy in Primiparous Women in the Early Postpartum Period Who Had a Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06199245
- Acronym / sponsor ID
- IMU-HEM-EY-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 10 Jan 2024 (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 study was planned to determine the effect of emotional freedom technique (EFT) on breastfeeding success and self-efficacy in primiparous women in the early postpartum period who had a cesarean delivery.
Detailed description
Breast milk is an easily digestible, natural food that reduces the morbidity and mortality of the newborn and contains the fluid, energy and nutrients necessary for its physical, spiritual and mental development. Breastfeeding not only has a biological effect on the mother and baby, but also has an emotional effect and has many immunological, psychological, social and economic benefits for both mother and baby. Therefore, it is of great importance that the baby be fed exclusively with breast milk for the first 6 months and that breastfeeding continues until the age of 2.
EFT, a needle-free and emotional form of acupuncture, is an energy technique that emerged from the idea that "The cause of all negative emotions is the disruption in the body's energy system." EFT; It can be safely applied to individuals of all ages, including the elderly, pregnant women and children. When looking at the literature, no studies were found regarding breastfeeding and EFT. It has been observed that primiparous women, especially those who have had a cesarean section, have difficulty breastfeeding. It is thought that breastfeeding will be reinforced and improved with EFT, which helps to eliminate negative emotions in the subconscious and create a positive mood.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An experimental group in which EFT was applied and a control group in which the routine procedure was applied.
| Arm | Type | Receives |
|---|---|---|
| emotional freedom technique experimental group | Experimental | Other: emotional freedom technique experimental groupEmotional Freedom Technique was applied to the participants in the experimental group, who had a cesarean section on the first postpartum day and agreed to participate in the study, and their breastfeeding self-efficacy and breastfeeding success were evaluated. |
| control group | No intervention | –Participants in the control group were selected from the same sample group, but no intervention was applied. Breastfeeding self-efficacy and breastfeeding success were evaluated after a routine hospital procedure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-35,
- Primiparous and giving birth by cesarean section,
- Having a spontaneous pregnancy,
- Wound, scar, infection etc. in the tapping area. without conditions,
- Women who do not have verbal communication problems
Key exclusion criteria (5 listed)
- Being outside the age range of 18-35
- Has any problem that prevents communication,
- Those who gave birth normally
- Having had a high-risk pregnancy,
- Women who want to leave the study
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 |
|---|---|---|
| emotional freedom technique experimental groupParticipants in the experimental group, who had a cesarean delivery on the first postpartum day, filled out the sociodemographic and obstetric information form and the Breastfeeding Self-Efficacy Scale, and then were asked to breastfeed their babies and their breastfeeding was evaluated with the Bristol Breastfeeding Evaluation Scale. The participant was then asked to score her breastfeeding between 0 and 10 to evaluate her Subjective Units of Disturbance Scala (SUD) score. The next evaluation was made 2 hours after the participant received breastfeeding training, the Bristol Breastfeeding Rating Scale score was obtained, and the SUD was scored again after 2 rounds of Emotional Freedom Techniques (EFT) application. Finally, at the end of the day, 2 rounds of EFT application were performed by taking the SUD score before the EFT session, and after the application, the participant's Breastfeeding Self-Efficacy Scale, Bristol Breastfeeding Evaluation Scale and SUD scores were recorded. | Other | emotional freedom technique experimental group |
Primary outcome
Bristol Breastfeeding Rating Scale
Time frame: one day
This scale measures breastfeeding success. The scale is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing". Each item is scored between 0-2 points. The lowest score from the scale is 0, the highest score is 8. Low scores indicate that breastfeeding is not effective, while high scores indicate that breastfeeding is effective.
2 secondary outcomes
breastfeeding self-efficacy scale
Time frame: one day
Subjective Units of Disturbance Scala
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- 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.
Pınar IRMAK VURAL, Asst. Prof. study director
thesis advisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional freedom technique experimental group in people with Breastfeeding and Self Efficacy, run by Medipol 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eda Yüzügüler, student (+905445856200, eda.yuzuguler@std.medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bristol Breastfeeding Rating Scale (time frame: one day). 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 12 Jan 2024.