BreastfeedingNCT05599542
The Effect of Hypno-breastfeeding and Solution-oriented Approach
A study testing Solution-oriented approach and Hypno-breastfeeding in people with Breastfeeding and Breast Milk Expression, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Motivation, which is also necessary for the breastfeeding behavior of mothers in the postpartum period, can affect the success and continuity of breastfeeding. This study was conducted to evaluate the effects of hypno-breastfeeding and solution-oriented approach on breastfeeding motivation and insufficient milk… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breast Milk Expression
- What is being tested?
- Solution-oriented approach and Hypno-breastfeeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2021to 30 Aug 2022
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- 35 weeks and above healthy pregnancy
- No communication barrier
- No diagnosed psychiatric problem
- Normal delivery
- No complications of mother and baby
Who cannot join
- Multiple pregnancy
- 34 weeks and below pregnancy
- Communication barrier
- Clinical diagnosis of psychiatric problem
- Cesarean delivery
- Complications in mother and baby
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Hypno-breastfeeding and Solution-oriented Approach on Mothers' Breastfeeding Motivation and Perception of Insufficient Milk: Randomize Controlled Study
Motivation, which is also necessary for the breastfeeding behavior of mothers in the postpartum period, can affect the success and continuity of breastfeeding. This study was conducted to evaluate the effects of hypno-breastfeeding and solution-oriented approach on breastfeeding motivation and insufficient milk perception in mothers. It is a randomized controlled experimental study. The sample of the study consisted of 90 women who met the inclusion criteria, three groups as the hypno-breastfeeding group, the solution-focused approach group and the control group.
Read the detailed description
Hypno-breastfeeding, which is a mind-body program that helps to increase breast milk production, is a therapy that includes emotion control, pain management, and positive suggestions that define the mother's role in the breastfeeding process. This method, in comfortable, calm and natural conditions, is effective in increasing the amount of milk by eliminating phobias, anxiety and negative thoughts in the mind of the mother, relaxing and concentrating on breastfeeding. The solution-oriented approach, on the other hand, is a therapeutic counseling practice that does not deal with the problem itself, but focuses on the past successes of the individual and the times when they did not experience the problem. In solution-oriented approach, which argues that each individual can solve their problems with their own internal resources by only directing them to the positive, it focuses on the strengths of the person instead of underlining the weaknesses. No study has been found on the effect of solution-oriented approach on breastfeeding process in the perinatal period. However, there are studies that show that the application of solution-oriented approach, which will make a different contribution to midwifery philosophies, is effective in reducing the fear of birth and reducing the anxiety of mothers who have anxiety about premature baby care. It is thought that with the effective use of the hypno-breastfeeding method and solution-oriented approach by midwives and health personnel, the perception of insufficient milk of mothers during the breastfeeding process can be reduced and breastfeeding motivation will be positively affected. In this context, this study aimed to determine the effect of hypno-breastfeeding and solution-oriented approach on breastfeeding motivation and insufficient milk perception.
- Conditions
- Breastfeeding, Breast Milk Expression
- Being tested
- Solution-oriented approach, Hypno-breastfeeding
- Keywords
- Hypno-breastfeeding, Solution-oriented approach
- Medical subject headings
- Breast Feeding, Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution-oriented approachOther
A preliminary assessment of the pregnant woman's thoughts on breastfeeding was made and the EARS (Eliciting, Amplifying, Reinforcing and Start Over) process was applied. Eliciting, Amplifying, Reinforcing and Start Over process guides the second and subsequent sessions in a sequential order. The Eliciting, Amplifying, Reinforcing and Start Over technique reminds the counselor of the basic concepts of solution-oriented approach and its explanation is as follows;
Hypno-breastfeedingOther
A preliminary assessment was made about the pregnant woman's thoughts on breastfeeding. In the hypno-nursing philosophy, affirmation, relaxation, imagination and visualization techniques were used in order to positively affect the subconscious mind during the breastfeeding process.
| Study group | Role | What they receive |
|---|---|---|
| Solution-oriented approach group | Experimental | A preliminary assessment of the pregnant woman's thoughts on breastfeeding was made and the EARS (Eliciting, Amplifying, Reinforcing and Start Over) process was applied. Eliciting, Amplifying, Reinforcing and Start Over process guides the second and subsequent sessions in a sequential order. Receives: Other: Solution-oriented approach; Other: Hypno-breastfeeding |
| Hypno-breastfeeding group | Experimental | A preliminary assessment was made about the pregnant woman's thoughts on breastfeeding. In the hypno-nursing philosophy, affirmation, relaxation, imagination and visualization techniques were used in order to positively affect the subconscious mind during the breastfeeding process. Receives: Other: Solution-oriented approach; Other: Hypno-breastfeeding |
| control group | Other | Data were collected with the Introductory Information Form at the first interview (admission to the postpartum service) with the women in the control group. Post-test data were collected with Primiparous Breastfeeding Motivation Scale and Insufficient Milk Perception Scale at 16-24 hours postpartum. Receives: Other: Solution-oriented approach; Other: Hypno-breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primiparous Breastfeeding Motivation Scale
The scale, which was validated and reliable in Turkish by Akçay and Demirgöz Bal, was developed by Stockdale et al. to determine the factors affecting breastfeeding motivation in primiparous women. It was determined that the scale consisting of 29 items was 7-point Likert type and had 4 sub-dimensions. These sub-dimensions are: the value attached to breastfeeding, self-efficacy, perceived midwife support, and success expectancy. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases. A cutoff in the assessment of the scale There is no value or total score. Evaluation by summing the scores obtained in each subgroup in the scale is done. As the score increases, the characteristics of the subgroup and therefore the motivation increase.
Measured: 5 months
Secondary outcomes (1)
Insufficient Milk Perception Scale
The scale, developed by McCarter-Spaulding, consists of 6 questions to determine inadequate perception of breast milk. The Turkish validity and reliability of the scale was performed by Gökçeoğlu. The first question of the scale questions whether the mother perceives her milk adequately and is answered as "yes" or "no". Other questions of the scale are aimed at measuring the perception of inadequacy of milk. These questions are scored between 0-10 ("0" is perceived as completely inadequate, "10" is perceived as completely sufficient). A score between 0-50 can be obtained from the scale, and a high total score indicates an increased perception of milk sufficiency.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start7 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Aug 2022
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 Cukurova 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif DAĞLI, Cukurova University
- Investigators
- Feyza Aktaş Reyhan, Dr., Study chair, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599542
- Sponsor's protocol ID
- hypno-breastfeeding
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 31 Oct 2022
- 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypno-breastfeeding and Solution-oriented Approach on Mothers' Breastfeeding Motivation and Perception of Insufficient Milk: Randomize Controlled Study
- ClinicalTrials.gov ID
- NCT05599542
- Acronym / sponsor ID
- hypno-breastfeeding
- Conditions
- Breastfeeding, Breast Milk Expression
- Keywords
- Hypno-breastfeeding, Solution-oriented approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 31 Oct 2022 (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.
Motivation, which is also necessary for the breastfeeding behavior of mothers in the postpartum period, can affect the success and continuity of breastfeeding. This study was conducted to evaluate the effects of hypno-breastfeeding and solution-oriented approach on breastfeeding motivation and insufficient milk perception in mothers. It is a randomized controlled experimental study. The sample of the study consisted of 90 women who met the inclusion criteria, three groups as the hypno-breastfeeding group, the solution-focused approach group and the control group.
Detailed description
Hypno-breastfeeding, which is a mind-body program that helps to increase breast milk production, is a therapy that includes emotion control, pain management, and positive suggestions that define the mother's role in the breastfeeding process. This method, in comfortable, calm and natural conditions, is effective in increasing the amount of milk by eliminating phobias, anxiety and negative thoughts in the mind of the mother, relaxing and concentrating on breastfeeding. The solution-oriented approach, on the other hand, is a therapeutic counseling practice that does not deal with the problem itself, but focuses on the past successes of the individual and the times when they did not experience the problem. In solution-oriented approach, which argues that each individual can solve their problems with their own internal resources by only directing them to the positive, it focuses on the strengths of the person instead of underlining the weaknesses. No study has been found on the effect of solution-oriented approach on breastfeeding process in the perinatal period. However, there are studies that show that the application of solution-oriented approach, which will make a different contribution to midwifery philosophies, is effective in reducing the fear of birth and reducing the anxiety of mothers who have anxiety about premature baby care. It is thought that with the effective use of the hypno-breastfeeding method and solution-oriented approach by midwives and health personnel, the perception of insufficient milk of mothers during the breastfeeding process can be reduced and breastfeeding motivation will be positively affected. In this context, this study aimed to determine the effect of hypno-breastfeeding and solution-oriented approach on breastfeeding motivation and insufficient milk perception.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solution-oriented approach group | Experimental | Other: Solution-oriented approach, Other: Hypno-breastfeedingA preliminary assessment of the pregnant woman's thoughts on breastfeeding was made and the EARS (Eliciting, Amplifying, Reinforcing and Start Over) process was applied. Eliciting, Amplifying, Reinforcing and Start Over process guides the second and subsequent sessions in a sequential order. |
| Hypno-breastfeeding group | Experimental | Other: Solution-oriented approach, Other: Hypno-breastfeedingA preliminary assessment was made about the pregnant woman's thoughts on breastfeeding. In the hypno-nursing philosophy, affirmation, relaxation, imagination and visualization techniques were used in order to positively affect the subconscious mind during the breastfeeding process. |
| control group | Other | Other: Solution-oriented approach, Other: Hypno-breastfeedingData were collected with the Introductory Information Form at the first interview (admission to the postpartum service) with the women in the control group. Post-test data were collected with Primiparous Breastfeeding Motivation Scale and Insufficient Milk Perception Scale at 16-24 hours postpartum. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Single pregnancy
- 35 weeks and above healthy pregnancy
- No communication barrier
- No diagnosed psychiatric problem
- Normal delivery
Key exclusion criteria (6 listed)
- Multiple pregnancy
- 34 weeks and below pregnancy
- Communication barrier
- Clinical diagnosis of psychiatric problem
- Cesarean delivery
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 |
|---|---|---|
| Solution-oriented approachA preliminary assessment of the pregnant woman's thoughts on breastfeeding was made and the EARS (Eliciting, Amplifying, Reinforcing and Start Over) process was applied. Eliciting, Amplifying, Reinforcing and Start Over process guides the second and subsequent sessions in a sequential order. The Eliciting, Amplifying, Reinforcing and Start Over technique reminds the counselor of the basic concepts of solution-oriented approach and its explanation is as follows; | Other | Hypno-breastfeeding group, Solution-oriented approach group, control group |
| Hypno-breastfeedingA preliminary assessment was made about the pregnant woman's thoughts on breastfeeding. In the hypno-nursing philosophy, affirmation, relaxation, imagination and visualization techniques were used in order to positively affect the subconscious mind during the breastfeeding process. | Other | Hypno-breastfeeding group, Solution-oriented approach group, control group |
Primary outcome
Primiparous Breastfeeding Motivation Scale
Time frame: 5 months
The scale, which was validated and reliable in Turkish by Akçay and Demirgöz Bal, was developed by Stockdale et al. to determine the factors affecting breastfeeding motivation in primiparous women. It was determined that the scale consisting of 29 items was 7-point Likert type and had 4 sub-dimensions. These sub-dimensions are: the value attached to breastfeeding, self-efficacy, perceived midwife support, and success expectancy. As the score obtained from each sub-dimension increases, the breastfeeding motivation level of that sub-dimension increases. A cutoff in the assessment of the scale There is no value or total score. Evaluation by summing the scores obtained in each subgroup in the scale is done. As the score increases, the characteristics of the subgroup and therefore the motivation increase.
1 secondary outcome
Insufficient Milk Perception Scale
Time frame: 5 months
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 31 Oct 2022.
- 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.
Feyza Aktaş Reyhan, Dr. study chair
Kütahya Health Sciences 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 Solution-oriented approach and Hypno-breastfeeding in people with Breastfeeding and Breast Milk Expression, run by Cukurova 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 6 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 31 Oct 2022. 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?
Primiparous Breastfeeding Motivation Scale (time frame: 5 months). 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 31 Oct 2022; AzTrials last refreshed its copy on 2 Nov 2026.