The Effect of Hypno-breastfeeding and Solution-oriented Approach

October 14, 2022 updated by: Elif DAĞLI, Cukurova University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Single pregnancy
  • 35 weeks and above healthy pregnancy
  • No communication barrier
  • No diagnosed psychiatric problem
  • Normal delivery
  • No complications of mother and baby

Exclusion Criteria:

  • Multiple pregnancy
  • 34 weeks and below pregnancy
  • Communication barrier
  • Clinical diagnosis of psychiatric problem
  • Cesarean delivery
  • Complications in mother and baby

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solution-oriented approach group
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.
Other: Solution-oriented approach
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;
Other: Hypno-breastfeeding
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.
Experimental: Hypno-breastfeeding group
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.
Other: Solution-oriented approach
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;
Other: Hypno-breastfeeding
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.
Other: control group
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.
Other: Solution-oriented approach
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;
Other: Hypno-breastfeeding
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insufficient Milk Perception Scale
Time Frame: 5 months
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Feyza Aktaş Reyhan, Dr., Kutahya Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Hypno-Breastfeeding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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