Breast FeedingNCT06713109
The Effect of Breastfeeding Counselling with Motivational Inter-viewing Technique on Breastfeeding Problems and Anxiety
A study testing Motivational interview techniques in people with Breast Feeding and Anxiety, run by semiha izgordu at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to investigate the effect of motivational interviewing technique on breastfeeding problems and loss. H1:The breastfeeding problems score of the mothers who received motivational interviewing was lower than the mothers who received standard care. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Anxiety, Motivational Interviews
- What is being tested?
- Motivational interview techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a healthy 1-3 month old baby
- Being identified as having a breastfeeding problem
- To be at least primary school graduate
- To be able to communicate by telephone
- To come to the Family Health Centre for motivational talks
Who cannot join
- Having a baby with anomalies
- Having a baby younger than 1 month and older than 3 months
- Having a medical illness that prevents breastfeeding
- Communication problems
- Not accepting motivational interviewing
- The presence of any psychiatric illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara Üniversitesi Pendik Eğitim Aile Sağlığı Merkezi
Istanbul, tuzla, 34860
About this study
Official title: Motivasyonel Görüşme Il Verilen Emzirme Danışmanlığının Emzirme Sorunu Ve Kaygıya Etkisi
The primary aim of this study was to investigate the effect of motivational interviewing technique on breastfeeding problems and loss.
H1:The breastfeeding problems score of the mothers who received motivational interviewing was lower than the mothers who received standard care.
H 2: The anxiety level score of mothers who received motivational interviewing is lower than that of mothers who received standard care.
H3: The rate of exclusive breastfeeding of mothers who received motivational interviewing is higher than that of mothers who received standard care.
Read the detailed description
The data elements to be used in the study are as follows:
'Personal Information Form (Appendix-1)', "Breastfeeding Problems Assessment Scale (Appendix-2)" to determine the problems experienced by mothers regarding breastfeeding, and "State Anxiety Scale (Appendix-3)" to determine the anxiety level of mothers will be used to collect the data. 'Informed Consent Form (Appendix-4)' will be filled in and permission to participate in the study will be obtained.
Appendix 1- Personal Information Form A personal information form was prepared by reviewing the literature (Gölbaşı et al.) The information form questioning the socio-demographic, obstetric and breastfeeding characteristics of the mothers was prepared by the researcher and consisted of 19 items in total.
Appendix-2 Breastfeeding Problems Assessment Scale (BPSAS) Originally named 'Breastfeeding Experience Scale', the ESBS was developed by Karen Wambach in 1990 to evaluate mothers' breastfeeding experiences . The Turkish validity and reliability of the scale was conducted in 2019 . The original scale has a 5-point Likert type and consists of 5 sub-dimensions and 30 items. The scale consists of two parts. The first part consists of 18 items and evaluates breastfeeding problems. The second part consists of items 19-30 and assesses mothers' weaning experiences and formula supplementation practices. The Turkish version of the scale includes only the first part and consists of 18 items and 5 sub-dimensions. The 5 sub-dimensions of the scale (mechanical concerns; 16, 6, 4, 11, 14, process concerns; 12, 9, 8, 5, 3, milk insufficiency concerns; 13, 15, 10, breast concerns; 2, 1, 7, social concerns; 18, 17) were determined by confirmatory factor analysis. Scale items are graded as 1; not at all, 2; mild, 3; moderate, 4; severe, 5; unbearable. Each item is scored between 1 and 5. The minimum and maximum scores that can be obtained from the scale are 18-90. High scores obtained from the scale indicate that breastfeeding problems are severe. Cronbach's alpha coefficient for the evaluation of the reliability of the 18 items in the Breastfeeding Problems Assessment Scale was found to be 0.776. Cronbach's alpha values of the scale sub-dimensions; mechanical concerns; 0.852, process concerns; 0.712, milk insufficiency concerns; 0.766, breast concerns; 0.748, social concerns; 0.789 were found. It was found that there was no difference between the test-retest measurements of the scale and its invariance over time was determined. It was determined that the Breastfeeding Problems Assessment Scale is an appropriate measurement tool for assessing the problems of breastfeeding mothers in Turkish society.
Appendix 3- State Anxiety Inventory (STAI State Anxiety Inventory) State Anxiety Scale is a self-assessment questionnaire consisting of short statements. The State Anxiety Scale requires the individual to describe how he/she feels at a certain moment and under certain conditions and to answer by taking into account his/her feelings about the situation he/she is in. It consists of 20 questions in total.
The feelings or behaviours expressed in the items of the state anxiety scale consist of 1) not at all, 2) a little, 3) a lot and 4) completely according to the severity of the experience. Developed in 1964 by Spielber-ger and Gorsuch, the inventory aims to measure trait and state anxiety levels in normal and non-normal individuals.
After the adaptation and standardisation of the scale into Turkish by Öner and Le Compte in 1974-1977, the inventory was used in studies involving Turkish youth and adult groups.
There are two types of statements in the scale. These can be called (1) direct or straight statements and (2) re-verse statements. Direct statements express negative emotions, whereas reversed statements express positive emotions. When scoring these second type of statements, those with a weight value of 1 are converted to 4 and those with a weight value of 4 are converted to 1. In direct statements, answers with a value of 4 indicate that anxiety is high. In inverted statements, answers with a value of 1 indicate high anxiety and answers with a value of 4 indicate low anxiety. The expression 'I am restless' can be shown as an example of direct statements and the expression 'I feel calm' can be shown as an example of inverted statements. In this case, if an option with a weight of 4 is selected for the expression 'I feel restless' and an option with a weight of 1 is selected for the expression 'I feel calm', these answers reflect high anxiety. There are ten inverted statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20.
In the reversed statements, the ones with a value of 1 turn into 4, and the ones with a value of 4 turn into 1 and scoring is done. The score obtained in the total of both scales takes minimum 20 and maximum 80 values. A high total score indicates an increase in anxiety level, while a low score indicates a decrease in anxiety level . A total score above 60 points indicates that the individual needs professional support.
0-40 points: No anxiety 41-60 points: Mild anxiety 61>points: Severe anxiety. Annex-4 Informed Consent Form The consent form was prepared by the researcher and the consent of the intervention and control groups will be obtained separately.
- Conditions
- Breast Feeding, Anxiety, Motivational Interviews
- Being tested
- Motivational interview techniques
- Keywords
- breastfeeding, motivational interviewing, anxiety
- Medical subject headings
- Breast Feeding, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interview techniquesBehavioural
Motivational interviews will be conducted 4 times. As a result of these interviews, the breastfeeding problem or anxiety in the mother will be evaluated and the effectiveness of the interview will be solved.
| Study group | Role | What they receive |
|---|---|---|
| arm1 | No intervention | Will receive standard breastfeeding training and after 3 weeks the final test will be administered |
| arm2 | Experimental | A motivational interview will be conducted to get information about the breastfeeding problem and the level of loss and to try to support it with interviews. Receives: Behavioral: Motivational interview techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of motivational interviewing on breastfeeding
Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.
Measured: three weeks from the start of the interview
The effect of motivational interviewing on anxiety
Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.
Measured: three weeks from the start of the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Sep 2024
- Primary completion27 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- breastfeeding problems anxiety motivational interviewing
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- semiha izgordu
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor-investigator, semiha izgordu, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713109
- Sponsor's protocol ID
- 6135142-020-143
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: kimlerle paylaşılacağından emin değilim
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivasyonel Görüşme Il Verilen Emzirme Danışmanlığının Emzirme Sorunu Ve Kaygıya Etkisi
- ClinicalTrials.gov ID
- NCT06713109
- Acronym / sponsor ID
- 6135142-020-143
- Conditions
- Breast Feeding, Anxiety, Motivational Interviews
- Keywords
- breastfeeding, motivational interviewing, anxiety
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- semiha izgorduUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 3 Dec 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.
The primary aim of this study was to investigate the effect of motivational interviewing technique on breastfeeding problems and loss.
H1:The breastfeeding problems score of the mothers who received motivational interviewing was lower than the mothers who received standard care.
H 2: The anxiety level score of mothers who received motivational interviewing is lower than that of mothers who received standard care.
H3: The rate of exclusive breastfeeding of mothers who received motivational interviewing is higher than that of mothers who received standard care.
Detailed description
The data elements to be used in the study are as follows:
'Personal Information Form (Appendix-1)', "Breastfeeding Problems Assessment Scale (Appendix-2)" to determine the problems experienced by mothers regarding breastfeeding, and "State Anxiety Scale (Appendix-3)" to determine the anxiety level of mothers will be used to collect the data. 'Informed Consent Form (Appendix-4)' will be filled in and permission to participate in the study will be obtained.
Appendix 1- Personal Information Form A personal information form was prepared by reviewing the literature (Gölbaşı et al.) The information form questioning the socio-demographic, obstetric and breastfeeding characteristics of the mothers was prepared by the researcher and consisted of 19 items in total.
Appendix-2 Breastfeeding Problems Assessment Scale (BPSAS) Originally named 'Breastfeeding Experience Scale', the ESBS was developed by Karen Wambach in 1990 to evaluate mothers' breastfeeding experiences . The Turkish validity and reliability of the scale was conducted in 2019 . The original scale has a 5-point Likert type and consists of 5 sub-dimensions and 30 items. The scale consists of two parts. The first part consists of 18 items and evaluates breastfeeding problems. The second part consists of items 19-30 and assesses mothers' weaning experiences and formula supplementation practices. The Turkish version of the scale includes only the first part and consists of 18 items and 5 sub-dimensions. The 5 sub-dimensions of the scale (mechanical concerns; 16, 6, 4, 11, 14, process concerns; 12, 9, 8, 5, 3, milk insufficiency concerns; 13, 15, 10, breast concerns; 2, 1, 7, social concerns; 18, 17) were determined by confirmatory factor analysis. Scale items are graded as 1; not at all, 2; mild, 3; moderate, 4; severe, 5; unbearable. Each item is scored between 1 and 5. The minimum and maximum scores that can be obtained from the scale are 18-90. High scores obtained from the scale indicate that breastfeeding problems are severe. Cronbach's alpha coefficient for the evaluation of the reliability of the 18 items in the Breastfeeding Problems Assessment Scale was found to be 0.776. Cronbach's alpha values of the scale sub-dimensions; mechanical concerns; 0.852, process concerns; 0.712, milk insufficiency concerns; 0.766, breast concerns; 0.748, social concerns; 0.789 were found. It was found that there was no difference between the test-retest measurements of the scale and its invariance over time was determined. It was determined that the Breastfeeding Problems Assessment Scale is an appropriate measurement tool for assessing the problems of breastfeeding mothers in Turkish society.
Appendix 3- State Anxiety Inventory (STAI State Anxiety Inventory) State Anxiety Scale is a self-assessment questionnaire consisting of short statements. The State Anxiety Scale requires the individual to describe how he/she feels at a certain moment and under certain conditions and to answer by taking into account his/her feelings about the situation he/she is in. It consists of 20 questions in total.
The feelings or behaviours expressed in the items of the state anxiety scale consist of 1) not at all, 2) a little, 3) a lot and 4) completely according to the severity of the experience. Developed in 1964 by Spielber-ger and Gorsuch, the inventory aims to measure trait and state anxiety levels in normal and non-normal individuals.
After the adaptation and standardisation of the scale into Turkish by Öner and Le Compte in 1974-1977, the inventory was used in studies involving Turkish youth and adult groups.
There are two types of statements in the scale. These can be called (1) direct or straight statements and (2) re-verse statements. Direct statements express negative emotions, whereas reversed statements express positive emotions. When scoring these second type of statements, those with a weight value of 1 are converted to 4 and those with a weight value of 4 are converted to 1. In direct statements, answers with a value of 4 indicate that anxiety is high. In inverted statements, answers with a value of 1 indicate high anxiety and answers with a value of 4 indicate low anxiety. The expression 'I am restless' can be shown as an example of direct statements and the expression 'I feel calm' can be shown as an example of inverted statements. In this case, if an option with a weight of 4 is selected for the expression 'I feel restless' and an option with a weight of 1 is selected for the expression 'I feel calm', these answers reflect high anxiety. There are ten inverted statements in the state anxiety scale. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20.
In the reversed statements, the ones with a value of 1 turn into 4, and the ones with a value of 4 turn into 1 and scoring is done. The score obtained in the total of both scales takes minimum 20 and maximum 80 values. A high total score indicates an increase in anxiety level, while a low score indicates a decrease in anxiety level . A total score above 60 points indicates that the individual needs professional support.
0-40 points: No anxiety 41-60 points: Mild anxiety 61>points: Severe anxiety. Annex-4 Informed Consent Form The consent form was prepared by the researcher and the consent of the intervention and control groups will be obtained separately.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- breastfeeding problems anxiety motivational interviewing
| Arm | Type | Receives |
|---|---|---|
| arm1 | No intervention | –Will receive standard breastfeeding training and after 3 weeks the final test will be administered |
| arm2 | Experimental | Behavioral: Motivational interview techniquesA motivational interview will be conducted to get information about the breastfeeding problem and the level of loss and to try to support it with interviews. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Having a healthy 1-3 month old baby
- Being identified as having a breastfeeding problem
- To be at least primary school graduate
- To be able to communicate by telephone
- To come to the Family Health Centre for motivational talks
Key exclusion criteria (6 listed)
- Having a baby with anomalies
- Having a baby younger than 1 month and older than 3 months
- Having a medical illness that prevents breastfeeding
- Communication problems
- Not accepting motivational interviewing
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 |
|---|---|---|
| Motivational interview techniquesMotivational interviews will be conducted 4 times. As a result of these interviews, the breastfeeding problem or anxiety in the mother will be evaluated and the effectiveness of the interview will be solved. | Behavioural | arm2 |
Primary outcome
The effect of motivational interviewing on breastfeeding
Time frame: three weeks from the start of the interview
Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.
The effect of motivational interviewing on anxiety
Time frame: three weeks from the start of the interview
Breastfeeding Problems Assessment Scale and State Anxiety Inventory scores will be collected and statistical analysis will be performed by spss software and expert statistician opinion will be obtained.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Undecided. kimlerle paylaşılacağından emin değilim
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview techniques in people with Breast Feeding and Anxiety, run by semiha izgordu 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 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: enrolling by invitation, as of the sponsor's last update on 3 Dec 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?
This study is still under way. Results are not available in the source record yet.
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 effect of motivational interviewing on breastfeeding (time frame: three weeks from the start of the interview). The study lists 2 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 3 Dec 2024.