Clinical trial NCT06713109: The Effect of Breastfeeding Counselling with Motivational Inter-viewing Technique on Breastfeeding Problems and Anxiety
Official title: Motivasyonel Görüşme Il Verilen Emzirme Danışmanlığının Emzirme Sorunu Ve Kaygıya Etkisi
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Feeding
Anxiety
Motivational Interviews
Keywords: breastfeeding
motivational interviewing
anxiety
Lead sponsor: Uskudar University
Sponsor class: OTHER
Collaborators: name: Marmara University
First posted: 2024-12-03
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: breastfeeding problems anxiety motivational interviewing
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The effect of motivational interviewing on breastfeeding
timeFrame: three weeks from the start of the interview
measure: The effect of motivational interviewing on anxiety
timeFrame: three weeks from the start of the interview
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara Üniversitesi Pendik Eğitim Aile Sağlığı Merkezi
state: Tuzla
Study officials:
References: