MBSR and NLP, Postpartum Breastfeeding and Depression

NCT06628986 | Recruiting DMC

• 1 other identifier: Mauniv
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.

Conditions

Breastfeeding, Exclusive; Fatigue; Sleep; Postpartum Depression

Keywords

breastfeeding; fatigue; sleep; postpartum depression

Outcome Measures

Primary Outcomes (15)

• Visual Analogue Scale for Fatigue (VAS-F)

  Visual Analogue Scale for Fatigue (VAS-F), The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.

  before the first application

• Visual Analogue Scale for Fatigue (VAS-F)

  Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.

  Week 4

• Visual Analogue Scale for Fatigue (VAS-F)

  Visual Analogue Scale for Fatigue (VAS-F) The most positive expression of the fatigue sub-dimension is 0 and the most negative expression is 10, the most negative expression of the energy sub-dimension is 0 and the most positive expression is 10.

  Week 8

• Pittsburgh Sleep Quality Index (PSQI)

  Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and \>5 indicates poor sleep.

  before the first application

• Pittsburgh Sleep Quality Index (PSQI)

  Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and \>5 indicates poor sleep.

  week 4

• Pittsburgh Sleep Quality Index (PSQI)

  Pittsburgh Sleep Quality Index (PSQI) Each item is evaluated as 0-3 points and the sum of the 7 subcomponents constitutes the PDQI score. The lowest score of the scale is 0 and the highest score is 21. A total PDQI score of ≤5 indicates good sleep and \>5 indicates poor sleep.

  week 8

• Bristol Breastfeeding Assessment Tool (BBAT)

  Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.

  before the first application

• Bristol Breastfeeding Assessment Tool (BBAT)

  Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.

  week 4

• Bristol Breastfeeding Assessment Tool (BBAT)

  Bristol Breastfeeding Assessment Tool (BBAT) In the scoring of the scale, each item is between 0-2 points. The calculation method is to sum all the scores obtained from the scale items. The lowest score obtained from the scale is 0 and the highest score is 8. The scale does not have a cut-off point. A low score indicates that breastfeeding is not effective and a high score indicates that breastfeeding is effective.

  week 8

• Edinburgh Postpartum Depression Scale (EPDS)

  Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.

  before the first application

• Edinburgh Postpartum Depression Scale (EPDS)

  Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.

  week 4

• Edinburgh Postpartum Depression Scale (EPDS)

  Edinburgh Postpartum Depression Scale (EPDS) The scale is a 4-point Likert-type scale consisting of 10 items. Responses consisting of four options are scored between 0 and 3. A minimum of 0 and a maximum of 30 points can be obtained from the scale. The cut-off point of the scale is 13 points and above for women and 10 points and above for men, and above this point indicates the presence of depression.

  week 8

• Breastfeeding Self-Efficacy Scale (BSES)

  Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.

  before the first application

• Breastfeeding Self-Efficacy Scale (BSES)

  Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.

  week 4

• Breastfeeding Self-Efficacy Scale (BSES)

  Breastfeeding Self-Efficacy Scale (BSES) The scale consists of 14 items, five-point Likert type. The items of the scale are evaluated on a scale from '1=never sure' to 5=always sure'. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.

  week 8

Study Arms (3)

Mindfulness-based stress reduction program

EXPERIMENTAL

MBSR; Mindfulness-based stress reduction program. 8 weeks of practice once a week for 20 minutes each. Mindfulness-based stress reduction practices will be carried out online. Mothers will actively participate.

Behavioral: MBSR

Neurolinguistic programming

EXPERIMENTAL

NLP; Neurolinguistic programming 8 weeks of practice once a week for 20 minutes each. Neurolinguistic programming will be carried out online. Mothers will actively participate.

Behavioral: NLP

control

EXPERIMENTAL

control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week.

Behavioral: control

Interventions

MBSR BEHAVIORAL

20 minutes once a week for 8 weeks

Also known as: MBSR mindfulness-based stress reduction program

Mindfulness-based stress reduction program

NLP BEHAVIORAL

NLP Neurolinguistic programming, 20 minutes once a week for 8 weeks

Also known as: NLP Neurolinguistic programming

Neurolinguistic programming

control BEHAVIORAL

control group, no practice,

Also known as: control group

control

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• caesarean section
• primiparous
• breastfeeding women

You may not qualify if:

• women who refused to participate in the research.

Sponsors & Collaborators

• Aysegul Kilicli: lead

Study Sites (1)

Şanlıurfa training and research hospital

Sanliurfa, Eyalet/Yerleşke, 63000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Fatigue; Depression, Postpartum

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• AYŞEGÜL KILIÇLI, Dr.

  Muş Alparslan University

  STUDY DIRECTOR

Central Study Contacts

AYŞEGÜL KILIÇLI, Dr.

CONTACT

04143181717; aysegul_ay_9@hotmail.com

AYŞEGÜL KILIÇLI, PhD.

CONTACT

04143180000; aysegul_ay_9@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gaziantep University Health Sciences Institute, Department of Nursing PhD.

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: October 8, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 8 October 2024 - 30 October 2025
• Access Criteria: 8 October 2024 - 30 October 2025

Locations

TU (1)