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NCT Number: NCT06628986

MBSR and NLP, Postpartum Breastfeeding and Depression

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.

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Key information

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Şanlıurfa training and research hospital

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

Location status: Recruiting

Location contact

AYŞEGÜL KILIÇLI

CONTACT

[email protected]

04143186000

About this study

The postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. Studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. As important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. However, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation.

When the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19-35 years old
  • caesarean section
  • primiparous
  • breastfeeding women

Exclusion criteria

  • women who refused to participate in the research.

Treatment and study plan

MBSR

Behavioral

20 minutes once a week for 8 weeks

Other names: MBSR mindfulness-based stress reduction program

NLP

Behavioral

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

Other names: NLP Neurolinguistic programming

Control

Behavioral

control group, no practice,

Other names: control group

Primary outcomes

  1. Visual Analogue Scale for Fatigue (VAS-F)

    Time frame: before the first application

    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.

  2. Visual Analogue Scale for Fatigue (VAS-F)

    Time frame: Week 4

    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.

  3. Visual Analogue Scale for Fatigue (VAS-F)

    Time frame: Week 8

    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.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: before the first application

    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.

  5. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: week 4

    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.

  6. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: week 8

    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.

  7. Bristol Breastfeeding Assessment Tool (BBAT)

    Time frame: before the first application

    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.

  8. Bristol Breastfeeding Assessment Tool (BBAT)

    Time frame: week 4

    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.

  9. Bristol Breastfeeding Assessment Tool (BBAT)

    Time frame: week 8

    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.

  10. Edinburgh Postpartum Depression Scale (EPDS)

    Time frame: before the first application

    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.

  11. Edinburgh Postpartum Depression Scale (EPDS)

    Time frame: week 4

    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.

  12. Edinburgh Postpartum Depression Scale (EPDS)

    Time frame: week 8

    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.

  13. Breastfeeding Self-Efficacy Scale (BSES)

    Time frame: before the first application

    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.

  14. Breastfeeding Self-Efficacy Scale (BSES)

    Time frame: week 4

    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.

  15. Breastfeeding Self-Efficacy Scale (BSES)

    Time frame: week 8

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

AYŞEGÜL KILIÇLI, Dr.

CONTACT

[email protected]

04143181717

AYŞEGÜL KILIÇLI, PhD.

CONTACT

[email protected]

04143180000

Sponsors and collaborators

Lead sponsor

Aysegul Kilicli

Other

Registry information

Official study title

the Effect of MBSR and NLP Applications on Fatigue, Sleep Quality, Lactation and Postpartum Depression in the Postpartum Period After Caesarean Section

Acronym: postpartum

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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