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Clinical Trials/NCT06628986
NCT06628986RecruitingNot Applicable

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

Aysegul Kilicli1 site in 1 country90 target enrollmentStarted: October 8, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Visual Analogue Scale for Fatigue (VAS-F)

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

double blind

Eligibility Criteria

Ages
19 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •women who refused to participate in the research.

Arms & Interventions

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.

Intervention: MBSR (Behavioral)

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.

Intervention: NLP (Behavioral)

control

Experimental

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

Intervention: control (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Aysegul Kilicli
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Aysegul Kilicli

Gaziantep University Health Sciences Institute, Department of Nursing PhD.

University of Gaziantep

Study Sites (1)

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