- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06628986
MBSR og NLP, Postpartum Amning og Depression (postpartum)
effekten af MBSR- og NLP-applikationer på træthed, søvnkvalitet, amning og fødselsdepression i postpartumperioden efter kejsersnit
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Eyalet/Yerleşke
-
Sanliurfa, Eyalet/Yerleşke, Tyrkiet (Türkiye), 63000
- Şanlıurfa training and research hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Exclusion Criteria:
- women who refused to participate in the research.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mindfulness-based stress reduction program
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. |
20 minutes once a week for 8 weeks
Andre navne:
|
|
Eksperimentel: Neurolinguistic programming
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. |
NLP Neurolinguistic programming, 20 minutes once a week for 8 weeks
Andre navne:
|
|
Eksperimentel: control
control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
control group, no practice,
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale for Fatigue (VAS-F)
Tidsramme: 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. |
before the first application
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Tidsramme: Week 4, following the intervention administered on that day
|
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, following the intervention administered on that day
|
|
Visual Analogue Scale for Fatigue (VAS-F)
Tidsramme: Week 8, following the final intervention
|
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, following the final intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 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. |
before the first application
|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: week 4, following the intervention administered on that day
|
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, following the intervention administered on that day
|
|
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: week 8, , following the final intervention
|
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, , following the final intervention
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Tidsramme: 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. |
before the first application
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Tidsramme: week 4, following the intervention administered on that day
|
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, following the intervention administered on that day
|
|
Edinburgh Postpartum Depression Scale (EPDS)
Tidsramme: week 8, following the final intervention
|
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, following the final intervention
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Tidsramme: 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. |
before the first application
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Tidsramme: week 4, following the intervention administered on that day
|
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, following the intervention administered on that day
|
|
Breastfeeding Self-Efficacy Scale (BSES)
Tidsramme: week 8, following the final intervention
|
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, following the final intervention
|
|
Exclusive breastfeeding status
Tidsramme: before the first application
|
Exclusive breastfeeding status (yes or no) |
before the first application
|
|
Exclusive breastfeeding status
Tidsramme: week 4, following the intervention administered on that day
|
Exclusive breastfeeding status (yes or no) |
week 4, following the intervention administered on that day
|
|
Exclusive breastfeeding status
Tidsramme: week 8, following the final intervention
|
Exclusive breastfeeding status (yes or no) |
week 8, following the final intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: AYŞEGÜL KILIÇLI, Dr., Muş Alparslan University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Psykiske lidelser
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Graviditetskomplikationer
- Stemningsforstyrrelser
- Puerperale lidelser
- Depressiv lidelse
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Fodringsadfærd
- Træthed
- Depression, postpartum
- Amning
- Undersøgelsesteknikker
- Epidemiologisk forskningsdesign
- Epidemiologiske metoder
- Forskningsdesign
- Metoder
- Kontrolgrupper
Andre undersøgelses-id-numre
- Mauniv
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
All
IPD-delingstidsramme
8 October 2024 - 30 October 2025
IPD-delingsadgangskriterier
8 October 2024 - 30 October 2025
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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