- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06628986
MBSR ja NLP, synnytyksen jälkeinen imetys ja masennus (postpartum)
MBSR- ja NLP-sovellusten vaikutus väsymykseen, unen laatuun, imetykseen ja synnytyksen jälkeiseen masennukseen keisarinleikkauksen jälkeisellä synnytyksen jälkeisellä kaudella
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Eyalet/Yerleşke
-
Sanliurfa, Eyalet/Yerleşke, Turkki (Türkiye), 63000
- Şanlıurfa training and research hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- 19-35 years old
- caesarean section
- primiparous
- breastfeeding women
Exclusion Criteria:
- women who refused to participate in the research.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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
Muut nimet:
|
|
Kokeellinen: 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
Muut nimet:
|
|
Kokeellinen: control
control; MBSR and NLP applications will not be performed. Mothers will be monitored online every week. |
control group, no practice,
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Visual Analogue Scale for Fatigue (VAS-F)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: before the first application
|
Exclusive breastfeeding status (yes or no) |
before the first application
|
|
Exclusive breastfeeding status
Aikaikkuna: 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
Aikaikkuna: week 8, following the final intervention
|
Exclusive breastfeeding status (yes or no) |
week 8, following the final intervention
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: AYŞEGÜL KILIÇLI, Dr., Muş Alparslan University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Mielenterveyshäiriöt
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Raskauden komplikaatiot
- Mielialahäiriöt
- Lapsikauden häiriöt
- Masennushäiriö
- Patologiset tilat, merkit ja oireet
- Käyttäytyminen
- Merkit ja oireet
- Ruokintakäyttäytyminen
- Väsymys
- Masennus, synnytyksen jälkeinen
- Imetys
- Tutkintatekniikat
- Epidemiologinen tutkimussuunnittelu
- Epidemiologiset menetelmät
- Tutkimussuunnittelu
- Menetelmät
- Kontrolliryhmät
Muut tutkimustunnusnumerot
- Mauniv
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
All
IPD-jaon aikakehys
8 October 2024 - 30 October 2025
IPD-jaon käyttöoikeuskriteerit
8 October 2024 - 30 October 2025
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- ANALYTIC_CODE
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
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