- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04847362
The Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic
22 november 2021 uppdaterad av: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
Investigation of the Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic on the Depression, Attachment and Anxiety Levels of Women: A Randomized Controlled Study
In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
In the planned study, it was aimed to examine the effect of tele-education offered in the postpartum period in the covid 19 pandemic on the levels of depression, attachment and anxiety of women.
Studietyp
Interventionell
Inskrivning (Förväntat)
74
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Istanbul, Kalkon
- Rekrytering
- Sağlık Bilimleri Üniversitesi
-
Kontakt:
- YASEMİN AYDIN KARTAL
- Telefonnummer: +90 5432870029
- E-post: yasemin.aydin@sbu.edu.tr
-
İstanbul, Kalkon, 34668
- Rekrytering
- Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
-
Kontakt:
- LEYLA KAYA
- Telefonnummer: +90 5456439482
- E-post: leylakaya02@hotmail.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
inclusion Criteria
- literate
- Giving birth at term (between 38-42 weeks of gestation)
- Being on the 7th Postpartum Day,
- Participation in the study is voluntary,
- Absence of any psychiatric illness,
- Women who have characteristics such as not using any psychiatric medication.
- Baby with normal birth weight and APGAR score of 8 and above
- Those who have not developed postpartum complications
- Speaks and understands Turkish
Exclusion Criteria:
women who do not meet the sample selection criteria
-
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental
The mothers in this group will be given telehealth training for 4 weeks.
|
education group
|
|
Inget ingripande: Control
Mothers in this group will not be given telehealth education, they will receive care within the scope of routine care.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
postpartum depression
Tidsram: postpartum 6 weeks
|
The Edinburgh Postnatal Depression Scale (EPDS) was used to detect depressive symptoms during the postpartum period [30].
EPDS is a 10-item questionnaire assessing the interviewee's depressive feelings from the seven days before the interview.
The response of the questions is scored from 0-3, with higher scores indicating higher levels of depressive symptoms.
The total EPDS score of a respondentcan range from 0 to 30.
|
postpartum 6 weeks
|
|
postpartum depression
Tidsram: postpartum 3 months
|
The Edinburgh Postnatal Depression Scale (EPDS) was used to detect depressive symptoms during the postpartum period [30].
EPDS is a 10-item questionnaire assessing the interviewee's depressive feelings from the seven days before the interview.
The response of the questions is scored from 0-3, with higher scores indicating higher levels of depressive symptoms.
The total EPDS score of a respondentcan range from 0 to 30.
|
postpartum 3 months
|
|
postpartum mother-baby attachment
Tidsram: postpartum 6 weeks a
|
Postpartum Attachment Scale: Early diagnosis of problems in mother-infant relationship Developed to provide and maternal filling4.
The scale is a six-digit It has a Likert scale.
Scale "always", Postpartum attachment scales in mothers 247 "Very often", "often", "sometimes", "rarely", "no It has been defined as "time".
Items 0-5 It is rated as.
Scale 17 is reverse It consists of 25 graded items.
Scale "attachment disorder" (12 items), "Rejection and irritability" (seven items), "care tension about "(four items), abuse four sub-categories with risk (two substances) It consists of units.
Pathology in mother-infant relationship cut point specified for four subscales 4'18 The cut-off point of four subscales attachment disorder (subscale 1), respectively> 12, rejection and irritability (subscale 2)> 17, anxiety in infant care (subscale 3)> 10, the risk of abuse (subscale 4) is> 3.
|
postpartum 6 weeks a
|
|
postpartum mother-baby attachment
Tidsram: postpartum 3 months
|
Postpartum Attachment Scale: Early diagnosis of problems in mother-infant relationship Developed to provide and maternal filling4.
The scale is a six-digit It has a Likert scale.
Scale "always", Postpartum attachment scales in mothers 247 "Very often", "often", "sometimes", "rarely", "no It has been defined as "time".
Items 0-5 It is rated as.
Scale 17 is reverse It consists of 25 graded items.
Scale "attachment disorder" (12 items), "Rejection and irritability" (seven items), "care tension about "(four items), abuse four sub-categories with risk (two substances) It consists of units.
Pathology in mother-infant relationship cut point specified for four subscales 4'18 The cut-off point of four subscales attachment disorder (subscale 1), respectively> 12, rejection and irritability (subscale 2)> 17, anxiety in infant care (subscale 3)> 10, the risk of abuse (subscale 4) is> 3.
|
postpartum 3 months
|
|
anxiety state
Tidsram: postpartum 6 weeks
|
State Anxiety Scale (STAI-I) in 1970 Turkish form developed by Spielberger Oner N et al.
Its validity and reliability study has been carried out by adapting it.
Anxiety level In STAI-I, "(1) not at all, (2) a little, (3) a lot and (4) completely" While it is scored as, the options in STAI-II are (1) almost never, (2) sometimes, (3) a lot of time, and (4) it is almost always.
2 kinds of scales Scores obtained from both scales theoretically it ranges from 20 to 80. High score indicates high anxiety level
|
postpartum 6 weeks
|
|
anxiety state
Tidsram: postpartum 3 months
|
State Anxiety Scale (STAI-I) in 1970 Turkish form developed by Spielberger Oner N et al.
Its validity and reliability study has been carried out by adapting it.
Anxiety level In STAI-I, "(1) not at all, (2) a little, (3) a lot and (4) completely" While it is scored as, the options in STAI-II are (1) almost never, (2) sometimes, (3) a lot of time, and (4) it is almost always.
2 kinds of scales Scores obtained from both scales theoretically it ranges from 20 to 80. High score indicates high anxiety level
|
postpartum 3 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 april 2021
Primärt slutförande (Förväntat)
22 november 2021
Avslutad studie (Förväntat)
30 januari 2022
Studieregistreringsdatum
Först inskickad
12 april 2021
Först inskickad som uppfyllde QC-kriterierna
14 april 2021
Första postat (Faktisk)
19 april 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Beteendesymtom
- Mentala störningar
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Humörstörningar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Graviditetskomplikationer
- Puerperala störningar
- Depression
- Depressiv sjukdom
- Covid-19
- Ångeststörningar
- Depression, postpartum
Andra studie-ID-nummer
- 11.04.2021-27076
Plan för individuella deltagardata (IPD)
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