NCT04847362

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

April 12, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

postpartum depressionmother-baby attachmentanxiety

Outcome Measures

Primary Outcomes (6)

  • postpartum depression

    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

    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

    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

    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

    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

    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

Study Arms (2)

Experimental

EXPERIMENTAL

The mothers in this group will be given telehealth training for 4 weeks.

Behavioral: Experimental

Control

NO INTERVENTION

Mothers in this group will not be given telehealth education, they will receive care within the scope of routine care.

Interventions

ExperimentalBEHAVIORAL

education group

Experimental

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • women who do not meet the sample selection criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zeynep Kamil Women's and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depression, PostpartumAnxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 19, 2021

Study Start

April 11, 2021

Primary Completion

November 22, 2021

Study Completion

January 30, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations