The Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic

November 22, 2021 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Sağlık Bilimleri Üniversitesi
        • Contact:
      • İstanbul, Turkey, 34668
        • Recruiting
        • Zeynep Kamil Women's and Children's Diseases Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The mothers in this group will be given telehealth training for 4 weeks.
Behavioral: Experimental
education group
No Intervention: Control
Mothers in this group will not be given telehealth education, they will receive care within the scope of routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postpartum depression
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2021

Primary Completion (Anticipated)

November 22, 2021

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.04.2021-27076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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