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

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ClinicalTrials.gov Identifier: NCT04847362
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi

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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Anxiety State Behavioral: Experimental Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 11, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847362


Locations
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Turkey
Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Recruiting
İstanbul, Turkey, 34668
Contact: LEYLA KAYA    +90 5456439482    leylakaya02@hotmail.com   
Saglık Bilimleri Universitesi Recruiting
Istanbul, Turkey
Contact: YASEMİN AYDIN KARTAL    +90 5432870029    yasemin.aydin@sbu.edu.tr   
Sponsors and Collaborators
Saglik Bilimleri Universitesi
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Responsible Party: YASEMİN AYDIN KARTAL, ASSOCIATE PROFESSOR, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier: NCT04847362    
Other Study ID Numbers: 11.04.2021-27076
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi:
postpartum depression
mother-baby attachment
anxiety
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications