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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

Tracking Information
First Submitted Date  ICMJE April 12, 2021
First Posted Date  ICMJE April 19, 2021
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE April 11, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2021)
  • 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 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 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 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.
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2021)
  • postpartum depression [ Time Frame: postpartum 6 weeks ]
    Edinburgh Postpartum Depression Scale
  • postpartum depression [ Time Frame: postpartum 3 months ]
    Edinburgh Postpartum Depression Scale
  • postpartum mother-baby attachment [ Time Frame: postpartum 6 weeks a ]
    Postpartum Attachment Scale
  • postpartum mother-baby attachment [ Time Frame: postpartum 3 months ]
    Postpartum Attachment Scale
  • anxiety state [ Time Frame: postpartum 6 weeks ]
    State and Trait Anxiety Scale
  • anxiety state [ Time Frame: postpartum 3 months ]
    State and Trait Anxiety Scale
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tele-Health Education Provided in the Postpartum Period in the Covid 19 Pandemic
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Postpartum Depression
  • Anxiety State
Intervention  ICMJE Behavioral: Experimental
education group
Study Arms  ICMJE
  • Experimental: Experimental
    The mothers in this group will be given telehealth training for 4 weeks.
    Intervention: Behavioral: Experimental
  • No Intervention: Control
    Mothers in this group will not be given telehealth education, they will receive care within the scope of routine care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2021)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04847362
Other Study ID Numbers  ICMJE 11.04.2021-27076
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
Study Sponsor  ICMJE Saglik Bilimleri Universitesi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Saglik Bilimleri Universitesi
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP