CClinicalTrials.gg
CompletedNCT05356026Updated May 2, 2022

Online Postpartum Follow-up on Depression and Postpartum Adaptation

An interventional study of Online postpartum follow-up in Postpartum Depression and Postpartum Adaptation, sponsored by Gazi University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by Gazi University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

Objective: To determine the effect of online postpartum follow-up on depression and postpartum adaptation.

Design: A parallel-randomized-controlled study Setting: During 2021 in Turkey Participants: 52 women in the postpartum period Measurements: Data were collected through the Personal Information Form, the Follow-up Form, the Edinburgh Postpartum Depression Scale (EPDS), and the Postpartum Self-Assessment Scale (PSAS). The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk. The women in the control group received the routine follow-up and care provided by the hospital.

Read the detailed description

The purpose of this study is to determine the effect of online postpartum follow-up on depression and postpartum adaptation.

Methods:

Design:

This study utilized a parallel-randomized-controlled experimental design using single-center, stratified randomization (parity: primiparous-multiparous; mode of delivery: vaginal-cesarean).

Participants:

The target population of the study was women in the postpartum period who gave birth in the gynecology service of a university hospital at Ankara (capital city of Turkey) between 10.03.2021 and 20.08.2021. The sample size was determined using power analysis, which included using the information in a similar study conducted before (Serçekuş and Mete, 2010). Analysis was performed using the G power 3.1 version. The minimum number of participants in each group was determined 26, which was 52 in total (α=0,05, 1- β=0,95). However, considering the rate of loss in the source taken as reference (19.7%), a total of 62 individuals were randomized for the sample. In this regard, the participants were planned to be excluded from the study in cases when the mother or the baby is hospitalized, participants want to leave the study, the data collection tools are not filled in, or the participants cannot be reached for education/consultancy. However, no loss of the sample was experienced after the randomization. Post-hoc analysis conducted using the study findings showed that according to the Edinburgh Postpartum Depression Scale mean scores, the power of the study was high (Power [1-β]: 0.99, Effect Size [Cohen's d]: 1.084), and the number of the sample was adequate.

Reliability and Validity of the Study:

Inclusion criteria were determined to prevent selection bias. Hence, the study included volunteer women who were at least literate, who had a live birth, who were aged 18 and over, who were within the first 48 hours of the postpartum period, and who had technical possibilities to use the zoom application.

The women included in the sample were randomized to prevent any bias in distribution. Stratified randomization was performed for the randomization of the study sample. In this regard, the women were divided into 4 stratified groups in terms of parity (primiparous, multiparous) and mode of delivery (vaginal, cesarean).

  1. st Stratum Group: Women who were primiparous and had a vaginal delivery
  2. nd Stratum Group: Women who were primiparous and had a cesarean section
  3. rd Stratum Group: Women who were multiparous and had a vaginal delivery
  4. th Stratum Group: Women who were multiparous and had a cesarean section. Women were assigned to the stratified groups using simple randomization. Hence, for each stratum, the first pregnant woman was assigned to the experimental or control group by flipping a coin. The second pregnant woman was assigned to the opposite group. This procedure was repeated as the 3rd, 5th, and 7th, etc. every two pregnant women. Randomization was done by the researcher and no blinding was performed.

Pre-tests were filled in and randomization assignments of the women were performed by an independent nurse to prevent assignment bias. Data obtained from the studies that aimed to prevent reporting bias were coded by an independent researcher as A and B and put in the SPSS program, and data analysis was performed by an independent statistician.

Data Collection:

Data were collected through the Personal Information Form, the Follow-up Form, the Edinburgh Postpartum Depression Scale (EPDS), and the Postpartum Self-Assessment Scale (PSAS).

The Personal Information Form: The form was composed of nine multiple-choice questions that collected data about women's socio-demographic characteristics.

The Follow-up form: This form was conducted to determine problems experienced by women during follow-ups as well as their educational needs. The form prepared in line with the T.R. Ministry of Health Postpartum Care Management Guide (2014) is composed of 25 questions. Participating women were asked open and closed-ended questions that collected data to evaluate their sleep condition, amount and color of bleeding, pain, urinary problems, constipation, psychological condition, domestic violence, breastfeeding, breast problems, personal hygiene, blood incompatibility, exercise, medicine support, benefits of breast milk and things to do to increase it, postpartum family planning, newborn care, and emergency cases that could happen in the postpartum period.

The Edinburgh Postpartum Depression Scale (EPDS): The scale developed by Cox et al. (1987) is utilized to determine the risk of depression in the postpartum period and to measure its level and severity. EPDS is a self-report scale that has one sub-scale and 10items rated on a 4-point Likert scale. The scores to be obtained from the scale range between 0 and 30. Turkish adaptation of the EPDS was performed by Aydın et al. (2004). The cut-off point of the scale is 12, and women who have higher scores than the total cut-off point are considered to be in the risk group. Cronbach's alpha value was found to be 0.72 in the reliability-validity analysis of the scale. In this study, Cronbach's alpha value was found 0.823.

The Postpartum Self-Assessment Scale (PSAS): The Postpartum Self-Assessment Scale was developed by Lederman and Weingarten (1981). The scale aims to assess the adaptation of women in the postpartum period to maternity. Turkish reliability and validity of the scale were performed by Taşçı and Mete (2007). The scale has 82 items rated on a 4-point Likert scale and has seven sub-scales with 10 to 13 items in each. These sub-scales are the quality of the relationship between partners, partners' perception of participation in childcare, gratification with the labor experience, satisfaction with life situations and circumstances, confidence in the ability to cope with the tasks of motherhood, satisfaction with motherhood, and infant care, and support for the maternal role from friends and other family members. The scores to be obtained from the scale range between 82 and 328. Lower scores indicate good compatibility in that area. In the Turkish reliability and validity of the scale, Cronbach's alpha value was found 0.87. This study found Cronbach's alpha coefficient as 0.936.

Intervention Women who gave birth in the gynecology service were met face-to-face within the first 24 hours of the postpartum period, informed about the purpose of the study as well as the implementation process, and those who agreed to participate in the study were identified. Then women who met the research criteria were determined.

Pre-tests (EPDS and PSAS) were administered after these women were asked to sign informed consent forms. After randomization was performed by the chief nurse of the clinic, the women's groups (experimental or control) were identified, and women's contact details were received.

Experimental Group:

The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk.

The problems and education topics in the follow-ups were as follows:

  1. st Follow-up: The first follow-up was performed in the 2nd to 5th days of the postpartum period and included the evaluation of the overall condition (sleep, rest, weakness), evaluation of bleeding- lochia, evaluation of urinary problems, evaluation of pain (back, chest, headache, etc.), evaluation of palpitation/shortness of breath, intestinal problems, evaluation of the psychological condition, evaluation of domestic violence, evaluation of maternal and infant relationship, evaluation of breasts/breastfeeding and education (lochia follow-up, perineal care, wound care for those who had a cesarean section, breast milk/breastfeeding, physical activity, emergency cases).
  2. nd Follow-up: The second follow-up was performed in the 13th to 17th days and included the evaluation of the overall condition (sleep, rest, weakness), evaluation of bleeding- lochia, evaluation of urinary problems, evaluation of pain (back, chest, headache, etc.), evaluation of palpitation/shortness of breath, evaluation of intestinal problems, evaluation of the psychological condition, evaluation of domestic violence, evaluation of maternal and infant relationship, evaluation of breasts/breastfeeding and education (frequently encountered problems in the newborn, family planning methods).
  3. rd Follow-up: The third follow-up was performed in the 30th to 42nd days and included the evaluation of the overall condition (sleep, rest, weakness), evaluation of bleeding- lochia, evaluation of urinary problems, evaluation of pain (back, chest, headache, etc.), evaluation of palpitation/shortness of breath, evaluation of intestinal problems, evaluation of the psychological condition, evaluation of domestic violence, evaluation of maternal and infant relationship, and evaluation of breasts/breastfeeding.

The content of the education and recommendations for the common problems were prepared using the expert views of six professionals in obstetrics and gynecology nursing, and the content validity was calculated using the Davis Technique (Uğurlu and Akgün, 2019). Content validity index of the education content was found 0,89. During the follow-ups, the problems experienced by either the women or the infants were initially investigated, and standardized recommendations were made for these problems. All the women were asked the same questions, but individualized education and consultancy were given for the problematic cases in the answers. Then standardized education prepared was given through the Zoom program online, using a PowerPoint presentation. The participants were asked 5 questions at the end of each education to test the comprehensibility. Unclear parts in the answers were explained again, and the talks took about 40-60 minutes. After the first follow-up, all the women were sent the education booklet and videos (techniques for pumping breastmilk and postpartum exercise) prepared by the researcher through emails. One week after the first follow-up (between the 30th and 42nd days of postpartum), participating women were administered the EPDS and PSAS again. The data collection tools were put in the Google Forms as online questionnaires and sent to the participants.

Control Group The women in the control group received the routine follow-up and care provided by the hospital. The women were sent the EPDS and PSAS between the 30th to 42nd days of postpartum through email and asked to fill them in.

Data Analysis:

Data were analyzed using the IBM SPSS version 24.0 package program. The normality distribution of the data was analyzed using the Shapiro-Wilk test. Whether the groups were homogenous in terms of some socio-demographic and obstetric features was analyzed using t-test in independent groups in numeric variables and chi-square test in categorical variables. EPDS and PSAS total mean scores of the experimental and control groups were compared using t-test in independent groups. Statistical significance was accepted at 0.05 (p\<0.05). The effect size was determined by calculating Cohen's d (small-0.2, medium-0.5, and large effect-0.8). The power of the hypotheses was tested based on a minimum 0.80 power level to determine the real effect in experimental studies.

02

Conditions studied

  • Postpartum Depression
  • Postpartum Adaptation

Keywords

  • Postpartum depression
  • postpartum adaptation
  • online follow-up
  • postpartum care
  • nurse
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 62 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

Women those,

  • aged 18 and over
  • at least literate
  • who have given a live birth
  • in the first 48-hour period of the postpartum period
  • who have the technical infrastructure to use the online education application (Zoom)

Exclusion criteria

Exclusion Criteria:

Women those,

  • illiterate
  • those with a high-risk pregnancy diagnosis
  • those who do not want to participate
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Online follow up group

    The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk.

    Other: Online postpartum follow-up

  • No intervention
    Routine follow up group

    The women in the control group received the routine follow-up and care provided by the hospital.

Interventions

  • OtherOnline postpartum follow-up

    The women in the experimental group were administered three follow-ups (education/consultancy) in line with the timing and content in the T.R. Ministry of Health Postpartum Care Management Guide (2014). The follow-ups were performed using the Zoom® program, which enabled video talk.

06

What researchers measure

Primary outcomes

  1. Postpartum depression

    The Edinburgh Postpartum Depression Scale (The scale is a self-report scale that has one sub-scale and 10items rated on a 4-point Likert scale. The scores to be obtained from the scale range between 0 and 30. The cut-off point of the scale is 12, and women who have higher scores than the total cut-off point are considered to be in the risk group.)

    Time frame: 6 weeks (Test 1: first 24 hours of the postpartum period, Test 2: between the 30th and 42nd days of postpartum period)

  2. Postpartum adaptation

    The Postpartum Self-Assessment Scale ((The scale aims to assess the adaptation of women in the postpartum period to maternity. The scale has 82 items rated on a 4-point Likert scale and has seven sub-scales with 10 to 13 items in each. These sub-scales are the quality of the relationship between partners, partners' perception of participation in childcare, gratification with the labor experience, satisfaction with life situations and circumstances, confidence in the ability to cope with the tasks of motherhood, satisfaction with motherhood, and infant care, and support for the maternal role from friends and other family members. The scores to be obtained from the scale range between 82 and 328. Lower scores indicate good compatibility in that area.)

    Time frame: 6 weeks (Test 1: first 24 hours of the postpartum period, Test 2: between the 30th and 42nd days of postpartum period)

07

Study locations

1 site
  • Gazi University
    Ankara, 6450, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05356026
Lead sponsor
Gazi University
Responsible party
Şengül Yaman Sözbir (Assoc. Prof., Gazi University) — Principal investigator
First posted
May 2, 2022
Start date
Mar 10, 2021
Primary completion
Aug 20, 2021
Completion
Sep 28, 2021
Last update
May 2, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion