Clinical trial NCT06787300: Stories That Empower Mothers and Postpartum Depression
Official title: The Effect of Stories to Empower Mothers Programme on Postpartum Depression in Primigravid Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum depression
pschiatric nursing
promotion of mental health
nursing intervention
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-01-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is conducted in a non-randomised experimental follow-up research design.
Primary purpose: PREVENTION

Brief summary: Postpartum depression is a condition that occurs after birth and is difficult for mothers. Research shows that experiencing postpartum depression once increases the risk of experiencing it in subsequent pregnancies. At the same time, there are findings in the literature that pregnant women with postpartum depression experience mental difficulties, anxiety or depression during pregnancy. For this reason, this study aims to determine the risk of postpartum depression in pregnant women who are pregnant for the first time during pregnancy and to prevent this risk from occurring in the postpartum period. For this purpose, 'Stories to empower mothers' programme was created. This programme was created by researchers who are specialist psychiatric nurses, psychotherapists and art therapists and finalised with expert opinions. The programme consists of six sessions. The sessions are individual and are conducted online except for the first session. A storybook is formed at the end of the programme with the steps followed during the sessions. While creating this storybook, the themes of self-knowledge, defining the situation, identifying difficulties, identifying sources of help, discovering strengths and creating new coping strategies are addressed by using art therapy techniques. The aim of the study is to examine the effect of the 'Stories Empowering Mothers Programme' on the risk of postpartum depression in pregnant women experiencing their first pregnancy.

The research is conducted in a non-randomised experimental follow-up research design. Pregnant women who meet the inclusion criteria of the study can be included in the experimental or control group according to their wishes. The data collection process in the study proceeds in the order of determining the target group, pre-test (24-32nd gestational week), post-test (after 5 weeks), follow-up one test (postpartum 2nd-4th week) and follow-up two tests (postpartum 10th-12th week). The data are obtained with the Case Report Form and Postpartum Information Form prepared by the researcher and EPDI, BDI and Brief Psychological Resilience Scale forms.

Expert support will be obtained for statistical analyses. Ethics committee permission was obtained before the research was started to be conducted. The research is a doctoral thesis supported by TÜBİTAK.

Detailed description: Within the scope of this research, it is aimed to develop the 'Stories that Empower Mothers' programme, which can evaluate the mental health of women from the pregnancy process, based on the basic skills and philosophy of psychiatric nursing, using the therapeutic power of art, and to evaluate the effect of this programme developed within the scope of this doctoral thesis on the risk of postpartum depression and psychological resilience of pregnant women.

The research is a quantitative, non-randomised experimental follow-up study with intervention and control groups. The research was conducted in a pretest, posttest and two follow-up tests for both intervention and control groups.

The population of the study consisted of primigravid women who applied to Ege University Hospital Gynaecology and Obstetrics outpatient clinic. The number of pregnant women applying to Ege University Gynaecology and Obstetrics outpatient clinic is about 60 per day, but it is not known how many of the applications are first pregnancies. The sample selection method was not used in the study, and all pregnant women who met the criteria for inclusion in the study within the specified time interval were included in the experimental or control group according to their preferences. In order to determine the sample size, the power analysis of the study was calculated with the G\*Power 3.1.9.7 programme. For the two groups, it was found appropriate to work with a total of 24 people with 80% power and 0.05 error, taking the effect size at a moderate level (f = 0.25). It was planned to study with a total of 30 patients (15 people in each group).

Dependent Variables In the study, women's descriptive characteristics, postnatal evaluations, Beck Depression Scale, Edinburg Postnatal Depression Scale and Psychological Resilience Scale for Adults score levels constitute the dependent variables.

Independent Variables Stories that empower mothers programme is the independent variable. The research data are obtained with the Case Report Form and Postnatal Information Form prepared by the researcher, and EPBS, BDI and Brief Psychological Resilience Scale. Permission for the scales was obtained from the authors via e-mail.

The Stories That Empower Mothers program is planned as a nursing experimental program using art therapy techniques prepared by the researcher. The aim of the program is to reduce the risk of depression in the postpartum period by increasing the psychological resilience of pregnant women whose postpartum depression risks are determined. While structuring the program, it was created by evaluating the sub-concepts of psychological resilience and art therapy techniques within the scope of the psychiatric nursing philosophy and the care standards of the psychiatric nurse. Among the studies examined, it is seen that different branches of art are used in the emotional state of pregnant women and postpartum depression, and it is recommended to use the therapeutic function of art. The program utilizes visual art activities such as imagery, painting, and story writing techniques. The program flow begins with introductions, introducing the program to the pregnant woman, and explaining the program and session goals. It is completed with the discovery of the pregnant women about themselves, their feelings about becoming a mother, their coping mechanisms, their strengths, and their support mechanisms, and the creation of a storybook product from this discovery journey. The general flow of the sessions progresses with the stages of warming up, implementing the application determined for the session, summarizing the session, and planning the next session. After the program was created, it was presented to expert opinion before implementation.

It is seen that the program sessions implemented within the scope of the literature are organized between 6 and 8 weeks .The Stories That Empower Mothers Program coincides with the beginning of the third trimester of pregnant women and is planned as six sessions. The first of the sessions will be held face-to-face with the women in a clinical environment with a pre-test. The other five sessions will be conducted online. Within the scope of the program, visual art materials such as paper, pencil, glue, paint, scissors are used to support the creativity of the pregnant women. The art products are then provided by the researcher, and an additional list of suggestions is provided to the pregnant women in case they want to enrich the session. At the beginning of each session, light music is used in warm-up activities to support the pregnant women to focus on the here and now. The Stories That Empower Mothers Program is carried out through an online and free video call program (Skype). How to set up and use the program is explained to the pregnant women with a visual. No video or audio recordings are made in the program, and this information is explained to the pregnant women at the beginning of each session. The pregnant women are also asked to create an environment that will not interfere with the interview and where they can ensure their own privacy during the interview. At the same time, at the beginning of the session, the researcher shows the pregnant woman the room she is in, indicating that she ensures her privacy. The researcher keeps a report containing her observations about the continuity of the process and the individuals' conditions during and after the sessions, but these reports are not included in the data of the study. At the end of the sessions, the pregnant women are asked to photograph the art products they have created and send them to the researcher. Pregnant women are informed that these photographs will only be used within the thesis and will not be shared in any other virtual environment.

Eligibility criteria: Inclusion Criteria:

* First pregnancy,
* Singleton pregnancy,
* Gestational week between 24-32,
* Regular doctor follow-up,
* Scored ≥ 10 on the EDBS,
* Scored \< 17 on the BDI,
* Literate,
* No disability in sensory organs that would prevent communication,
* Owning a smart phone or computer,
* Having internet access,
* Volunteering

Exclusion Criteria:

* Being in the first trimester of pregnancy,

  * Being treated/therapized with any psychiatric diagnosis,
  * Having a risky pregnancy,
  * Being at risk of premature birth and developing it,
  * Having any complications related to pregnancy (gestational diabetes, hypertension, bleeding, etc.),
  * The baby is not healthy,
  * Developing complications during and after birth,
  * The baby needs intensive care after birth,
  * Having a baby lost,
  * Having a premature birth (\<37 weeks),
  * The mother has experienced serious daily life difficulties (disaster, loss, etc.),
  * Not attending three or more of the six sessions

Primary outcomes:
measure: Case Report Form
timeFrame: 24 - 32. gestational week
measure: Edinburgh postpartum depression scale
timeFrame: pre-test( 24 - 32. gestational week), post-test( (30 to 38 weeks of gestation, 6 weeks after the pretest) , follow-up 1 test, (2 - 4. postnatal week), follow-up 2 test (10 -12. postanal week)
measure: Beck Depression Inventory
timeFrame: pre- test( 24 - 32. gestational week),
measure: Brief Resilience Scale
timeFrame: pre-test( 24 - 32. gestational week), post-test(30 to 38 weeks of gestation, 6 weeks after the pretest)
measure: Postpartum Information Form
timeFrame: Follow-up 1 test, (2 - 4. postnatal week)
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References:
citation: Perkins R, Yorke S, Fancourt D. How group singing facilitates recovery from the symptoms of postnatal depression: a comparative qualitative study. BMC Psychol. 2018 Aug 17;6(1):41. doi: 10.1186/s40359-018-0253-0.
citation: Demecs IP, Fenwick J, Gamble J. Women's experiences of attending a creative arts program during their pregnancy. Women Birth. 2011 Sep;24(3):112-21. doi: 10.1016/j.wombi.2010.08.004. Epub 2010 Sep 24.
citation: Crane T, Buultjens M, Fenner P. Art-based interventions during pregnancy to support women's wellbeing: An integrative review. Women Birth. 2021 Jul;34(4):325-334. doi: 10.1016/j.wombi.2020.08.009. Epub 2020 Sep 8.