Clinical trial NCT06422780: Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women
Official title: Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women: Randomised Controlled Trial With Postpartum Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Postpartum Complication
Keywords: pregnancy
postpartum period
occupational therapy
quality of life
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised controlled trial with follow-up
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare maternal role preparation and mindfulness-centred occupational therapy trainings in pregnant women: a randomised controlled trial with postpartum follow-up.

Detailed description: Pregnancy and postpartum are a major change and crisis process for women. Women undergo hormonal, vascular, anatomical, physiological, and psychological changes for 40 weeks to meet the biochemical needs of the developing fetus, maintain homeostasis, and prepare for childbirth and lactation. These changes occurring during pregnancy are necessary to protect the health of mother and baby, as well as to prepare women for childbirth and maternity.

Psychological changes that vary from trimester to trimester, accompanied by physiological changes in pregnancy. Especially in the second and third trimester, changes in the biopsychosocial balance, affecting family and work roles, taking on new responsibilities, trying to adapt to new roles and meeting the baby increased perceived depression, anxiety and stress. These physiological and psychological symptoms during pregnancy have been to adversely affect the quality of life of pregnant women. In literature, participation in meaningful and purposeful activities, which is an important indicator of quality of life, is also believed to have an impact on occupational performance during pregnancy. During pregnancy, post-partum and postpartum, the mother is expected to adapt to the physiological and psychological changes she experiences, to be able to take care of herself and her baby, to play the role of mother and to accept her baby. Physical activity levels, sleep and quality of life during pregnancy are also likely to be affected by maternal role adaptation and participation in social life. In this context, it should be taken into account that the period of pregnancy is an important milestone for the end of childbirth and the postpartum period.

Postpartum physical problems occur in 70% of women, while 17% of women are accompanied by emotional problems.Especially in the postpartum period, emotional changes have been to occur in between 24% and 89% of women with post-partum depression (PPD), between 40% and 50% of mothers and between 9% and 30% of female with anxiety. Emotional problems can also arise as a result of a mother's physical problems, such as providing baby care, creating a safe environment for the baby, communicating with the child, learning new roles, developing family sensitivity, and dealing with problems related to the baby. Therefore, the postpartum period can become a crisis life for the family, just like pregnancy.Physical and emotional symptoms may adversely affect family, work, and social life, thereby reducing quality of life. (14,15,24). Physical and emotional symptoms have also been to negatively affect the maternal bond between the mother and the baby, the mother's sense of self, occupational balance, and occupational performance.

Occupational Theraphy is a health care profession that supports an individual's ability to sustain occupational performance through various interventions and person-centric practices, helping the individual to adapt to changes that are constantly encountered within and around him. In this context, one of the interventions used to enhance pregnancy coherence is maternal role preparation training. Maternal role preparation is an occupational training that focuses on improving motherhood competence and living a successful role-to-mother harmony when the mother becomes a mother for the first time.

One of the other interventions used in occupational therapy is a person-centric occupation therapy. In today's occupational therapy interventions, person-centric practices have always been a key element. With a person-centric approach, consultants and therapists work together to identify the nature of their occupational performance problems, the focus and need of the intervention, and the consequences of the preferred treatment.

In this context, the study was planned to study tangible behavioral changes resulting from interventions in healthy pregnant women and their impact on participation in daily life activities. Our study aims to study the effectiveness of maternal role preparation training and awareness-based occupational therapy and post-partum follow-up.

This study is important for the continuation of valuable activities and roles within pregnant women's daily routines, for the development of new strategies to make them feel better during pregnancy, and for a clinically integrated approach.

Eligibility criteria: Inclusion criteria for pregnant women:

* 18 to 35 years of age
* Having conceived naturally
* Being between 14-27 weeks of gestation
* To be literate
* Being primiparous
* Reading and understanding Turkish
* Volunteering to participate in the study
* To have attended 80% of the trainings given

Inclusion criteria for women in the postpartum period:

* Giving birth at term
* Having a healthy newborn (newborn born at 38-42 weeks of gestation, without low birth weight, without any disease)
* Providing active care to the newborn baby with or without assistance

Exclusion criteria for pregnant women

* Having a risky pregnancy (gestational diabetes, eclampsia, pre-eclampsia, threatened preterm birth, premature rupture of membranes, placental anomalies etc.)
* Having a maternal physical anomaly
* Communication difficulties and mental deficiency
* Having a medical history of mental illness
* Having a foetal abnormality during pregnancy
* Having a disease/complication that developed during pregnancy

Exclusion criteria for women in the postpartum period:

* Experiencing a traumatic event within 6-8 weeks postpartum (loss/death of a close person, natural disasters, accident, assault)
* Stillbirth or having a baby with anomalies
* Having a baby that requires an intensive care environment in a hospital
* Mothers diagnosed with psychiatric illness (schizophrenia, depression, anxiety, panic attacks)

Primary outcomes:
measure: Nothingham Health Profile(NHP)
timeFrame: 3 weeks
Secondary outcomes:
measure: Demographic Data Form
timeFrame: 1 weeks
measure: Occupational Balance Questionnaire(OBQ11-T)
timeFrame: 3 weeks
measure: Time Management Questionnaire(TMQ)
timeFrame: 3 weeks
measure: The Hospital Anxiety and Depression Scale(HADS)
timeFrame: 3 weeks
measure: The Cognitive Emotion Regulation Questionnaire
timeFrame: 3 weeks
measure: Coping Style Scales
timeFrame: 3 weeks
measure: Visual Pain Scale(VPS)
timeFrame: 3 weeks
measure: Visual Sleep Scale(VSS)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Çankırı Karatekin University Occupational Therapy Department
Study officials:
References: