Comparison of Maternal Role Preparation and Awareness-Centred Occupational Therapy Trainings in Pregnant Women

NCT06422780 | Completed

• 1 other identifier: HÜ-ERG-AK-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Postpartum Complication

Keywords

pregnancy; postpartum period; occupational therapy; quality of life

Outcome Measures

Primary Outcomes (1)

• Nothingham Health Profile(NHP)

  The Nottingham Health Profile will be used to assess the awareness of pregnant women about their own health status. The Nottingham Health Profile assesses self-perceived health status and includes subsections on pain, emotional reactions, sleep, social isolation, physical activity and energy. These sub-sections make up the more intensively used section 1, while work life, household chores, social life, home life, sexual life, interests and holidays make up section 2. Each section is scored on a scale of 0-100. In the sections consisting of questions answered yes and no, the highest score can be 0 and the lowest score can be 100 (40,41). Turkish adaptation was performed by Küçükdeveci et al. in 1997.

  3 weeks

Secondary Outcomes (8)

• Demographic Data Form

  1 weeks

• Occupational Balance Questionnaire(OBQ11-T)

  3 weeks

• Time Management Questionnaire(TMQ)

  3 weeks

• The Hospital Anxiety and Depression Scale(HADS)

  3 weeks

• The Cognitive Emotion Regulation Questionnaire

  3 weeks

Study Arms (3)

Maternal Role Preparation Training Group

ACTIVE COMPARATOR

Pregnant women in the second trimester (14-27th week) will be included in the trainings.

Other: Maternal Role Preparation Training

Awareness Centred Occupational Therapy Group

ACTIVE COMPARATOR

Pregnant women in the second trimester (14-27th week) will be included in the trainings.

Other: Awareness Centred Occupational Therapy Group

Control Group

NO INTERVENTION

Pregnant women in the second trimester (14-27th week) will be included in the trainings.

Interventions

Maternal Role Preparation Training OTHER

Maternal Role Preparation Training: Maternal Role Preparation Training (MRHE) is an occupational training programme aimed at increasing the competence of first-time mothers regarding motherhood. In this four-session programme, pregnant women will be provided with written materials, face-to-face talks and practical training covering topics related to their babies (maternal attachment, training on the sensory and developmental abilities of babies) and themselves (training on adopting a new role as a mother).The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions.

Maternal Role Preparation Training Group

Awareness Centred Occupational Therapy Group OTHER

Awareness Centred Occupational Therapy (FME); In FME, areas that affect the occupational performance of pregnant women in their daily lives will be identified and appropriate occupational therapy interventions will be applied. Awareness training on the applications will be given before starting the sessions. The sessions will be applied 2 days a week, each session 1 hour, a total of 8 weeks-16 sessions. Awareness training will be given before starting the sessions.

Awareness Centred Occupational Therapy Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Çankırı Karatekin University Occupational Therapy Department

Çankırı, Çankırı, 18100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomised controlled trial with follow-up

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: May 5, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)