NCT07100223

Brief Summary

One of the behavioral intervention programs used to adapt to the changes experienced during pregnancy, birth and postpartum and to maintain a healthy transition to parenthood is Conscious Awareness-Based Practices Conscious awareness is an experiential process in which attention is directed purposefully and consciously to what is happening in the body and mind at that moment, and the content that emerges as a result of these observations is accepted with curiosity, understanding and compassion, without being judged, analyzed, or reacted . Due to their stated effects, these interventions help parents improve their awareness and acceptance of thoughts, feelings, and body sensations, reduce reactivity, avoid disturbing experiences, accept the roles and responsibilities of parenting in a non-judgmental manner, learn to use mechanisms to cope with the stress of parenting, and help themselves and the child. It is important to enable people to show compassion . Awareness-based training can be integrated into birth preparation training as it is a method that can be used to improve birth parameters. Awareness-Based Parenting and Birth Preparation Training applied during the transition to parenthood is important as it will increase the quality of pregnancy, birth and postpartum care, as it will increase competence and adaptation to parenting roles, facilitate the birth process, and ensure maternal and paternal attachment. For all these reasons, this research was planned to investigate the effects of Awareness-Based Parenting and Birth Preparation Training given to couples on maternal-paternal attachment, birth parameters and postpartum adaptation. It is thought that the training that parents receive to be aware of their own body and birth process will make a positive contribution to pregnancy, birth and the postpartum process.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

May 15, 2024

Last Update Submit

July 27, 2025

Conditions

Keywords

ADAPTATIONATTACHMENTMINDFULNESSPARENT

Outcome Measures

Primary Outcomes (1)

  • 1. Mindful Attention Awareness Scale(MAAS) total score to assess change in trait mindfulness

    The MAAS is a 15-item self-report questionnaire developed by Brown \& Ryan (2003) and adapted into Turkish by Özyeşil et al. (2011). It measures the frequency of mindful states in daily life using a 6-point Likert scale (1 = Almost always to 6 = Almost never), with total scores ranging between 15 and 90. Higher scores reflect higher dispositional mindfulness. Unit of Measure: Total Score (15-90)

    [Time Frame: Baseline (pre-intervention) and post-intervention (week 8)]

Secondary Outcomes (2)

  • 2. Wijma Delivery Expectancy Questionnaire (W-DEQ)total score to assess fear of childbirth

    [Time Frame: Baseline (gestational week 28-30) and post-intervention (gestational week 36)

  • 3. Visual Analog Scale (VAS)score to assess perceived labor pain

    [Time Frame: IMMEDIATELY AFTER BIRTH]

Study Arms (2)

INTERVENTION GROUP

EXPERIMENTAL

15 couples who meet the inclusion criteria will be assigned to groups according to the parental randomization list. Awareness-Based Parenting and Birth Preparation Training will be given as group training on Mondays of each week, during the hours when the pregnancy school does not provide training.

Other: EDUCATION

CONTROL GROUP

EXPERIMENTAL

No intervention will be made to the parents in the control group other than the birth preparation training carried out by Kayseri City Hospital.

Other: EDUCATION

Interventions

Assignment to the intervention and control groups will be made by randomization method. Before training is given to the intervention and control groups, Parental Introduction Form, Conscious Awareness Scale, Prenatal Attachment Scale, Prenatal Attachment Scale, Fathers' Fear of Birth Scale, Wijma Birth Expectation/Experience Scale Version A will be applied. After parents attend a 1-week birth preparation training at Kayseri City Hospital Pregnancy School, they will participate in a 9-week Awareness-Based Parenting and Birth Preparation Training. After the training is completed; Conscious Awareness Scale, Prenatal Attachment Scale, Prenatal Attachment Scale, Fathers' Fear of Birth Scale, Wijma Birth Expectation/Experience Scale Version A will be applied. Wijma Birth Expectation/Experience Scale Version B will be administered to mothers on the 1st postpartum day.

CONTROL GROUPINTERVENTION GROUP

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipation of both parents in birth preparation training will be ensured.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being in the 18-35 age group,
  • First pregnancy,
  • week of pregnancy,
  • Those who applied to the Pregnancy Polyclinic between the dates of the research and were accepted to the Pregnancy School training,
  • At least literate education level,
  • People who are open to communication will be included in the study.

You may not qualify if:

  • Those with psychiatric disorders,
  • Pregnant women with pregnancy-related risk factors that may lead to premature birth,
  • Pregnant women with chronic diseases that may lead to the risk of premature birth will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasi̇nan, 38080, Turkey (Türkiye)

Location

Related Publications (1)

  • Meleis, A. I. (2010). Transitions theory: Middle range and situation specific theories in nursing research and practice. Springer publishing company. Muller, M.E. (1994). A questionnaire to measure mother- to- infant attachment, J Nurs Meas, 2(2), 129-41. Onat, G. (2021). Farkındalıkla Emzirme Süt Arttırma ve Doğum. Akademisyen Kitabevi. Özyeşil, Z., Arslan, C., Kesici, Ş., Deniz, M.E. (2011) Bilinçli farkındalık ölçeğini Türkçeye uyarlama çalışması. Eğitim ve Bilim Dergisi, 36(160), 224-35. Pallant, J. (2020). SPSS hayatta kalma kılavuzu: IBM SPSS kullanarak veri analizine yönelik adım adım bir kılavuz . McGraw-hill eğitimi (İngiltere). Pan, W.L., Chang, C.W., Chen, S.M., & Gau, M.L. (2019a). Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood-a randomized control trial. BMC Pregnancy and Childbirth, 19(1), 1-8. doi: 10.1186/s12884-019-2503-4 Prinds, C., Hvidtjørn, D., Skytthe, A. (2016). Danimarkalı ilk kez anne olanlar arasında dua ve meditasyon - bir anket çalışması. BMC Gebelik Doğum 16, 8. https://doi.org/10.1186/s12884-016-0802-6 Schumacher, K. L., Meleis, A. L. (1994). Transitions: A central concept in nursing. Image: The Journal of Nursing Scholarship, 26(2), 119-127 Seyhan A.G. (2023). Birlikte Ebeveynliğe Geçiş Programı'nın (Begep) Birlikte Ebeveynlik Algıları Üzerindeki Etkisi. Yüksek Lisans Tezi, Aydın. Shorey, S., Ang, L., Yin, C. A. (2019). Systematic mixed-studies review on mindfulness-based childbirth education programs and maternal outcomes. Nursing Outlook, 67(6), 696-706. Sluijs, A.M., Wijma, K., Cleiren, M.P., Van Lith, J.M., Wijma, B. (2020). Preferred and actual mode of delivery in relation to fear of childbirth. Journal of Psychosomatic Obstetrics & Gynecology, 1-9. Şatır, D. G., Kavlak, O. (2021). Validity and reliability of Turkish version of "Paternal Antenatal Attachment Questionnaire":"Paternal Antenatal Bağlanma Ölçeği" nin Türkçe versiyonunun geçerlik ve güvenirlik çalışması. Journal of Human Sciences, 18(1), 1-11. Taşçı, K., Samiye, Mete. (2010). Postpartum Kendini Değerlendirme Ölçeğinin Geçerlik Ve Güvenirlik Çalışması. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 10(2), 20-29. Taşkın L. (2020). Doğum ve Kadın Sağlığı Hemşireliği. 16. Baskı, Ankara, Akademi Yayınevi, 157-184. Türk Dil Kurumu (TDK) Sözlükleri.(2023). https://sozluk.gov.tr/ Uçar, E., Beji, D.N.K. (2013) Wijma Doğum Beklentisi/Deneyimi Ölçeği B Versiyonu'nun Geçerlik Ve Güvenirlik Çalışması.Yüksek Lisans Tezi. İstanbul. Van Vreeswijk, M., Broersen, J., Schurink, G. (2014). Mindfulness and Schema Therapy: A Practical Guide. Veringa, I.K., Bruin, E.I., Bardacke, N. (2016). I've changed my mind', Mindfulnessbased childbirth and parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial. BMC Psychiatry, 16, 377. Vieten, C., Astin, J. (2008). Effects of a mindfulness-based intervention during pregnancy on prenatal stres and mood: results of a pilot study. Archives of Womens' Mental Health, 11(1), 67-74. Vreeswijk, M. V., Broersen, J., Schurink, G. (2019). Mindfulness ve Şema Terapi Uygulama Rehberi. İstanbul: Psikonet Yayıncılık. Vural Batık, M., Kalkan, M. (2018). Ebeveyn Adayları İçin Evlilik Okulu Psikolojik Danışman El Kitabı, Anı Yayınları. Wijma, K., Wijma, B., Zar, M. (1998). Psychosomatic aspects of W-DEQ: A new questionnaire for measurement of fear of childbirth, Journal of Psychosomatic Obstetric Gynaecology, 19(4), 84-97 Xiao, X., Loke, A.Y. (2022). Intergenerational co-parenting in the postpartum period: A concept analysis. Midwifery, 107, 103275. Yılmaz, S. D.(2013). Prenatal anne-bebek bağlanması. Hemşirelikte Eğitim ve Araştırma Dergisi, 10(3), 28-33. Young, C., Roberts, R., Ward, L. (2020). Enhancing resilience in the transition to parenthood: a thematic analysis of parents' perspectives. Journal of Reproductive and Infant Psychology, 39(4), 358-370.

    RESULT

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the study, couples will be assigned to groups according to the randomization list.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: An experimental design with pretest posttest control group will be used.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

May 15, 2024

First Posted

August 3, 2025

Study Start

February 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations