NCT07498088

Brief Summary

Pregnancy is a period of comprehensive adaptation for a woman in physiological, psychological, and social terms. During this process, physical and mental transformations occur due to hormonal changes; multifaceted changes emerge, such as adopting the role of motherhood, developing a new sense of identity, and adapting to increased responsibilities. These changes during pregnancy affect not only the mother but also the fetus. Especially from the 26th week of pregnancy onwards, with the development of the fetus's auditory and sensory perception capacity, a process of reciprocal interaction begins between mother and fetus. This early interaction forms the basis of prenatal bonding.Prenatal bonding is a dynamic process involving behaviors such as the mother developing emotional closeness towards the fetus, talking to it, making contact, and preparing for care. This bonding directly affects the post-natal mother-baby relationship. However, prenatal bonding is influenced by many factors such as anxiety, stress, history of psychiatric illness, pregnancy complications, socioeconomic status, social support, and previous pregnancy experiences. Women who have experienced prenatal loss (abortion, stillbirth, neonatal death) frequently experience increased anxiety, stress, and difficulty bonding in subsequent pregnancies. High levels of uncertainty, fear, and anxiety in these individuals can negatively impact both the pregnancy and postpartum periods. The literature indicates that women who have experienced prenatal loss have lower levels of prenatal bonding and increased risks of anxiety and depression compared to those who have had healthy pregnancies. Increased stress and anxiety during the prenatal period have also been shown to be associated with negative outcomes such as low birth weight, premature birth, and neurodevelopmental problems. Therefore, supporting psychological well-being during pregnancy is critically important.In this context, interventions aimed at strengthening the bond between mother and fetus are gaining importance. Haptonomy, as a touch-based approach, is a holistic method that supports the establishment of emotional bonds between mother, father, and fetus. This method aims to develop trust-based communication by prioritizing the physical and emotional acceptance of the individual's presence. In haptonomy practices, the goal is for expectant mothers to first increase their own bodily and emotional awareness, and then to establish a conscious interaction with the fetus. Studies show that haptonomy reduces stress, anxiety, and fear of childbirth in pregnant women, while increasing prenatal bonding levels. It is also reported to have positive effects on newborns, improving their adaptation to environmental stimuli. However, the number of studies on haptonomy is limited, and research is needed, particularly focusing on its effects in pregnant women who have experienced prenatal loss. The aim of this research is to examine the effect of haptonomy on prenatal bonding and anxiety levels in pregnant women who have experienced abortion. It is hypothesized that haptonomy may strengthen mother-fetus bonding by reducing negative emotions experienced during pregnancy after a loss. The findings are expected to contribute to evidence-based care approaches applicable to high-risk pregnancy groups.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress36%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

haptonomyabortionanxietyattachment

Outcome Measures

Primary Outcomes (1)

  • Stirling Antenatal Anxiety Scale

    Developed by Sinesi and colleagues in 2022, the Stirling Antenatal Anxiety Scale is used to assess the level of prenatal anxiety common in pregnant women. This scale is a 5-point Likert type and consists of 9 items. Scale responses are scored as follows: "never" = 0, "rarely" = 1, "sometimes" = 2, "frequently" = 3, "always" = 4. The Cronbach's Alpha coefficient is 0.88 in the original study and 0.87 in the Turkish validity and reliability study. The scale scores range from a minimum of 0 to a maximum of 36 points. A higher score indicates a higher level of anxiety experienced by pregnant women during the antenatal period.

    3 months

Secondary Outcomes (1)

  • Prenatal Attachment Inventory

    3 months

Study Arms (2)

Haptonomy

EXPERIMENTAL

Pregnant women with prior abortion experience who will undergo haptonia treatment constitute the intervention group.

Behavioral: Haptonomy

Control

NO INTERVENTION

Pregnant women with a history of abortion and ongoing routine monitoring will be included in the control group.

Interventions

HaptonomyBEHAVIORAL

The intervention will be conducted at the antenatal clinic of a Training and Research Hospital. The training is planned to be conducted face-to-face in groups of 6-8 people in a suitable environment. Pregnant women included in the intervention group will receive a total of 5 haptonomy sessions, 2 sessions per week. Each haptonomy session is planned to last 45 minutes. Group rules will be determined before each training session begins. The training covers topics such as basic communication and bonding between mother and baby, energy work and visualization, baby communication through breathing techniques, baby communication through suggestion, and baby communication through touch techniques. The application program, determined according to the schedule, will continue until the last session is completed.

Haptonomy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous pregnant women with a history of abortion
  • Singleton pregnant women with a healthy pregnancy between 28 and 32 weeks
  • Women who conceived naturally
  • Pregnant women without psychiatric disorders
  • Pregnant women without a diagnosed genetic disease
  • Pregnant women without a history of two or more abortions

You may not qualify if:

  • Pregnant women diagnosed with high-risk pregnancies during the study
  • Pregnant women who were included in the study but could not be reached
  • Pregnant women who did not continue with the treatment during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Atabakhsh, T., Salehi, K., & Mohammadi, F. (2024). Investigating the impact of haptotherapy on maternal-fetal attachment in unplanned pregnancies. Journal of Education and Health Promotion, 13(1), 301.

    BACKGROUND
  • Nur Yilmaz, A., & Aksoy Derya, Y. (2025). The effects of haptonomy and virtual reality, anxiety, prenatal attachment and acceptance of pregnancy in unplanned pregnancy. Journal of Reproductive and Infant Psychology, 1-15.

    BACKGROUND
  • Alivand, Z., Nourizadeh, R., Hakimi, S., Esmaeilpour, K., & Mehrabi, E. (2025). The Effect of Haptonomy on Fear of Childbirth and Maternal-fetal Attachment: A Systematic Review and Meta-analysis. Current Psychiatry Research and Reviews, 21(4), 555-566.

    BACKGROUND
  • The effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment: randomized controlled experimental study

    BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

June 29, 2026

Study Completion (Estimated)

August 28, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly available due to participant confidentiality and ethical obligations. However, de-identified data may be obtained from the corresponding author upon reasonable request and with ethics committee approval.