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Pregnant WomenHaptonomyNCT07498088

THE EFFECT OF HAPTONOMY PRACTICE ON PREGNANT WOMEN WITH A HISTORY OF ABORTION.

A study testing Haptonomy in people with Pregnant Women, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnant Women
What is being tested?
Haptonomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Mar 2026to 27 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Üsküdar University

    Istanbul, Ümraniye, 34768

Other trials in Turkey (Türkiye)

About this study

Official title: THE EFFECT OF HAPTOTHERAPY APPLİCATİON ON PRE-NATAL ATTACHMENT AND ANXİETY LEVELS İN PREG-NANT WOMEN WİTH A HİSTORY OF ABORTİON

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.

Read the detailed description

Pregnancy is a multifaceted transformation in a woman's life that goes beyond biological changes, encompassing psychological, social, and existential dimensions. During this process, significant changes occur not only in the mother's body but also in her sense of identity, emotional regulation skills, and interpersonal relationships. As the fetus's neurodevelopmental capacity progresses, a reciprocal, interactive relationship begins to develop between mother and fetus, particularly from the second half of pregnancy onwards. This relationship is defined as the prenatal attachment process, which forms the basis of postnatal bonding. Prenatal attachment is a critical developmental area for the mother to mentally and emotionally represent her fetus, interact with it, and prepare for her role as a mother. This attachment process is influenced by numerous variables, including individual characteristics, psychological state, level of social support, and obstetric history. Experiences of loss before or during pregnancy can significantly alter the course of this process. Increased anxiety, feelings of uncertainty, and negative expectations are commonly observed in women who have experienced abortion, stillbirth, or neonatal loss in subsequent pregnancies. This situation can make it difficult for the mother to emotionally invest in the fetus, leading to delays or weakening of the bonding process. Anxiety and stress responses following prenatal loss experiences can affect not only the mother's mental health but also the physiological course of pregnancy and fetal development. Research shows that women who experience high levels of stress and anxiety during the prenatal period are more likely to have premature birth, low birth weight, and long-term cognitive and behavioral problems in their children. Therefore, it is important to provide psychosocial support to pregnant women, especially those in at-risk groups, and to implement interventions that will strengthen prenatal bonding. At this point, holistic approaches aimed at increasing mother-fetus interaction are noteworthy. Haptonomy, as a method based on tactile contact and emotional awareness, aims to support the establishment of a trust-based bond between mother and fetus. This approach is based on accepting not only the physical existence of the individual but also their emotional and existential integrity. During haptonomy interventions, the goal is to increase the expectant mother's awareness of her own body and emotions, and then to encourage conscious and reciprocal communication with the fetus. Including the partner in this process can contribute to strengthening family bonds. Current studies show that haptonomy can reduce perceived stress levels in pregnant women, alleviate fear of childbirth, and strengthen prenatal bonding. There is also evidence that this method can have positive effects on newborn behavior. However, studies examining the effects of haptonomy, particularly in pregnant women who have experienced prenatal loss, are limited. This indicates a significant research gap in identifying effective and applicable interventions in this population. This study aims to evaluate the effect of haptonomy intervention on prenatal bonding and anxiety levels in pregnant women who have experienced abortion. The study hypothesizes that haptonomy intervention will strengthen mother-fetus interaction by reducing anxiety, stress, and negative cognitive processes frequently observed in post-loss pregnancy. The results are expected to contribute to the development of evidence-based practices for supporting mental health during pregnancy and to provide guidance for improving the quality of care, particularly in high-risk pregnancy groups.

Conditions
Pregnant Women
Being tested
Haptonomy
Keywords
haptonomy, abortion, anxiety, attachment
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HaptonomyBehavioural

    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.

Study groups in NCT07498088
Study groupRoleWhat they receive
HaptonomyExperimentalPregnant women with prior abortion experience who will undergo haptonia treatment constitute the intervention group.
Receives: Behavioral: Haptonomy
ControlNo interventionPregnant women with a history of abortion and ongoing routine monitoring will be included in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prenatal Attachment Inventory

    Developed by Müller in 1993, the Prenatal Attachment Inventory (PAI) is used to describe the emotions, thoughts, and situations experienced by women during pregnancy and to determine their level of attachment to the baby during the prenatal period. It consists of 21 items. Each item is scored on a 4-point Likert scale, ranging from 1 to 4: 1: Never, 2: Sometimes, 3: Frequently, 4: Always. The minimum score is 21, and the maximum is 84. A higher score indicates a higher level of attachment. In a validity and reliability study of the inventory by Dereli Yılmaz and Kızılkaya Beji (2013), the Cronbach Alpha value was found to be 0.84.

    Measured: 3 months

Secondary outcomes (1)
  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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start30 Mar 2026
  3. Primary completion29 Jun 2026
  4. Study completion27 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498088
Sponsor's protocol ID
UU-SBF-BF-01
Acronym
Haptonomy
Status last verified
Aug 2026
First submitted
23 Mar 2026
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Atabakhsh T, Salehi K, Mohammadi F. Investigating the impact of haptotherapy on maternal-fetal attachment in unplanned pregnancies. J Educ Health Promot. 2024 Aug 29;13:301. doi: 10.4103/jehp.jehp_8_24. eCollection 2024.

    PubMed 39429827
  • Nur Yilmaz A, Aksoy Derya Y. The effects of haptonomy and virtual reality, anxiety, prenatal attachment and acceptance of pregnancy in unplanned pregnancy. J Reprod Infant Psychol. 2026 Sep;44(5):1301-1315. doi: 10.1080/02646838.2025.2539989. Epub 2025 Jul 25.

    PubMed 42610239
  • 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.

  • Ozbek H, Pinar SE. The effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment: randomized controlled experimental study. Curr Psychol. 2022 Jul 16:1-10. doi: 10.1007/s12144-022-03388-1. Online ahead of print.

    PubMed 35874964

Questions about this trial

What is this clinical trial studying?

A study testing Haptonomy in people with Pregnant Women, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prenatal Attachment Inventory (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498088, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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