NCT06274138

Brief Summary

Pregnancies resulting from infertility treatment are considered normal and 'low-risk' in some countries, they often entail significant stress. Prenatal attachment may be experienced differently by parents conceiving through fertility interventions. The rising prevalence of fertility treatments is associated with increased risks such as preterm birth, low birth weight, and perinatal mortality for pregnancies achieved through infertility treatments. Beyond medical implications, post-infertility treatment pregnancies can induce high levels of anxiety and a perception of pregnancy as risky, affecting individuals psychologically. The transition to parenthood after infertility treatment can be psychologically challenging. Healthy prenatal attachment in expectant mothers fosters the development of a healthy role as both mother and father. Maternal bonding is closely tied to a woman's mental health during the prenatal period and her commitment to her baby. Similarly, prenatal bonding with the father sheds light on the emotional connection developing between the father and the unborn child. Active participation in prenatal experiences, such as attending ultrasound appointments or discussing parenting plans, contributes to a stronger sense of attachment for fathers and establishes a positive foundation for future bonding. Supportive partner relationships during pregnancy enhance paternal bonding and emphasize the importance of a collaborative approach to prenatal care for both parents. The prenatal period is critical for fathers to establish an early emotional connection with their unborn children, laying a positive groundwork for postnatal bonding. Various interventions aim to enhance communication between parents and augment prenatal attachment. One such practice is haptonomy-haptotherapy. Haptotherapy focuses on restoring emotional connections, especially with one's own body. It helps individuals recognize their emotional capacities and allows them to experience these capacities through insightful conversations, therapeutic touch, and skill exercises. In the context of pregnancy, haptonomy involves physical contact between the pregnant woman, her partner, and the unborn baby. Advocates of haptonomy believe that this touch-based communication can strengthen the bond between parents and the baby, promote a sense of security, and positively influence the pregnancy experience. Haptonomy is thought to contribute positively to the psychological well-being of women during pregnancy, birth, and the postpartum period, potentially preventing mental health issues and enhancing the health of both mother and baby. It is emphasized that haptonomy is a distinct practice focused on enhancing communication between parents and the baby. Existing literature suggests that haptonomy can increase emotional bonding during the prenatal period and may be effective for parents showing low attachment. Studies indicate that touch communication develops from the second month, involving vibrations for communicating with the fetus, ultimately increasing bonding through haptonomy. Furthermore, haptonomy is reported to enhance both spousal and parental attachment, as demonstrated in a study emphasizing increased attachment for fathers with their partners and children. Despite documented benefits of haptonomy in various patient groups, from cancer patients undergoing chemotherapy to pregnant women and those with chronic pain, limited research exists on haptotherapy for pregnant women. This study aims to investigate the impact of partner-administered haptonomy on prenatal attachment and marital adjustment in pregnant women. Conducted through a randomized controlled experimental design, the study seeks to provide evidence by enhancing prenatal attachments in both mothers and fathers. Research Hypotheses: H0-1: The application of haptonomy by partners has an effect on maternal attachment in pregnant women. H1-1: The application of haptonomy by partners does not have an effect on maternal attachment in pregnant women. H0-2: The application of haptonomy by partners has no effect on paternal attachment in pregnant women. H1-2: The application of haptonomy by partners has an effect on paternal attachment in pregnant women. H0-3: The application of haptonomy by partners has no effect on marital adjustment in pregnant women. H1-3: The application of haptonomy by partners has an effect on marital adjustment in pregnant women.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

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

First Submitted

Initial submission to the registry

February 7, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

November 1, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

February 7, 2024

Last Update Submit

October 31, 2024

Conditions

Keywords

haptonomypregnancyattachmentmarital adjustmentinfertility

Outcome Measures

Primary Outcomes (3)

  • Marital adjustment score

    Marital Adjustment Scale will be used to assess this outcome measure. Scores in the scale increase from incompatibility to compatibility. The lowest compliance score is 1 and the highest score is 60.

    pre-intervention, two weeks after the intervention, four weeks after the intervention

  • Prenatal attachment score

    Prenatal Attachment Inventory will be used to assess this outcome measure. A minimum of 21 and a maximum of 84 points can be obtained from the scale. As the scale score increases, attachment level increases.

    pre-intervention, two weeks after the intervention, four weeks after the intervention

  • Father attachment score

    Antenatal Father Attachment Scale will be used to assess this outcome measure. A minimum of 16 and a maximum of 80 points are obtained from the scale. As the scale score increases, attachment level increases.

    pre-intervention, two weeks after the intervention, four weeks after the intervention

Study Arms (2)

haptonomy

EXPERIMENTAL

Pregnant women in the intervention group will complete the Prenatal Attachment Scale and Marital Adjustment Scale, and fathers will complete the Antenatal Father Attachment Scale and Marital Adjustment Scale through face-to-face interviews. Information will be given that Haptonomy will consist of five sessions. Haptonomy will be applied by the researcher together with the partner. Each session will last for 40 minutes. The effectiveness and continuity of sessions will be planned between 3 to 7 days. One week after completing the five sessions of haptonomy, pregnant women will again complete the Prenatal Attachment Scale and Marital Adjustment Scale, and fathers will complete the Antenatal Father Attachment Scale and Marital Adjustment Scale through face-to-face interviews. The completion of the scales will take approximately 10-15 minutes.

Behavioral: haptonomy

control

NO INTERVENTION

Explanation of the purpose of the study will be provided to pregnant women and their partners, obtaining verbal and written consent. Pregnant women in the control group will complete the Prenatal Attachment Scale and Marital Adjustment Scale, and fathers will complete the Antenatal Father Attachment Scale and Marital Adjustment Scale through face-to-face interviews. The completion of the scales will take approximately 10-15 minutes.

Interventions

haptonomyBEHAVIORAL

Pregnant women in the intervention group will complete the Prenatal Attachment Scale and Marital Adjustment Scale, and fathers will complete the Antenatal Father Attachment Scale and Marital Adjustment Scale through face-to-face interviews. Information will be given that Haptonomy will consist of five sessions. Haptonomy will be applied by the researcher together with the partner. Each session will last for 40 minutes. The effectiveness and continuity of sessions will be planned between 3 to 7 days. One week after completing the five sessions of haptonomy, pregnant women will again complete the Prenatal Attachment Scale and Marital Adjustment Scale, and fathers will complete the Antenatal Father Attachment Scale and Marital Adjustment Scale through face-to-face interviews. The completion of the scales will take approximately 10-15 minutes.

haptonomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy after infertility treatment
  • weeks of gestation
  • Living with his/her spouse

You may not qualify if:

  • Outside the 28-36th gestational week
  • Living separately from his/her spouse
  • Having a risky pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • İlçim Ercan Koyuncu

    Baskent University

    STUDY DIRECTOR
  • Cansu Akdağ Topal

    Baskent University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 23, 2024

Study Start

September 15, 2024

Primary Completion

October 15, 2025

Study Completion

December 15, 2025

Last Updated

November 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations