Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06274138 |
| Other study ID # |
HAPTONOMY |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2024 |
| Est. completion date |
March 15, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Baskent University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study Design A randomly clinical trial with pre-session and post-session, was conducted.
Participants and blindly and randomly allocated to the intervention group (haptonomy) or the
control group, using a random number generator by the researcher.
Participants and procedures The population of the study consists of pregnant women and their
partners who are being followed up at the Başkent University Ankara Hospital IVF Center
between December 25, 2023, and December 25, 2024, and have become pregnant through
infertility treatment, ranging from the 20th to the 28th week of pregnancy. The sample of the
study will consist of pregnant women who meet the inclusion criteria and agree to participate
in the research. The sample size was calculated by conducting a power analysis using the
G*Power program and referring to previous studies. According to the power analysis, with an
effect size of 0.70 and a 5% margin of error, a minimum sample size of 68 individuals (34
experimental, 34 control) is required to achieve a power of 0.80. Considering possible data
losses, a total of 76 individuals (38 experimental, 38 control) will be included in the
study. The randomization of the sample will be determined by entering the total number of
cases into the program at the URL address https://www.randomizer.org. Before entering the
data into the program, it is assumed that set 1 will represent the control group, and set 2
will represent the intervention group. The program will determine the random order of the
cases comprising the sample group through the randomization method. Participants eligible for
this study must have successfully achieved pregnancy through infertility treatment. They
should currently be in the 20th to 28th week of pregnancy and must be living together with
their spouse. Those who fall outside the 20th to 28th week of pregnancy, individuals living
separately from their spouse, and those experiencing a high-risk pregnancy will not be
included in the study.
Outcome measures Sociodemographic form Sociodemographic form, which was constructed by the
researcher based on the literature, included questions about the week of pregnancy, age,
education, socioeconomic status, and questions to assess fetal-parent communication.
Marital Adjustment Scale (MAS):
The MAS, developed by Locke and Wallace (1959) and adapted to Turkish by Tutarel-Kışlak
(1999), consists of 15 items. Scores on the scale increase from discordance to harmony. The
lowest adjustment score is 1, and the highest is 60. The scale assesses happiness levels in
marriage, with questions 2 and 9 measuring disagreements between spouses based on specified
criteria.
Prenatal Attachment Inventory (PAI):
Developed in 1993 by Muller and Mercer, the PAI aims to understand pregnant women's thoughts
and feelings throughout pregnancy and determine their attachment levels to the baby during
the prenatal period. The Turkish version's reliability is established by Yılmaz and Beji
(2013). The scale consists of items scored on a 1-4 Likert scale.
Antenatal Father Attachment Scale (AFAS):
The AFAS, developed by John Condon (1993), comprises 16 items as a 5-point Likert scale to
measure fathers' emotions, thoughts, attitudes, and behaviors related to their unborn babies.
The Turkish validity and reliability study is conducted by Benli and Aksoy Derya (2019).
Study Variables:
The study will measure the mean scores of the prenatal attachment scale for pregnant women.
Mean scores of the antenatal father attachment scale will be assessed for fathers. The
marital adjustment scale will be utilized to determine the mean scores for both mothers and
fathers. The independent variable in this study is the application of Haptonomy.
Data Collection procedure:
The study will involve pregnant women and their partners receiving haptonomy in the
intervention group and those in the control group continuing routine follow-ups. Comparison
of attachment and marital adjustment scores between the intervention and control groups will
be conducted. Both groups will undergo the following procedures:
Intervention Group:
Explanation of the purpose of the study and information about Haptonomy will be provided to
pregnant women and their partners, obtaining verbal and written consent. 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.
Control Group:
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.
Statistical Analysis:
Data will be analyzed using the licensed IBM SPSS 23 software. Descriptive statistics such as
numbers, percentages, means, and standard deviations will be used. Normal distribution will
be assessed using the Kolmogorov-Smirnov test. For binary group comparisons, the independent
samples t-test or Mann-Whitney U Analysis will be used based on normality. For within-group
comparisons, the paired samples t-test or Wilcoxon analysis will be applied for normal and
non-normal distributions, respectively. Results will be evaluated at a 95% confidence
interval, and significance will be set at p < 0.05.
