Clinical trial NCT06987331: The Effect of Haptonomy and Conscious Awareness Applied to Pregnant Women on Prenatal Breastfeeding Self-efficacy and Infant Feeding Attitudes
Official title: The Effect of Haptonomy and Conscious Awareness Applied to Pregnant Women on Prenatal Breastfeeding Self-efficacy and Infant Feeding Attitudes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pregnancy
Keywords: mindfulness
pregnancy
haptonomy
infant feeding
breastfeeding self-efficacy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study was conducted as a randomised controlled experimental research. There are two different experimental groups in the study: Haptonomy and Mindfulness groups. The researcher has haptonomy and mindfulness certificates. The minimum sample size was calculated as 40 people for each group in total (40 haptonomy, 40 mindfulness, 40 control group) in order to reach an effect size of 0.70and 0.87 power at 5% margin of error in G-Power 3.1.9.4 programme. The data were collected by the researcher at the ASM. Haptonomy and Mindfulness practices were conducted twice a week for 4 weeks with a total of eight 30-minute interviews. Pregnant women in the experimental group were met at the first encounter and filled out the Infant Feeding Attitude Scale and Prenatal Breastfeeding Self-Efficacy Scale and Pregnant Information Form as pre-tests and post-tests were performed after the training.
Primary purpose: OTHER

Brief summary: Breast milk is an invaluable source of infant nutrition and has numerous benefits for mother and infant . Despite the benefits of breastfeeding, breastfeeding rates remain well below the level recommended by the World Health Organisation. According to the Turkish Demographic and Health Survey (TDHS) 2018 data, only 41% of infants younger than six months are breastfed and this rate decreases rapidly after the sixth month. World Health Organization (WHO), UNICEF (United Nations Children's Fund) data and studies indicate that mothers should be supported in breastfeeding and breastfeeding rates are insufficient . In order for breastfeeding rates to reach the desired level, the updated WHO guidelines on breastfeeding state that 'counselling should be provided to pregnant women and their families about the benefits and management of breastfeeding in places where antenatal care is provided' . There are many studies showing that education and training related with breastfeeding have positive effects on mothers' desire to breastfeed, breastfeeding self-efficacy, frequency of breastfeeding problems, early initiation of breastfeeding, and increased duration of breastfeeding . It has been reported that breastfeeding trainings are effective in the cognitive process and the increase in the cognitive development of women positively affects breastfeeding .

It is known that some alternative medicine methods such as music therapy, relaxation exercises and hypnosis applied during pregnancy are beneficial in breastfeeding . Haptonomy is one of the relaxation methods used in the prenatal period and is based on touching for healing. This method, which aims to develop a more positive attitude towards pregnancy and birth, is an approach in which the body and mind are considered as a whole. In general, haptonomy can be defined as a method based on body-affect-mind integrity . In the literature, it has been reported that haptonomy provides faster and easier establishment of the bond between mother, father and baby and also plays an important role in reducing birth-related complications and postpartum problems . In studies, it has been reported that haptonomy is effective in increasing the level of prenatal attachment and acceptance of pregnancy, increases the level of attachment to their babies in pregnant women and reduces the fear of birth(. It is known that haptonomy practice supports the mother's adaptation to pregnancy, psychological preparation for birth and transition to parenthood. It is also emphasised that it plays an important role in terms of psycho-physical comfort of the baby. It has been reported that haptonomy is beneficial for parents, baby and family and has a supportive effect on the practices of midwives, nurses and other health professionals . When the national and international literature is analysed, it is stated that there are not enough scientific studies despite the benefits of haptonomy .

Another method used during pregnancy is mindfulness. Mindfulness is an old Buddhist approach and its simplest definition is the art of living consciously and is defined as a type of meditation that improves the individual's ability to focus on what is happening in an accepting way . In a meta-analysis study, it was reported that mindfulness-based interventions may be useful for mindfulness levels in the perinatal period . It was reported that mindfulness interventions applied by nurses to improve maternal outcomes in pregnancy education classes had positive effects on maternal well-being . AIt is reported that the care of pregnant women is beneficial for the baby's health. . In the literature, there are many studies on the effects of mindfulness on pregnant women and newborns .

Prenatal maternal well-being has a significant effect on both mother and foetus. Therefore, it is of great importance to develop and evaluate strategies and interventions to increase well-being. Nurses' integration of mindfulness and haptonomy practices into patient care and education may positively affect women's health outcomes. In order to support the independent roles of nurses, these practices should be included in routine pregnancy and postpartum period trainings. In the literature, no study comparing haptonomy and mindfulness during pregnancy was found. However, the use of these practices in the prenatal period may contribute to the reduction of problems that may be encountered in the postpartum period and to the increase in maternal well-being. As a result, breastfeeding and infant feeding attitudes may also be positively affected and this study was planned.


Eligibility criteria: Inclusion Criteria:

* No verbal communication problems
* Not being diagnosed with psychological illness
* A singleton and viable pregnancy,
* No recognised pregnancy-related risk (such as pre-eclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
* The fetus does not have any diagnosed health problems (such as fetal anomaly, intrauterine growth retardation)

Exclusion Criteria:

* Conceived with assisted reproductive techniques,
* Less than 20 weeks and \>32 weeks of gestation
* Existing chronic disease history

Primary outcomes:
measure: the effect of haptonomy and mindfulness applied to pregnant women on prenatal breastfeeding self-efficacy and infant feeding attitude
timeFrame: 8 WEEK
Secondary outcomes:
measure: the effect of haptonomy and mindfulness applied to pregnant women on prenatal breastfeeding self-efficacy and infant feeding attitude
timeFrame: 8 week
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Akdağmadeni state hospital
state: Akdağmadeni
Study officials:
affiliation: Bağlı Olmayan
name: Demirtaş Alpsalaz
role: PRINCIPAL_INVESTIGATOR
References: