NCT06987331

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

1 year

First QC Date

April 26, 2025

Last Update Submit

May 15, 2025

Conditions

Keywords

mindfulnesspregnancyhaptonomyinfant feedingbreastfeeding self-efficacy

Outcome Measures

Primary Outcomes (1)

  • the effect of haptonomy and mindfulness applied to pregnant women on prenatal breastfeeding self-efficacy and infant feeding attitude

    prenatal breastfeeding self-effıcacy scale It was developed by Wells et al. (2006) to determine the breastfeeding self-efficacy perceptions of pregnant women in the prenatal period. The validity and reliability study of the scale in Turkish was conducted by Aydın and Pasinlioglu (2018) and the Cronbach's alpha coefficient of the scale was 0.85. The scale consists of a total of 20 items and four subgroups. These are; general information (items 1, 2, 3, 5, 17), skills and demands (items 6, 7, 8, 9, 10, 11, 12, 20), breastfeeding and relationship with other people (items 13, 14, 15, 16) and social pressure (items 4, 18, 19). Each item of the scale was graded on a 5-point Likert scale, where 1=Not sure at all, 2=Somewhat sure, 3=Quite sure, 4=Very sure, 5= Absolutely sure. The lowest score that can be obtained from the total scale is 20 and the highest score is 100. A high score indicates high breastfeeding self-efficacy.

    8 WEEK

Secondary Outcomes (1)

  • the effect of haptonomy and mindfulness applied to pregnant women on prenatal breastfeeding self-efficacy and infant feeding attitude

    8 week

Study Arms (1)

The effect of haptonomy and mindfulness applied to pregnant women on breastfeeding and infant nutrit

EXPERIMENTAL

Haptonomy and mindfulness were applied to pregnant women in two of the three groups as two experimental and one control group.

Other: haptonomyBehavioral: Haptonomy applicationBehavioral: Mindfulness

Interventions

Haptonomy involves a combination of skills taught in 4-8 sessions of 45-60 minutes between 20 and 36 weeks of gestation. An important stage of the three-step haptonomy application is the attachment of the parents to the foetus by touching the foetus in the 20-36th weeks of pregnancy. Mindfullnes is a mbsr application done in 8 sessions

The effect of haptonomy and mindfulness applied to pregnant women on breastfeeding and infant nutrit

breastfeeding status

The effect of haptonomy and mindfulness applied to pregnant women on breastfeeding and infant nutrit
MindfulnessBEHAVIORAL

breastfeeding status

The effect of haptonomy and mindfulness applied to pregnant women on breastfeeding and infant nutrit

Eligibility Criteria

Age18 Months - 48 Months
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsapplied to pregnant women
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdağmadeni state hospital

Yozgat, Akdağmadeni, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Demirtaş Alpsalaz

    Bağlı Olmayan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2025

First Posted

May 23, 2025

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 23, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The effect of haptonomy and mindfulness applied to pregnant women on prenatal breastfeeding self-efficacy and infant feeding attitude

Shared Documents
STUDY PROTOCOL
Time Frame
december 2025-2026
Access Criteria
users
More information

Available IPD Datasets

Statistical Analysis Plan Access

Locations