NCT06610084

Brief Summary

Topic: The World Health Organisation (WHO) states that breastfeeding is of great importance for the healthy growth and development of infants as well as for maternal health. Breast milk is a unique and irreplaceable food. Breast milk is the most natural food for infant nutrition and contains all the nutrients, vitamins and minerals needed by the baby. Breast milk provides sensory and cognitive development and helps to protect the baby against all kinds of infectious and chronic diseases . The benefits of breastfeeding are not limited to infant health. Breastfeeding is also of great importance for maternal and public health. According to TDHS 2018 data, the proportion of exclusively breastfed infants decreases rapidly with age, from 59% among 0-1 month-olds to 45% among 2-3 month-olds and 14% among 4-5 month-olds. Accordingly, it is observed that the rate of breastfeeding maintenance is low in Turkey. Breastfeeding motivation and breastfeeding self-efficacy are modifiable factors in initiating and maintaining breastfeeding. It has been found that breastfeeding duration of mothers with high breastfeeding motivation is longer.. In studies, breastfeeding self-efficacy of adult women has been defined as an important variable affecting breastfeeding outcomes. Especially prenatal breastfeeding self-efficacy has been shown to predict breastfeeding intentions and the predicted length of breastfeeding. In the literature, it was reported that mothers with low breastfeeding self-efficacy perception discontinued breastfeeding in a short period of time after delivery, whereas mothers with high breastfeeding self-efficacy perception did not have any difficulty in initiating and maintaining breastfeeding. Pharmacological and nonpharmacological interventions have been focused on to increase prolactin secretion and breast milk production of mothers in the postpartum period.These interventions will decrease the stress and anxiety of the mother and help breastfeeding by increasing breastfeeding motivation and breastfeeding self-efficacy. Therefore, nonpharmacological methods for increasing lactation and elimination of breast problems are important in terms of both breastfeeding and continuity of breastfeeding. Practices used to increase lactation include kangaroo care, back massage, yoga, breast massage, compression, acupuncture, acupressure, music therapy, aromatherapy, herbal tea use and galactagogues techniques. Hypno-breastfeeding and progressive muscle relaxation exercise used in this study are among these practices. Hypno-breastfeeding is hypnosis that helps to increase breast milk and is performed with a hypnotherapist who pays attention to the unity of body, mind and spirit and its philosophy is based on hypnosis and breastfeeding programme.Progressive muscle relaxation exercise has also been found to increase breastfeeding self-efficacy. As a result of active contraction and passive relaxation of 16 muscle groups, the person relaxes physiologically by decreasing the activity of the sympathetic nervous system and increasing the activity of the parasympathetic nervous system. 16 muscle groups actively contracted and passively relaxed, it was found that the person relaxed physiologically by decreasing the activity of the sympathetic nervous system and increasing the activity of the parasympathetic nervous system. Relaxation has been shown to effectively improve perceived stress levels and to be effective in helping people control their emotions and behaviours in many situations such as pain, labour, anxiety and insomnia. With the comfort provided by relaxation, the mother\'s orientation towards breastfeeding will increase. Hypno-breastfeeding and progressive muscle relaxation exercise will have an effect on increasing breastfeeding motivation and breastfeeding self-efficacy.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
suspended

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 24, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

September 17, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

breastfeedingself efficacybreastfeeding motivation

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale Short Form

    It is a 33-item scale prepared by Dennis and Faux (127) in 1999 to assess breastfeeding self-efficacy levels. A short form of the 14-item Breastfeeding Self-Efficacy Scale was developed by Aluş-Tokat et al. in 2010. The scale is 5-point Likert type. The lowest score that can be obtained from the scale is 14 and the highest score is 70. The scale has no cut-off point. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy. Cronbach Alpha value of the scale is 0.94. (Aluş-Tokat \& Okumuş, 2010).

    3 month

Secondary Outcomes (2)

  • Breastfeeding Self-Efficacy Scale

    3 month

  • Primiparous Breastfeeding Motivation Scale

    3 month

Study Arms (2)

Hypno-breastfeeding

EXPERIMENTAL

The research was conducted in a total of 6 sessions. Session 1 (32nd week): After the introduction, hypno-breastfeeding practice was performed face-to-face. Session 2 (33rd-34th week): Hypno-breastfeeding practice was repeated with online interviews. Session 3 (35th week): Hypno-breastfeeding practice was repeated face-to-face. Session 4 (36th week): Hypno-breastfeeding practice was repeated online. Session 5 (37th week): Hypno-breastfeeding practice was repeated face-to-face. Session 6 (38th-40th week): Hypno-breastfeeding practice was performed in the ward at the 8th hour postpartum. Postpartum 2nd to 4th week: The audio recording prepared by the researcher was used for the hypno-breastfeeding application given to the mother. The researcher guided the mother to perform the application once a day and followed up with daily telephone calls. Translated with DeepL.com (free version)

Other: Hypno-breastfeeding

progressive muscle relaxation exercise

EXPERIMENTAL

Applications for experimental group 2 (progressive muscle relaxation exercise) The research was conducted in a total of 6 sessions. Session 1 (32nd week): After the introduction, progressive muscle relaxation exercise was performed face-to-face. Session 2 (Week 33-34): Progressive muscle relaxation exercise was repeated with online interview. Session 3 Week 35: In Phase 3, the progressive muscle relaxation exercise was repeated face-to-face. Session 4 Week 36: Progressive muscle relaxation exercise was repeated online. Session 5 Week 37: Progressive muscle relaxation exercise, repeated face-to-face. Session 6 38.-40th Week: It was performed in the ward at the 8th hour postpartum. Postpartum 2nd to 4th week: The video prepared by the researcher was used for the progressive relaxation exercise training given to the mother. The researcher guided the mothers to perform the practice once a day and follow-up was ensured through daily telephone calls.

Other: progressive muscle relaxation exercise)

Interventions

Applications for experimental group 2 (progressive muscle relaxation exercise) The research was conducted in a total of 6 sessions. Session 1 (32nd week): After the introduction, progressive muscle relaxation exercise was performed face-to-face. Session 2 (Week 33-34): Progressive muscle relaxation exercise was repeated with online interview. Session 3 Week 35: In Phase 3, the progressive muscle relaxation exercise was repeated face-to-face. Session 4 Week 36: Progressive muscle relaxation exercise was repeated online. Session 5 Week 37: Progressive muscle relaxation exercise, repeated face-to-face. Session 6 38.-40th Week: It was performed in the ward at the 8th hour postpartum. Postpartum 2nd to 4th week: The video prepared by the researcher was used for the progressive relaxation exercise training given to the mother. The researcher guided the mothers to perform the practice once a day and follow-up was ensured through daily telephone calls.

progressive muscle relaxation exercise

Practices for experimental group 1 (Hypno-breastfeeding) The research was conducted in a total of 6 sessions. Session 1 (32nd week): After the introduction, hypno-breastfeeding practice was performed face-to-face. Session 2 (33rd-34th week): Hypno-breastfeeding practice was repeated with online interviews. Session 3 (35th week): Hypno-breastfeeding practice was repeated face-to-face. Session 4 (36th week): Hypno-breastfeeding practice was repeated online. Session 5 (37th week): Hypno-breastfeeding practice was repeated face-to-face. Session 6 (38th-40th week): Hypno-breastfeeding practice was performed in the ward at the 8th hour postpartum. Postpartum 2nd to 4th week: The audio recording prepared by the researcher was used for the hypno-breastfeeding application given to the mother. The researcher guided the mother to perform the application once a day and followed up with daily telephone calls.

Hypno-breastfeeding

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was planned on pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • Literate,
  • Can understand and speak Turkish,
  • A singular pregnancy,
  • Gestation period of 32 weeks or more,
  • She\'s scheduled to give birth by caesarean section,
  • Volunteered to participate in the research, primiparous pregnant women were included in the study.

You may not qualify if:

  • \- Having developed any complications in herself and the newborn during pregnancy, labour and postnatal period,
  • Chronic opioid, antidepressant, psychoactive drug users,
  • Communication problems primiparous pregnant women were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO Unıversity

Gaziantep, Şehitkamil, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This research is a randomised controlled experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 24, 2024

Study Start

June 24, 2024

Primary Completion

March 28, 2025

Study Completion

May 16, 2025

Last Updated

September 24, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Study ProtocolStatistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
June 24-March 28
Access Criteria
ipd other researcher will access the full research protocol by email from the researcher.

Locations