NCT06070792

Brief Summary

The effect of neuro linguistic program and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy after caesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 19, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 19, 2023

Last Update Submit

September 3, 2024

Conditions

Keywords

NEURO LINGUISTIC PROGRAMPROGRESSIVE MUSCLE RELAXATION EXERCISESCAESAREAN SECTIONBREASTFEEDING SUCCESSBREASTFEEDING SELF-EFFICACY

Outcome Measures

Primary Outcomes (6)

  • BREASTFEEDING SUCCESS

    Breastfeeding Charting System (LATCH); The measurement tool has no cut-off point, and as the LATCH score increases, it is understood that the process is high. The maximum score that can be obtained is 10. The sum of lower scores indicates that the mother is dependent on help.

    immediately before the first application

  • BREASTFEEDING SUCCESS

    Breastfeeding Charting System (LATCH)

    immediately after the third application (at the 24th hour after the first application)

  • BREASTFEEDING SUCCESS

    Breastfeeding Charting System (LATCH)

    immediately after the sixth application (at the 48th hour after the first application)

  • BREASTFEEDING SELF-EFFICACY

    Breastfeeding Self-Efficacy Scale; A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All are positive elements. The higher the score from the scale, the higher breastfeeding self-efficacy will be achieved.

    immediately before the first application

  • BREASTFEEDING SELF-EFFICACY

    Breastfeeding Self-Efficacy Scale

    immediately after the third application (at the 24th hour after the first application)

  • BREASTFEEDING SELF-EFFICACY

    Breastfeeding Self-Efficacy Scale

    immediately after the sixth application (at the 48th hour after the first application)

Study Arms (3)

NEURO LINGUISTIC PROGRAM

EXPERIMENTAL

first experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes. In the NLP application; firstly, the most frequently used visual, auditory and/or tactile representation system of the woman will be determined. Then, the internal and external reactions caused by the symptoms after caesarean section, her feelings and thoughts about her baby and breastfeeding will be combined with the anchoring technique. Then, with the swish technique, the existing negative emotions will be reduced and tried to be deleted from the most frequently used representation system. The woman's negative thoughts about breastfeeding will be changed in a positive direction with the belief change model.

Other: NEURO LINGUISTIC PROGRAM

PROGRESSIVE MUSCLE RELAXATION EXERCISES

EXPERIMENTAL

second experimental group. It will be administered to primiparous mothers after caesarean section in the first 48 hours after the sixth postoperative hour, once every eight hours, for a total of six times. Each session will last 20 minutes. PMRE; All muscles of the body will be tried to be relaxed respectively with the commands given gradually.

Other: PROGRESSIVE MUSCLE RELAXATION EXERCISES

control

NO INTERVENTION

The control group will not receive NLP or PMRE.

Interventions

NEURO LINGUISTIC PROGRAM

NEURO LINGUISTIC PROGRAM

PROGRESSIVE MUSCLE RELAXATION EXERCISES

PROGRESSIVE MUSCLE RELAXATION EXERCISES

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimiparous mothers giving birth by caesarean section for the first time
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • women who gave birth by caesarean section,
  • primiparous,
  • who are 19 years of age or older and 35 years of age or younger,
  • who were born at 37 or more weeks of gestation,
  • who had a singleton birth,
  • whose caesarean section operation was performed with spinal anaesthesia,
  • who do not have chronic diseases and any breast-related health problems .

You may not qualify if:

  • who wanted to leave the study voluntarily at any stage after being included in the study,
  • who developed any health problems in themselves or their infants were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şanlıurfa training and research hospital

Sanliurfa, Eyalet/Yerleşke, 63000, Turkey (Türkiye)

Location

Related Publications (1)

  • Kilicli A, Gul S. The effect of neurolinguistic programming and progressive muscle relaxation exercises on breastfeeding success and breastfeeding self-efficacy: A randomized controlled trial. Explore (NY). 2024 Sep-Oct;20(5):103027. doi: 10.1016/j.explore.2024.103027. Epub 2024 Jul 2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gaziantep University Health Sciences Enstıtute, Department of Nursing, Department of Obstetrics and Gynaecology Nursing, PhD.

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 6, 2023

Study Start

October 1, 2023

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations