NCT06824337

Brief Summary

This study was planned to evaluate the effect of early mobilization training given to patients undergoing cesarean section in the preoperative period and targeted mobilization program applied after the surgery, on preventing gastrointestinal complications that may develop after the surgical intervention and participating in breastfeeding and baby care. The research will be conducted in experimental design. The research will begin after receiving written permission from Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate and Ömer Halisdemir Training and Research Hospital. Pregnant women who are between the ages of 18-35, who are at least a primary school graduate, who gave birth at term, who have a live singleton pregnancy, and who do not have a risky pregnancy history (DVT, thromboembolism) will be included in the study. Before starting the research, the study will begin by obtaining institutional permissions and written permission from the pregnant women. Personal Information Form prepared in line with the literature, postoperative gastrointestinal functions information form, postoperative abdominal distension diagnosis form, walking chart, VAS, LATCH Breastfeeding Diagnosis and Evaluation Scale and Breastfeeding Information Form data collection forms will be used to collect data. The data will be evaluated on a computer using the IBM SPSS Statistics 24 (Statistical Package for the Social Sciences for Windows) package program. Appropriate statistical analyzes will be used to evaluate the data

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 13, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 18, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

Caesarean sectionmobilizationpainbreastfeeding

Outcome Measures

Primary Outcomes (3)

  • Postoperative Gastrointestinal Functions Information Form

    The form, which will evaluate women's postoperative GI functions, includes six questions that evaluate the time and amount of oral intake after surgery, the time of first gas and defecation, and nausea and vomiting.

    3 month

  • Postoperative Abdominal Distension Diagnosis Form

    The form is a measurement tool that evaluates abdominal distension status at 6, 12, 24 and 48 hours after surgery using a scale ranging from 0 (no distension) to 10 (the most severe distension possible)

    3 month

  • VAS (Visual Analog Scala)

    It consists of a 10 cm long horizontal or vertical line, which is often used to measure subjective parameters. One end of the line indicates 0 = "no pain", the other 10 = worst/unbearable pain.

    3 month

Secondary Outcomes (2)

  • LATCH Breastfeeding Diagnostic and Assessment Scale

    3 month

  • Breastfeeding Information Form

    3 month

Study Arms (2)

Experimental group

EXPERIMENTAL

The first interview with the intervention group patients will be held when the patients arrive at the hospital. In these interviews, the patients will first be introduced to the patients, detailed information will be provided about the research, their verbal/written informed consent will be obtained, and answers will be obtained to the questions in the patient information form. In addition, the content of the early mobilization training given to the patients in the first interview, what early mobilization is, why it is important, what benefits it provides, what the mobilization goals determined for the patient within the scope of the research are, the benefits of walking and the expected results will be explained. It will be explained how to benefit from the smartphone during the mobilization process. In addition to all the training, the patients in the intervention group will be given detailed information about what they need to record in the mobilization diary (total time they walke

Other: mobilization training and targeted mobilization

control group

NO INTERVENTION

Women in the control group will be left to the routine care of the institution. Within the scope of routine care, women in this group will be asked to record their walking distance.

Interventions

In the first interview with the patients, the content of the early mobilization training given to the patients, what early mobilization is, why it is important, what benefits it provides, what the mobilization goals determined for the patient within the scope of the research, the benefits of walking and the expected results will be explained. It will be explained how to benefit from the smartphone during the mobilization process. In addition to all the training, the patients in the intervention group will be given detailed information about what they need to record in the mobilization diary (total time they walked, how many steps they took in the pedometer application after each mobilization, positive/negative situations they experienced while standing up and walking) and all the forms that will be used in the data collection phase.

Experimental group

Eligibility Criteria

Age18 Months - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprimipara women
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between the ages of 18-35,
  • At least primary school graduate,
  • Giving birth at term
  • Having a live singleton pregnancy,
  • No risky pregnancy history (DVT, thromboembolism)
  • Women who can use a mobile phone

You may not qualify if:

  • Those who want to leave the study,
  • Undergoing emergency caesarean section,
  • Not recording walking distance
  • Women who cannot be interviewed within 24 hours of discharge
  • Women who develop maternal or neonatal complications after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir Univercity

Niğde, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainBreast Feeding

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • isa temur, Dr

    NİĞDE ÖMER HALİSDEMİR UNIVERCITY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BİRNUR YEŞİLDAĞ, DR.

CONTACT

birnur yeşildağ, dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The research is a two-group parallel randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2024

First Posted

February 13, 2025

Study Start

December 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

February 13, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations