Clinical trial NCT06824337: Effect of Targeted Mobilization Program
Official title: Effect of Targeted Mobilization Program Applied After Caesarean Section Surgery on Care Outcomes: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caesarean Section
Mobility
Pain
Breastfeeding
Keywords: Caesarean section
mobilization
pain
breastfeeding
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is a two-group parallel randomized controlled experimental study.
Primary purpose: PREVENTION

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

Detailed description: Cesarean section is life-saving for the mother and baby when necessary, but it can increase maternal mortality and morbidity rates when compared to vaginal birth. Cesarean section rates are increasing by 4% each year in the world. FIGO which took place in Brazil in 2018, reported that cesarean section rates doubled between 2000 and 2015, revealing a serious problem globally . When cesarean section rates were compared between 2000 and 2015, it was determined that they increased from 19.6% to 26.9% in Western Europe, from 32.3% to 44.3% in Latin America, and from 7.2% to 18.1% in South Asia. The cesarean section rate in Turkey was 21.2% in 2003, 36.7% in 2008, and increased to 48.5% in 2013. The significant increase in the number of cesarean sections performed each year worldwide has made postoperative care even more important. As in all abdominal surgeries, delayed gas release, delayed return of bowel movements, delayed resumption of oral intake, wound healing, urinary retention, atalactasia, bleeding, adhesion, hematoma, thrombophlebitis, venous and pulmonary embolism, coagulopathies, and anesthesia-related problems are observed after cesarean surgery. In addition, problems such as failure to participate in baby care and delay in starting breastfeeding are also encountered. Early mobilization is very valuable to prevent these complications, and studies argue that early mobilization can prevent negative outcomes related to many systems in the body. In the ERAS guideline created specifically for patients undergoing cesarean section, although it is stated that there are no randomized controlled trials with strong methodology regarding early mobilization, it is recommended that patients after cesarean section should also be mobilized early (Very low-level evidence, weak recommendation). Although early mobilization is considered an important element of postoperative care, it is not yet fully known how to best implement it in clinical practice. Because there are limited scientific studies in the literature supporting the superiority of any mobilization program over another. The independent positive contributions of early mobilization to postoperative patient outcomes are accepted, the importance of timing is emphasized, but there is not yet sufficient evidence regarding the effect of frequency and duration on patient outcomes, there is a need for scientific studies emphasizing the importance of an early mobilization plan structured with daily written goals starting from the day of surgery, including getting out of bed and walking distances. In preoperative patient education, determining postoperative step goals and using a pedometer to achieve these goals and/or keeping a mobilization diary are stated as other practices that can increase patients' compliance with postoperative mobilization programs. The participation of nurses, who are involved in all processes of surgery, in the patient education phase is also very important and nurses should be the most competent team members in the implementation of standardized early mobilization protocols. Therefore, nurses should focus on developing and implementing protocols that aim to minimize the dependency of hospitalized patients on nurses, encourage mobilization, and prevent a decrease in functionality. Thus, nurses will be able to assume more roles and responsibilities in ensuring early mobilization. No study has been found in the literature in which a targeted mobilization program was implemented in cesarean surgery. In this context, the study is planned to evaluate the effect of early mobilization education given to patients undergoing cesarean section in the preoperative period and the targeted mobilization program applied after surgery on preventing gastrointestinal complications that may develop after surgery and participating in breastfeeding and baby care.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Exclusion Criteria for the Study
* 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

Primary outcomes:
measure: Postoperative Gastrointestinal Functions Information Form
timeFrame: 3 month
measure: Postoperative Abdominal Distension Diagnosis Form
timeFrame: 3 month
measure: VAS (Visual Analog Scala)
timeFrame: 3 month
Secondary outcomes:
measure: LATCH Breastfeeding Diagnostic and Assessment Scale
timeFrame: 3 month
measure: Breastfeeding Information Form
timeFrame: 3 month
Other outcomes:
Locations:
city: Ni̇ğde
country: Turkey
facility: Niğde Ömer Halisdemir Univercity
Study officials:
affiliation: NİĞDE ÖMER HALİSDEMİR UNIVERCITY
name: isa temur, Dr
role: PRINCIPAL_INVESTIGATOR
References: