Caesarean SectionMobilizationNCT06824337
Effect of Targeted Mobilization Program
A study testing mobilization training and targeted mobilization in people with Caesarean Section and Mobility, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 months to 35 years, women only
- Conditions the study is for
- Caesarean Section, Mobility, Pain
- What is being tested?
- mobilization training and targeted mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Ömer Halisdemir Univercity
Niğde
05336815923
About this study
Official title: Effect of Targeted Mobilization Program Applied After Caesarean Section Surgery on Care Outcomes: Randomized Controlled Study
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
Read the 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.
- Conditions
- Caesarean Section, Mobility, Pain, Breastfeeding
- Being tested
- mobilization training and targeted mobilization
- Keywords
- Caesarean section, mobilization, pain, breastfeeding
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization training and targeted mobilizationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 3 month
Secondary outcomes (2)
LATCH Breastfeeding Diagnostic and Assessment Scale
Each criterion that makes up the LATCH Breastfeeding Diagnosis and Assessment Scale is given a score of 0, 1, or 2. Breastfeeding success is assessed by adding the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0.
Measured: 3 month
Breastfeeding Information Form
The form consists of six questions to determine the breastfeeding status, frequency and participation in baby care of women on days 0, 1 and 2 after surgery.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Dec 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a two-group parallel randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- isa temur, Dr, Principal investigator, NİĞDE ÖMER HALİSDEMİR UNIVERCITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824337
- Sponsor's protocol ID
- 22504254-050.04
- Acronym
- Mobilization
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Mobilization Program Applied After Caesarean Section Surgery on Care Outcomes: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06824337
- Acronym / sponsor ID
- Mobilization / 22504254-050.04
- Conditions
- Caesarean Section, Mobility, Pain, Breastfeeding
- Keywords
- Caesarean section, mobilization, pain, breastfeeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research is a two-group parallel randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: mobilization training and targeted mobilizationThe 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 |
| 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. |
Who may qualify
- Ages
- 18 months to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobilization training and targeted mobilizationIn 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. | Other | Experimental group |
Primary outcome
Postoperative Gastrointestinal Functions Information Form
Time frame: 3 month
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.
Postoperative Abdominal Distension Diagnosis Form
Time frame: 3 month
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)
VAS (Visual Analog Scala)
Time frame: 3 month
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.
2 secondary outcomes
LATCH Breastfeeding Diagnostic and Assessment Scale
Time frame: 3 month
Breastfeeding Information Form
Time frame: 3 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
isa temur, Dr principal investigator
NİĞDE ÖMER HALİSDEMİR UNIVERCITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization training and targeted mobilization in people with Caesarean Section and Mobility, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BİRNUR YEŞİLDAĞ, DR. (+90 05336815923, nurumbirnur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Gastrointestinal Functions Information Form (time frame: 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.