- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05499208
Rotation and Movement System, Postpartum Cesarean Sections (Rotation)
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
In the first half hour of a cesarean advertisement, the service-oriented mother will not be mobile and will need support to get fit in bed and start getting started. The patient turning and movement system will provide a lot of convenience to the mother who does not have enough support.
With the remote control system, the mother will be easily turned to the desired side in the bed and it will be ensured that she takes the desired position with less pain and more comfort.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kars, Turkey, 36100
- Kars Harakani State Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being between the ages of 18-35.
- Primiparity.
- Having a transverse cesarean section.
- At least primary school graduate.
- No high-risk pregnancy.
- Absence of any complications in the puerperal and newborn during the delivery and postnatal period
Exclusion Criteria:
- Having an open wound on the body and/or an allergic disease diagnosis on the skin.
- Development of puerperal complications (bleeding, infection, fever).
- At risk of convulsions; have diseases such as eclampsia, epilepsy.
- Having a body mass index above 40 (morbidly obese).
- Having any contraindications for breastfeeding.
- Having chronic opioid, antidepressant, and psychoactive drug use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Giving side position with patient turning and movement system
On the day she was admitted to the clinic, the pregnant woman was taken to the room with the turning and movement system, the system was introduced and the personal information form was filled.
When she came to the clinic from the operating room, the puerperant was placed on the bed with the turning and motion system (side position) and a follow-up form for LATCH, GKO and Lactogenesis Free symptoms was filled in the first three breastfeedings.
Before discharge, LATCH, GCS, and Lactogenesis symptoms follow-up forms were filled in the last three breastfeedings.
WHO was filled 1-2 hours before discharge.
On the 3rd and 4th days after discharge, the lactogenesis symptoms follow-up form was filled by phone.
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To provide effective breastfeeding by placing the mother in position.
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No Intervention: Control: Assigned Interventions standard care group
routine maintenance of the hospital
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time Frame: two day
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It is a randomized study planned as a research.
The sample of the study consists of postpartum women (75 experimental group, 75 control group) who had cesarean section.
Breastfeeding success of postpartum women was evaluated with the LATCH Breastfeeding Diagnosis and Evaluation tool.
This scale consists of five evaluation criteria (L:Latch on the brest, A: Audible Swallowing, T: Type of Nipple, C:Comfort of Breast/ Nipple, H: Hold/ Position).
Each item is evaluated between 0-2 points.
The scale has no breakpoints.
The highest score that can be obtained from the scale is 10 and the lowest score is 0.
An increase in the score obtained from the scale indicates the success of breastfeeding.
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two day
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The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time Frame: two days
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Postpartum pain was assessed with the Visual Comparison Scale.
Painlessness on one head and the most severe pain on the other side were evaluated with a 10 cm ruler.
An increase in the scale score indicates an increase in the severity of pain.
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two days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time Frame: one day
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Postpartum comfort of postpartum women was evaluated with the postpartum comfort scale.
The scale has no breakpoints.
The scale consists of 34 items.
The minimum score to be taken from the scale is 34 and the maximum score is 170.
The higher the score obtained from the scale, the higher the comfort.
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one day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: merve lazoglu, phd, Kars Harakani State Hospital
- Study Director: Serap Ejder Apay, Prof., Ataturk University Faculty of Health Sciences Department of Midwifery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KarsHarakani Lazoglu0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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