Breast Feeding, ExclusiveRotationNCT05499208
Rotation and Movement System, Postpartum Cesarean Sections
A study testing Giving side position with patient turning and movement system in people with Breast Feeding, Exclusive, run by Kars Harakani State Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive
- What is being tested?
- Giving side position with patient turning and movement system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 16 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
While studies on the Patient Turning and Movement System have been conducted on long-term bedridden patients, there is no scientific study examining its effects in the obstetric field. For the reasons mentioned above, the aim of this research is; The aim of this study is to investigate the effect of Patient Turning and Movement System on postpartum early postpartum breastfeeding success, pain and postpartum comfort in puerperant women who delivered by cesarean section and to contribute to the literature.
- Conditions
- Breast Feeding, Exclusive
- Being tested
- Giving side position with patient turning and movement system
- Keywords
- pain, midwife, breast-feeding, movement, comfort
- Medical subject headings
- Breast Feeding, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving side position with patient turning and movement systemOther
To provide effective breastfeeding by placing the mother in position.
| Study group | Role | What they receive |
|---|---|---|
| Giving side position with patient turning and movement system | Experimental | 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. Receives: Other: Giving side position with patient turning and movement system |
| Control: Assigned Interventions standard care group | No intervention | routine maintenance of the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
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.
Measured: two day
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
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.
Measured: two days
Secondary outcomes (1)
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars Harakani State Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Merve Lazoğlu, Kars Harakani State Hospital
- Investigators
- merve lazoglu, phd, Principal investigator, Kars Harakani State HospitalSerap Ejder Apay, Prof., Study director, Ataturk University Faculty of Health Sciences Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499208
- Sponsor's protocol ID
- KarsHarakani Lazoglu0001
- Acronym
- Rotation
- Status last verified
- Sep 2022
- First submitted
- 8 Aug 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: bireysel katılımcı verilerini diğer araştırmacılarla paylaşmıyoruz
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
- ClinicalTrials.gov ID
- NCT05499208
- Acronym / sponsor ID
- Rotation / KarsHarakani Lazoglu0001
- Conditions
- Breast Feeding, Exclusive
- Keywords
- pain, midwife, breast-feeding, movement, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kars Harakani State HospitalUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 12 Aug 2022 (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.
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.
Detailed description
While studies on the Patient Turning and Movement System have been conducted on long-term bedridden patients, there is no scientific study examining its effects in the obstetric field. For the reasons mentioned above, the aim of this research is; The aim of this study is to investigate the effect of Patient Turning and Movement System on postpartum early postpartum breastfeeding success, pain and postpartum comfort in puerperant women who delivered by cesarean section and to contribute to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giving side position with patient turning and movement system | Experimental | Other: Giving side position with patient turning and movement systemOn 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. |
| Control: Assigned Interventions standard care group | No intervention | –routine maintenance of the hospital |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between the ages of 18-35.
- Primiparity.
- Having a transverse cesarean section.
- At least primary school graduate.
- No high-risk pregnancy.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Giving side position with patient turning and movement systemTo provide effective breastfeeding by placing the mother in position. | Other | Giving side position with patient turning and movement system |
Primary outcome
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time frame: two day
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.
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time frame: two days
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.
1 secondary outcome
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. bireysel katılımcı verilerini diğer araştırmacılarla paylaşmıyoruz
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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. This study is not recruiting at the moment.
merve lazoglu, phd principal investigator
Kars Harakani State Hospital
Serap Ejder Apay, Prof. study director
Ataturk University Faculty of Health Sciences Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giving side position with patient turning and movement system in people with Breast Feeding, Exclusive, run by Kars Harakani State Hospital 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 6 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: finished, as of the sponsor's last update on 28 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section (time frame: two day). The study lists 2 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 28 Sep 2022.