NCT05499208

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

August 8, 2022

Last Update Submit

September 27, 2022

Conditions

Keywords

painmidwifebreast-feedingmovementcomfort

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    two days

Secondary Outcomes (1)

  • The Effect of Turning and Movement System on Breastfeeding Success, Pain and Comfort in Postpartum Cesarean Section

    one day

Study Arms (2)

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.

Other: Giving side position with patient turning and movement system

Control: Assigned Interventions standard care group

NO INTERVENTION

routine maintenance of the hospital

Interventions

To provide effective breastfeeding by placing the mother in position.

Giving side position with patient turning and movement system

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kars Harakani State Hospital

Kars, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingPain

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • merve lazoglu, phd

    Kars Harakani State Hospital

    PRINCIPAL INVESTIGATOR
  • Serap Ejder Apay, Prof.

    Ataturk University Faculty of Health Sciences Department of Midwifery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 12, 2022

Study Start

December 1, 2020

Primary Completion

June 30, 2021

Study Completion

September 16, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

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Locations