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临床试验/NCT05945095
NCT05945095Unknown不适用

The Effect of Chewing Gum After Cesarean Section on Gastrointestinal System Functions, Pain and Sleep Quality

Artvin Coruh University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2023年3月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

The study will be conducted on mothers who had planned cesarean section.After the birth, the information about the surgery in the personal information form will be completed. Then, mothers in the control group will be given standard postpartum care. The mothers in the experimental group, on the other hand, will chew sugar-free gum for at least 15 minutes, starting from the second hour after the surgery. The gum chewing process will be repeated every two hours. Mothers will be mobilized at the 8th sat after the birthday.

Pain levels of mothers in both groups will be evaluated every two hours after delivery.

In addition, the amount of analgesic use will be compared and comments will be made on the level of pain. The sleep quality of the postpartum women will be questioned the day after the cesarean section.

详细描述

The study will be conducted on mothers who had planned cesarean section. The sample size in similar studies was examined and it was determined that at least 30 mothers should be included in the experimental and control groups.

Assignment of pregnant women to the experimental and control groups will be made using a simple random numbers table.

In the data collection process of the research, the "personal information form" consisting of 24 questions and developed by the researchers as a result of the literature review, the "Richard-Campbell Sleep Scale" and the "Visual Comparison Scale (VAS)" will be used.

Prenatal interviews will be conducted with the pregnant women and their status of meeting the following inclusion criteria will be evaluated, and all pregnant women who comply with the criteria and agree to participate in the study will be asked questions regarding the prenatal period in the personal information form.

After the birth, the information about the surgery in the personal information form will be completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Be eighteen years of age or older,
  • Having a planned cesarean section,
  • To receive general anesthesia in the surgery,
  • No history of chronic constipation and diarrhea,
  • At least primary school graduate
  • Communication is not a problem.

排除标准

  • 未提供

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: "change" is being assessed. up to 10-12 hours after cesarean section

VAS is used to measure perceived pain. VAS is a 10cm line with anchor statements on lower end (no pain) and on upper end (extreme pain). The mother is asked to mark their current pain level on the line

次要结局

  • Richard-Campbell Sleep Scale (RCUI)(in the morning the day after the cesarean section)

研究者

发起方
Artvin Coruh University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Kaloglu Binici

Principal Investigator (PhD Research Nurse)

Artvin Coruh University

研究点 (2)

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