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临床试验/NCT06959940
NCT06959940已完成不适用

Alternative Method to Reduce Pain, Anxiety, Fatigue, and Thirst: Chewing Gum in Labor

Biruni University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
2

研究概览

简要总结

This study is a clinical trial. It aimed to examine the effects of chewing gum on pain, anxiety, fatigue, and thirst in pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women who gave birth vaginally; voluntarily accept to participate in the research. Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; whose baby dies during labor, who with cervical dilatation of 5 cm or more, who receiving epidural anesthesia, do not like chewing gum, have difficulty chewing, such as weak/loose-fitting dentures. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours until their dilatation reached 5 cm. Pregnant women in the experimental group chewed gum and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until their dilation reached 5 cm.

The main questions it aims to answer are:

  • Chewing gum during labor is not effective in reducing pain, anxiety, fatigue, and thirst levels.
  • Chewing gum during labor; It is effective in reducing the level of pain.
  • Chewing gum during labor; It is effective in reducing anxiety.
  • Chewing gum during labor; It is effective in reducing thirst.
  • Chewing gum during labor; It is effective in reducing fatigue. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group chewed gum also.

详细描述

Objective

In this study, it was aimed to examine the effects of chewing gum on pain, anxiety, fatigue and thirst in pregnant women in the first stage of normal labor.

Methods: The study was conducted in a randomized controlled experimental manner. The universe consisted of all pregnant women who applied to the delivery room of a public institution between April and November 2022. Power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. The study was started after the approval of the ethics committee and the institution. As a data collection tool in the research;"Personal Information Form","Gum Chewing Follow-up Form" and "Pregnant Follow-up Form" were used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Vaginal delivery,
  • •Who volunteered to participate in the research

排除标准

  • •Have auditory or mental health problems,
  • •The baby dies during labour,
  • •Cervical dilatation of 5 cm or more,
  • •Receiving epidural anaesthesia,
  • •People who don't like chewing gum,
  • •Chewing difficulties due to weak/loose prostheses

研究组 & 干预措施

This research is planned with experimental design

Experimental

After the pregnant woman in the control group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied. Pregnancy Follow-up Form consists of pain, anxiety, fatigue and thirst scales. The VAS pain, anxiety, fatigue, and thirst scales contains numbers evenly spaced (0-10) on a line. It is an evaluation scale filled out by patients stating their current pain, anxiety, fatigue, and thirst level by giving a number. The cut-off point of the VAS anxiety and thirst scales were found to be four. In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals. IN VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms.

干预措施: experimental group (gum group) (Other)

结局指标

主要结局

2

时间窗: Anxiety scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

Change from anxiety scale scores at control group or experimental group in during labor

1

时间窗: Pain scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

Change from pain scale scores at control group or experimental group in during labor

3

时间窗: Fatigue scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

Change from fatigue scale scores at control group or experimental group in during labor

4

时间窗: Thirst scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

Change from thirst scale scores at control group or experimental group in during labor

次要结局

未报告次要终点

研究者

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

Nilgun Avci

Assistant professor, PhD

Biruni University

研究点 (1)

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