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临床试验/NCT05734885
NCT05734885已完成不适用

The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process

Selcuk University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Pregnant Introduction Form

研究概览

简要总结

H1-1 = There will be a difference between the pain levels of the partner massage group, midwife massage group, and control group following the massage application.

H1-2 = There will be a difference between the state anxiety levels of the partner massage group, midwife massage group, and control group following the massage application.

H1-3 = There will be a difference between the active phase durations of the partner massage group, midwife massage group, and control group following the massage application.

详细描述

Supporting the woman with massage during the labor process reduces the severity of pain, provides general relaxation and reduces anxiety. The application of spousal massage for supportive care to the woman during the labor process can provide important positive results in terms of providing both physical and emotional support. A positive perception of birth can be strengthened by meeting women's needs at a higher level. This may contribute to effective pain management, reduction of anxiety in women, improvement of birth outcomes and positive neonatal health outcomes. When the literature is examined, it has been determined that the scope and number of studies examining the effect of partner massage in labor on pain, anxiety and birth process is very limited, and there is no study on the subject in the national literature.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Those aged 20-35
  • Term pregnancies (those at 37-41 weeks of gestation)
  • Those with a single fetus
  • Primiparous
  • Those who do not have any risk factors during pregnancy (Preeclampsia, premature rupture of membranes, placental anomalies, macrosomic baby, etc.)
  • Those who do not have any chronic disease
  • Pregnant women who do not have skin disease, infection or varicose affecting the massage application.
  • Pregnant women with no deterioration in skin integrity
  • Those with cervical dilatation less than 4 cm
  • Those who are open to communication, mentally and mentally healthy
  • Those who agreed to participate in the study
  • Pregnant women with a spouse who agree to apply and apply massage for the spouse/partner massage group.

排除标准

  • Those who are in the active and transitional phase of labor
  • Abnormal changes in fetal heartbeats
  • Unexpected complication in pregnancy and fetus
  • Pregnant women who use pharmacological methods to reduce pain during labor
  • Pregnant women with contraindications for massage application (deterioration of skin integrity, varicose veins, skin disease and infection)
  • Pregnant women who are reluctant to continue participating in the research

结局指标

主要结局

Pregnant Introduction Form

时间窗: in active phase on labor (4 cm and less vaginal dilatation)

The pregnancy information form, which was prepared by the researcher following a literature review, consisted of 18 questions about some socio-demographic characteristics of pregnant women (age, education level, social security status, etc.) and their obstetric characteristics (gestational week, problems during pregnancy, etc.),

Labor Monitoring Form

时间窗: in labor and in the first 24 hours postpartum

This form was developed by the researcher following a literature review. It consisted of five items about the practices applied to pregnant women during labor (interventions applied during labor (forceps, vacuum, etc.)) and the characteristics of the newborn in the postpartum period (Apgar score, newborn weight, etc.),

Partograph

时间窗: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)

This is a tool used to assess the progress of labor and the health status of the fetus. It is used from the active phase of labor. It visualizes the progress of labor; cervical dilatation, the level of the fetal head, the frequency and duration of uterine contractions, fetal heart rate, the presence of amniotic membrane, and the color of amniotic fluid are evaluated and recorded on a graph paper Its central feature is a graph used to record the progress of cervical dilation, as determined by vaginal examination. Indicators are plotted on the graph each time they are checked: * Maternal indicators: * Time of spontaneous or artificial rupture of the membranes * Uterine contractions (number per 10 minutes and duration) * Drugs administered (oxytocin, antibiotics, etc.) * Foetal indicators: * Foetal heart rate * Amniotic fluid (colour, odour and quantity) * Descent of the foetal head and head moulding

Visual Analog Skala-VAS

时间窗: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)

The VAS was first developed by Price et al. (1983). The VAS is used to measure perceived pain. 10 cm, which says painlessness at one end and the most severe pain at the other end. On a (100 mm.) ruler, the patient describes his or her pain by drawing a line, pointing, or pointing. The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain.

Spielberger State Anxiety Scale

时间窗: in active phase on labor (4, 5-6, 8-9 cm vaginal dilatation)

It was developed by Spielberg et al in 1970. It was adapted into Turkish by Öner and Le Compte in 1983 (Öner \& Le Compte, 1983; Özusta, 1995). The state anxiety scale is a scale that determines how an individual feels at a particular moment and situation. It requires the individual to answer the feelings or behaviors he/she experiences in his/her situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely. The state anxiety scale consists of 20 statements. The score obtained from the scale can vary between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. In the scoring made in accordance with the criteria directive, 0-19 points are evaluated as "absent", 20-39 points as "mild", 40-59 points as "moderate", 60-79 points as "severe" and 80 points as severe anxiety (Dönmez, Yeniel, \& Kavlak, 2014).

Assessment of Satisfaction Scale

时间窗: in the first 24 hours postpartum

This scale was adopted by the researcher from the "Visual Analog Scale (VAS)", which individuals can easily understand \[35\]. The VAS helps measure some variables numerically, which is not possible otherwise. This scale was used to evaluate the satisfaction of the women in the study group with the massage application and the labor process. The numbers between 0 and 10, which were intended to indicate the point corresponding to the satisfaction status, were placed on a vertical line. A score of 0 on the scale indicated "not satisfied at all", while a score of 10 indicated "very satisfied."

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Nur Atas

Principal Investigator

Selcuk University

研究点 (1)

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