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临床试验/NCT05764512
NCT05764512已完成不适用

Endorphins Applied to Women Who Have Delivered Vaginally Effect of Massage on Pain

TC Erciyes University2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2023年2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
80
试验地点
2
主要终点
Serum Beta Endorphin Level

研究概览

简要总结

In this study, it is aimed to determine the effect of endorphin massage applied to puerperant women who had vaginal delivery on pain, comfort, mood and serum beta endorphin levels in the postpartum period.

详细描述

Massage application provides an increase in the level of endorphins by making a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relax the muscles and reduce pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones, providing a feeling of calmness and comfort. In addition to reducing pain, the endorphin hormone provides relaxation, supports the immune system, and accelerates metabolic activities. It is also known as the happiness hormone.

It is stated that back massage will increase the release of endorphin hormones by relaxing the mother. In other studies conducted in the postpartum period, it has been determined that massage applied reduces the severity of pain and stress, and increases the level of comfort.

Studies have shown that endorphin massage applied to pregnant women reduces back pain. In another study, it was determined that deep tissue massage applied to the back area after cesarean section reduced the level of pain. In the other study, it was determined that the endorphin massage applied to the 3rd trimester pregnant women reduced the level of anxiety.

When the literature is examined, no study has been found that examines the effect of endorphin massage applied to puerperant women on pain, comfort, mood and beta endorphin levels in the postpartum period. The fact that endorphin massage is applied to similar areas with both back massage and oxytocin massage suggests that endorphin massage may affect the pain process experienced in the postpartum period. It is aimed to determine the effect on endorphin level.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The blood samples are numbered by writing the names of the puerperant women. Nurses who care, the biochemist who analyzes the blood samples and the specialist who does the statistical analysis will not know the groups to which the puerperal puerperants are assigned. In the hospital where the research will be conducted, one of the two parts of the postpartum service is used for the intervention group and the other for the control group in order to prevent encounters between the intervention and control group.

入排标准

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

入选标准

  • Those who gave birth vaginally in their gestational week,
  • In the first 24 hours postpartum,
  • Primiparous,
  • Episiotomy applied,
  • Having a VAS value of at least 5 points,
  • Having given birth to a single baby,
  • Your baby's APGAR Score is between 7-10,
  • Skin-tissue integrity,
  • No communication problem,
  • The spoken language is Turkish,
  • Voluntary to participate in the study

排除标准

  • The baby was admitted to the neonatal intensive care unit,
  • Having a cesarean section,
  • Experiencing risky labor,
  • Postpartum bleeding,
  • Epidural analgesia applied
  • Having a psychiatric disease (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
  • Having chronic disease (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD),
  • Postpartum women diagnosed with risky pregnancy (Pre-eclampsia, Eclampsi, Pregnancy-related hypertension, Gestational diabetes, bleeding conditions during pregnancy)

结局指标

主要结局

Serum Beta Endorphin Level

时间窗: two hours

Blood samples are taken from the puerperal women by following the antiseptic rules, into a yellow-capped and gelled blood tube (3-4 mL) by the researcher. The blood tubes are kept at room temperature and in an upright position for 30 minutes. Samples sent to the laboratory are centrifuged at 4000 rpm for 10 minutes. The serum obtained after centrifugation is taken from the blood tubes, put into eppendorf tubes and stored frozen at -80 degrees.

Visual Analog Scale

时间窗: two hours

It is a commonly used scale to measure pain. It consists of a 10 cm ruler on which the patient marks the pain, showing that there is no pain at one end and unbearable pain at the other end. The distance between the point where the patient marked the pain and the pain-free interval is measured in cm and recorded. In addition, this scale is used to measure comfort. The VAS, which will be used to determine the level of comfort, consists of a ruler of 0 to 10 cm, as well as the level of pain. VAS; 0 = very comfortable, 10 = extremely uncomfortable. In the calculation of the comfort score, the distance between the place marked by the puerperant as "I am comfortable" and the place marked as "I am uncomfortable" is measured and recorded in cm. In this research, the Visual Analog Scale is used to measure both pain level and comfort level.

Brief Mood Introspection Scale

时间窗: two hours

In the 16-item scale, the items consist of the emotion adjective and aim to evaluate the current emotional state of the participants. By obtaining two types of scores with the scale, positive (8 items) and negative (8 items) mood levels of the participants are determined. High scores for both mood states indicate high positive or negative emotions. The highest score for both moods is 32 and the lowest score is 8.

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

Nurseli Soylu Erener

Research Assistant

TC Erciyes University

研究点 (2)

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