跳至主要内容
临床试验/NCT01626287
NCT01626287已完成不适用

Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study

Fraser Health1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年11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
43
试验地点
1
主要终点
use of analgesia during hospitalization

研究概览

简要总结

Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a woman's recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications.

The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Investigator)

入排标准

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

入选标准

  • Primiparous women (delivering their first baby) over the age of 19 who have delivered vaginally at Abbotsford Regional Hospital and Cancer Centre

排除标准

  • multiparity (women who have delivered vaginally more than once), VBAC (Vaginal Birth after Cesarean Section), active sexually transmitted infection lesions, vulvar varicosities, third and forth degree perineal tear, hematoma, retained placenta/products, substance abuse, and other medical conditions requiring frequent analgesia

研究组 & 干预措施

Black tea bag

Experimental

干预措施: Warm water soaked Black Tea Bags (Other)

ice packs

Active Comparator

20 randomly chosen participants will be given frozen ice packs for perineal pain relief

干预措施: Frozen perineal pad (Other)

结局指标

主要结局

use of analgesia during hospitalization

时间窗: 24 hours post partum

次要结局

未报告次要终点

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Sponsor

研究点 (1)

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