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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


NCT number NCT01626287
Study type Interventional
Source Fraser Health
Contact
Status Completed
Phase N/A
Start date November 2012
Completion date May 2013

See also
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Completed NCT05486624 - The Effect of Reiki Application on Episiotomy and Perineal Pain N/A