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

Not Applicable

Completed

• Conditions: Perineal Pain
• Interventions: Other: Frozen perineal pad; Other: Warm water soaked Black Tea Bags

• Registration Number: NCT01626287
• Lead Sponsor: Fraser Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-10
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ice packs	Frozen perineal pad	20 randomly chosen participants will be given frozen ice packs for perineal pain relief
Black tea bag	Warm water soaked Black Tea Bags	-

Primary Outcome Measures

Name	Time	Method
use of analgesia during hospitalization	24 hours post partum

Trial Locations

Locations (1)

Abbotsford Regional Hospital and Cancer Centre; 🇨🇦 Abbotsford, British Columbia, Canada