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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Perineal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Black tea bag

Group Type EXPERIMENTAL

Warm water soaked Black Tea Bags

Intervention Type OTHER

warm water soaked black tea bags will be provided to participants' as per their request

ice packs

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

Group Type ACTIVE_COMPARATOR

Frozen perineal pad

Intervention Type OTHER

Frozen ice pads will be provided as per participants' request

Interventions

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Frozen perineal pad

Frozen ice pads will be provided as per participants' request

Intervention Type OTHER

Warm water soaked Black Tea Bags

warm water soaked black tea bags will be provided to participants' as per their request

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No