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

Study Overview
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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.

Conditions
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Perineal Pain

Intervention / Treatment
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* Other: Frozen perineal pad
* Other: Warm water soaked Black Tea Bags


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black tea bag<br> | Other: Warm water soaked Black Tea Bags<br>* warm water soaked black tea bags will be provided to participants' as per their request<br>|
| Active Comparator: ice packs<br>20 randomly chosen participants will be given frozen ice packs for perineal pain relief | Other: Frozen perineal pad<br>* Frozen ice pads will be provided as per participants' request<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of analgesia during hospitalization |  | 24 hours post partum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal, postpartum, pain, treatment, ice and black tea, maternal satisfaction