Trials / Completed
CompletedNCT01626287
Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Fraser Health · Academic / Other
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Frozen perineal pad | Frozen ice pads will be provided as per participants' request |
| OTHER | Warm water soaked Black Tea Bags | warm water soaked black tea bags will be provided to participants' as per their request |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2012-06-22
- Last updated
- 2015-05-25
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01626287. Inclusion in this directory is not an endorsement.