Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Perineal Pain |
Other: Frozen perineal pad Other: Warm water soaked Black Tea Bags |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) |
- use of analgesia during hospitalization [ Time Frame: 24 hours post partum ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ice packs
20 randomly chosen participants will be given frozen ice packs for perineal pain relief
|
Other: Frozen perineal pad
Frozen ice pads will be provided as per participants' request
|
| Experimental: Black tea bag |
Other: Warm water soaked Black Tea Bags
warm water soaked black tea bags will be provided to participants' as per their request
|
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Mildred Janzen | 604-851-4817 | mildred.janzen@fraserhealth.ca |
| Contact: Catherine A Burns, BScN | 604-851-4817 | catherine.burns@fraserhealth.ca |
| Canada, British Columbia | |
| Abbotsford Regional Hospital and Cancer Centre | Recruiting |
| Abbotsford, British Columbia, Canada | |
| Contact: Catherine A Burns, BScN 604-851-4817 catherine.burns@fraserhealth.ca | |
| Principal Investigator: | Karmjit Kaur Sandhu, MScN | Fraser Health Authority |
More Information
No publications provided
| Responsible Party: | Fraser Health |
| ClinicalTrials.gov Identifier: | NCT01626287 History of Changes |
| Other Study ID Numbers: | FHREB 2012-044 |
| Study First Received: | June 20, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Fraser Health:
|
perineal postpartum pain |
treatment ice and black tea maternal satisfaction |
ClinicalTrials.gov processed this record on May 23, 2013