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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fraser Health
ClinicalTrials.gov Identifier:
NCT01626287
First received: June 20, 2012
Last updated: October 28, 2013
Last verified: October 2013
  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)

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • use of analgesia during hospitalization [ Time Frame: 24 hours post partum ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: 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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626287

Locations
Canada, British Columbia
Abbotsford Regional Hospital and Cancer Centre
Abbotsford, British Columbia, Canada
Sponsors and Collaborators
Fraser Health
Investigators
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: October 28, 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 August 28, 2014