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

May 22, 2015 updated by: Fraser Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Abbotsford, British Columbia, Canada
        • Abbotsford Regional Hospital and Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
use of analgesia during hospitalization
Time Frame: 24 hours post partum
24 hours post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Health

Investigators

  • Principal Investigator: Karmjit Kaur Sandhu, MScN, Fraser Health Authority

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (ESTIMATE)

June 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FHREB 2012-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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