ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01626287
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Fraser Health

June 20, 2012
June 22, 2012
May 25, 2015
November 2012
May 2013   (Final data collection date for primary outcome measure)
use of analgesia during hospitalization [ Time Frame: 24 hours post partum ]
Same as current
Complete list of historical versions of study NCT01626287 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
Not Provided

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Perineal Pain
  • 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
  • Experimental: Black tea bag
    Intervention: Other: Warm water soaked Black Tea Bags
  • Active Comparator: ice packs
    20 randomly chosen participants will be given frozen ice packs for perineal pain relief
    Intervention: Other: Frozen perineal pad
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
40
May 2013
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
19 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01626287
FHREB 2012-044
Yes
Not Provided
Not Provided
Fraser Health
Fraser Health
Not Provided
Principal Investigator: Karmjit Kaur Sandhu, MScN Fraser Health Authority
Fraser Health
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP