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

Tracking Information
First Submitted Date ICMJE	June 20, 2012
First Posted Date ICMJE	June 22, 2012
Last Update Posted Date	May 25, 2015
Study Start Date ICMJE	November 2012
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 21, 2012)	use of analgesia during hospitalization [ Time Frame: 24 hours post partum ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01626287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
Official Title ICMJE	Not Provided
Brief 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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator)
Condition ICMJE	Perineal Pain
Intervention ICMJE	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
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 28, 2013)	43
Original Estimated Enrollment ICMJE; (submitted: June 21, 2012)	40
Actual Study Completion Date	May 2013
Actual Primary Completion Date	May 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: Female
Ages	19 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01626287
Other Study ID Numbers ICMJE	FHREB 2012-044
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Fraser Health
Study Sponsor ICMJE	Fraser Health
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Karmjit Kaur Sandhu, MScN Fraser Health Authority
PRS Account	Fraser Health
Verification Date	October 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP