Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
Sitz bath for acute anal pain: cold or warm? A randomised controlled trial
Acronym
FRI.CA study
Study hypothesis
A warm sitz bath is better than a cold one to relieve acute anal pain.
Ethics approval
Received from the local medical ethics board on the 2nd February 2006 (ref: 2005/2203/I)
Study design
Randomised controlled, two-arm trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute anal pain from haemorrhoids or anal fissure
Intervention
Treatment with sitz bath every 12 hours during 7 days. Follow-up will be performed every day during the first 7 days of the study. Recommendations of temperature for sitz bath, diary record of temperature and pain (Visual Analogue Scale [VAS]) will be assessed.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain control, evaluated using the VAS during the first 7 days of the study.
Secondary outcome measures
Outcome of disease (haemorrhoids or fissure), measured during the first 7 days of the study.
Overall trial start date
01/01/2007
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients aged over 18 years, either sex
2. Acute anal pain for haemorrhoids or anal fissure
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. No acceptance
2. Previous anal surgery
Recruitment start date
01/01/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital del Mar
Barcelona
08003
Spain
Sponsor information
Organisation
Hospital del Mar (Spain)
Sponsor details
Passseig Maritim 25 - 29
Barcelona
08003
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital del Mar (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20580349 [in Spanish]
Publication citations
-
Maestre Y, Parés D, Salvans S, Ibáñez-Zafón I, Nve E, Pons MJ, Martínez-Casas I, Pascual M, Pera M, Grande L, [Cold or hot sitz baths in the emergency treatment of acute anal pain due to anorectal disease? Results of a randomised clinical trial]., Cir Esp, 2010, 88, 2, 97-102, doi: 10.1016/j.ciresp.2010.04.007.