Sitz bath for acute anal pain: cold or warm?

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David Parés
Scientific

Hospital del Mar
Colorectal Surgery Unit
Passeig maritim 25 - 29
Barcelona
08003
Spain

Primary study design	Interventional
Study design	Randomised controlled, two-arm trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Sitz bath for acute anal pain: cold or warm? A randomised controlled trial
Study acronym	FRI.CA study
Study objectives	A warm sitz bath is better than a cold one to relieve acute anal pain.
Ethics approval(s)	Received from the local medical ethics board on the 2nd February 2006 (ref: 2005/2203/I)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Pain control, evaluated using the VAS during the first 7 days of the study.
Key secondary outcome measure(s)	Outcome of disease (haemorrhoids or fissure), measured during the first 7 days of the study.
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Adult patients aged over 18 years, either sex 2. Acute anal pain for haemorrhoids or anal fissure 3. Written informed consent
Key exclusion criteria	1. No acceptance 2. Previous anal surgery
Date of first enrolment	01/01/2007
Date of final enrolment	31/12/2008

Hospital del Mar

Barcelona
08003
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes