Sitz bath for acute anal pain: cold or warm?
| ISRCTN | ISRCTN50105150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50105150 |
| Secondary identifying numbers | 001 |
- Submission date
- 27/11/2008
- Registration date
- 02/01/2009
- Last edited
- 29/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Parés
Scientific
Scientific
Hospital del Mar
Colorectal Surgery Unit
Passeig maritim 25 - 29
Barcelona
08003
Spain
Study information
| Study design | Randomised controlled, two-arm trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/01/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital del Mar
Barcelona
08003
Spain
08003
Spain
Sponsor information
Hospital del Mar (Spain)
Hospital/treatment centre
Hospital/treatment centre
Passseig Maritim 25 - 29
Barcelona
08003
Spain
| Website | http://www.hospitaldelmar.cat/ |
|---|---|
"ROR" |
https://ror.org/03a8gac78 |
Funders
Funder type
Hospital/treatment centre
Hospital del Mar (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2010 | Yes | No |
