Prospective randomised controlled trial of room temperature versus body temperature saline in outpatients hysteroscopy and pain scores
| ISRCTN | ISRCTN08546448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08546448 |
| Secondary identifying numbers | N0155126389 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Tandon
Scientific
Scientific
Obstetrics and Gynaecology
North Manchester General Hospital
Delaunays Road
Manchester
M8 5RB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective randomised controlled trial of room temperature versus body temperature saline in outpatients hysteroscopy and pain scores |
| Study objectives | Comparison of body temperature saline versus room temperature saline in outpatient hysteroscopy. Assessment of procedural discomfort using pain scores. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Hysteroscopy |
| Intervention | This is a pilot study comparing discomfort levels in two groups of patients undergoing hysteroscopy. In the one group, hysteroscopy will be performed in the clinic using room temperature saline to distend the uterine cavity (the existing method in use). In the second group saline warmed to body temperature is used. Discomfort levels are assessed in the two groups using pain scores. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Completion date | 30/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 50 |
| Key inclusion criteria | 50 outpatients |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 30/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Obstetrics and Gynaecology
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Pennine Acute Hospitals NHS Trust (UK)
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 |
Editorial Notes
18/10/2017: No publications found, study status unverified
