Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
26/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S Tandon

ORCID ID

Contact details

Obstetrics and Gynaecology
North Manchester General Hospital
Delaunays Road
Manchester
M8 5RB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155126389

Study information

Scientific title

Prospective randomised controlled trial of room temperature versus body temperature saline in outpatients hysteroscopy and pain scores

Acronym

Study hypothesis

Comparison of body temperature saline versus room temperature saline in outpatient hysteroscopy. Assessment of procedural discomfort using pain scores.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

30/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

50 outpatients

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

50

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2004

Recruitment end date

30/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Obstetrics and Gynaecology
Manchester
M8 5RB
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Pennine Acute Hospitals NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes