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
Protocol serial number	N0155126389
Sponsor	Department of Health
Funder	Pennine Acute Hospitals NHS Trust (UK)

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

Dr S Tandon
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/07/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

Obstetrics and Gynaecology

Manchester
M8 5RB
United Kingdom

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

18/10/2017: No publications found, study status unverified