Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline as distention medium.
| ISRCTN | ISRCTN56764412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56764412 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/06/2015
- Registration date
- 24/07/2015
- Last edited
- 24/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
A hysteroscopy is a procedure used to examine the inside of the uterus. It is an established diagnostic tool. One of the main causes of procedure failure is patient discomfort and pain. We do not know what the best way of reducing pain is. The aim of this study is to compare a warm normal saline distension solution versus a standard room-temperature normal saline.
Who can participate?
Women referred for outpatient hysteroscopy between January 2013 and June 2015.
What does the study involve?
Participants are allocated to one of two groups: one group receiving a sterile 0.9% normal saline warmed up to 32 degrees C as distention medium or another group receiving a room temperature sterile 0.9% normal saline solution. No pre medication or anaesthetics procedure used.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obstetrics and Gynaecology (Poland)
When is the study starting and how long is it expected to run for?
January 2015 to July 2015
Who is funding the study?
Central Clinical Hospital of Ministry of the Interior in Warsaw (CSK MSW) Department Obstetrics and Gynaecology (Poland)
Who is the main contact?
Tadeusz Issat
Contact information
Scientific
CSK MSW, Woloska 137
Warsaw
02-507
Poland
Study information
| Study design | Prospective randomized single center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A prospective randomized study for pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline as distention medium. |
| Study objectives | To assess the efficacy of warm normal saline distension solution versus a standard, room-temperature normal saline as distension medium for the pain relief during outpatient hysteroscopy. |
| Ethics approval(s) | Ethics Board and Control of Research trials on Humans and Animals in CSK MSW Warsaw, 01/07/2012, ref 73/2012 |
| Health condition(s) or problem(s) studied | Outpatient hysteroscopy |
| Intervention | Office hysteroscopy with warm normal saline distension solution or a standard room temperature normal saline distension medium |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Visual analogue scale (VAS) score during, 5 minutes and 15 minutes after the procedure. Median VAS scores during and directly after the anaesthesia-free hysteroscopy. |
| Secondary outcome measures | Side effects, complications failure rate, procedure time and the pain level during each stage of procedure. |
| Overall study start date | 01/01/2014 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | All patients aged over 18 years referred for hysteroscopy for diagnosis of abnormal endometrium on ultrasound, endometrial polyps and uterine bleeding were included in the study. All participants had a pelvic ultrasound examination to confirm the initial diagnosis. |
| Key exclusion criteria | Women with a possible pregnancy, lower genital tract infections, gestational trophoblastic disease, presence of endocervical polyps visualized on a speculum examination, asthma, acute porphyria, hepatitis, renal failure, lactation and oversensitivity to one of the agents or their elements were excluded. Patients with endometrial polyps measuring more than 30mm were excluded and referred for operative hysteroscopy under anesthesia. |
| Date of first enrolment | 01/01/2015 |
| Date of final enrolment | 20/06/2015 |
Locations
Countries of recruitment
- Poland
Study participating centre
02-507
Poland
Sponsor information
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Woloska 137
Warsaw
02/507
Poland
"ROR" |
https://ror.org/03b45mr48 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication in peer reviewed journal focused on minimally invasive gynaecology. Publication of the results and conclusion after finalizing the analysis in around 2 months. |
| IPD sharing plan |
