ClinicalTrials.gg
Not yet recruitingNCT07773376Updated Aug 19, 2026

Warm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial

An interventional study of Warmed Saline at 37 degrees celsius and Room-Temperature Normal Saline in Pain During Outpatient Hysteroscopy and Pain Reduction in Outpatient Hysteroscopy, sponsored by Reem Mohamed. Not yet recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Reem Mohamed · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 299 studies in Pain with a site in Egypt — 64 open to participants now, 79 under way, 5 of them phase 3. Pain · Egypt.

Planned enrollment
144th of 285
60 · median 62
Started
2026
with 25 others
No phase
189 of 299
52 open now
Primary completion
2026-12
later than 64 of 78 live
Registered
292nd of 299
by date

Among the 299 studies in Pain with a site in Egypt, this one is the 144th largest by planned enrollment of the 285 interventional ones that give a count, is one of 26 that started in 2026, is one of 189 with no phase, reaches primary completion later than 64 of the 78 other live ones, and was the 292nd registered.

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Open to participants now

64 of the 299 studies in Pain with a site in Egypt are open now.

All 64 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.

This study: 18 Years to 70 Years · female · healthy volunteers too.

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02

Study summary

The goal of this randomized clinical trial is to determine whether using warmed saline at 37°C during outpatient diagnostic hysteroscopy can reduce pain compared with room-temperature saline. The study will include women aged 18 to 70 years who are undergoing outpatient diagnostic hysteroscopy. Participants will be randomly assigned to receive either warmed saline at 37°C or room-temperature saline as the fluid used to expand the uterine cavity during the procedure. Data collected will then be used to compare pain scores between the two groups during hysteroscopy and one hour after the procedure. The study will also assess whether participants require additional pain medication and whether the procedure is stopped because of severe pain. The main hypothesis is that warmed saline at 37°C will result in lower pain scores than room-temperature saline.

Read the detailed description

Outpatient diagnostic hysteroscopy is commonly performed for the evaluation of intrauterine abnormalities and other gynecological indications. Pain during hysteroscopy may be influenced by cervical manipulation, uterine distension, and uterine contractions. The temperature of the distension medium may influence patient discomfort during the procedure.

This study is a parallel-group superiority randomized controlled trial designed to compare warmed normal saline at 37°C with room-temperature normal saline as the uterine distension medium during outpatient diagnostic hysteroscopy.

Eligible participants will be women aged 18 to 70 years who are scheduled for outpatient diagnostic hysteroscopy and who are able to understand and report pain using a visual analog scale. Participants will provide written informed consent before enrollment.

A total of 60 participants will be randomized in a 1:1 ratio to one of two study groups. The intervention group will undergo hysteroscopy using normal saline warmed to 37°C. The comparison group will undergo hysteroscopy using normal saline at room temperature. The temperature of the saline will be monitored using an infrared thermometer.

Pain intensity during the hysteroscopy will be assessed using a 0-to-10 visual analog scale and will constitute the primary outcome of the study. Secondary outcomes will include pain intensity one hour after the procedure, the need for additional analgesia during or after the procedure, and the proportion of participants in whom the procedure is abandoned because of intolerable pain.

The study will be conducted in the outpatient Endoscopy Unit of Demerdash Maternity Hospital, Ain Shams University. Diagnostic hysteroscopy will be performed using a 5-mm Karl Storz hysteroscope by the same senior physician.

The study is designed to determine whether the use of warmed saline at 37°C provides a clinically meaningful reduction in pain compared with room-temperature saline during outpatient diagnostic hysteroscopy.

03

Conditions studied

  • Pain During Outpatient Hysteroscopy
  • Pain Reduction in Outpatient Hysteroscopy

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Keywords

  • Outpatient hysteroscopy
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-70 years.
  • Ability to understand and report pain using the Visual Analog Scale.
  • Willingness to undergo outpatient hysteroscopy and provide written .

Exclusion criteria

Exclusion Criteria:

  • Congenital genital tract malformations: including these patients could introduce a confounding factor because pain may result from difficult anatomy rather than the temperature of the distension medium.
  • Previous hysteroscopic procedures: pain perception may be influenced by prior experience rather than the intervention itself
  • Suspected pregnancy: standard gynecologic practice considers pregnancy a to elective diagnostic hysteroscopy
  • Active pelvic infection: instrumentation of an infected genital tract may increase morbidity and facilitate ascending infection. Also, pain scores may reflect infection-related pain rather than procedural pain.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Warmed saline at 37 degrees celsius

    Participants randomized to this arm will undergo outpatient diagnostic hysteroscopy using normal saline warmed to 37°C as the uterine distension medium. The planned allocation is 30 participants.

    Other: Warmed Saline at 37 degrees celsius

  • Active comparator
    Room-Temperature Saline

    Participants randomized to this arm will undergo outpatient diagnostic hysteroscopy using normal saline at room temperature as the uterine distension medium. The planned allocation is 30 participants.

    Other: Room-Temperature Normal Saline

Interventions

  • OtherWarmed Saline at 37 degrees celsius

    Normal saline warmed to 37°C and used as the uterine distension medium during outpatient diagnostic hysteroscopy. The temperature of the saline will be monitored using an infrared thermometer before and during the procedure.

  • OtherRoom-Temperature Normal Saline

    Normal saline at room temperature used as the uterine distension medium during outpatient diagnostic hysteroscopy.

06

What researchers measure

Primary outcomes

  1. Pain intensity during outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS)

    Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. The VAS score recorded immediately after the hysteroscopy will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline.

    Time frame: During the hysteroscopy procedure

Secondary outcomes

  1. Pain intensity one hour after outpatient diagnostic hysteroscopy measured using the Visual Analog Scale (VAS)

    Pain intensity will be assessed one hour after completion of the hysteroscopy using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable. VAS pain scores will be compared between participants receiving warmed normal saline at 37°C and those receiving room-temperature normal saline.

    Time frame: 1 hour after completion of the hysteroscopy

  2. Need for additional analgesia after outpatient diagnostic hysteroscopy

    The need for additional analgesia will be recorded as a binary outcome according to whether the participant requires analgesic medication. The proportion of participants requiring additional analgesia will be compared between the warmed saline at 37°C group and the room-temperature saline group.

    Time frame: 1 hour after completion of the procedure

  3. Proportion of procedures abandoned due to intolerable pain

    The proportion of participants in whom outpatient diagnostic hysteroscopy is abandoned because of intolerable pain will be recorded and compared between the warmed saline at 37°C group and the room-temperature saline group.

    Time frame: During the hysteroscopy procedure

07

Study locations

1 site
08

References and documents

Publications

  • Tawfek ME, Hemeda HM, Ibrahim MA. Effectiveness of warm saline distension media on relieving pain in outpatient office hysteroscopy: a randomized controlled clinical trial. Journal of Gynecology & Reproductive Medicine. 2019;3(1):1-7.
  • De Silva PM, Smith PP, Cooper NAM, Clark TJ; Royal College of Obstetricians and Gynaecologists. Outpatient Hysteroscopy: (Green-top Guideline no. 59). BJOG. 2024 Dec;131(13):e86-e110. doi: 10.1111/1471-0528.17907. Epub 2024 Aug 19. PubMed 39160077 ↗
  • Kapur S, Gruber A, Sekar H, Mafuta J, Lodhi W, Sivashanmugarajan V, Yoong W. Does temperature of distending medium matter in outpatient hysteroscopy? A double-blinded cohort control observational study of room temperature versus warmed saline. J Obstet Gynaecol Res. 2020 Mar;46(3):485-489. doi: 10.1111/jog.14207. Epub 2020 Jan 28. PubMed 31991520 ↗
  • Issat T, Beta J, Nowicka MA, Durczynski A, Jakimiuk AJ. Pain assessment during outpatient hysteroscopy using room temperature versus warm normal saline solution as a distention medium - a prospective randomized study. Clin Exp Obstet Gynecol. 2017;44(3):359-363. PubMed 29949273 ↗
  • Evangelista A, Oliveira MA, Crispi CP, Lamblet MF, Raymundo TS, Santos LC. Diagnostic hysteroscopy using liquid distention medium: comparison of pain with warmed saline solution vs room-temperature saline solution. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):104-7. doi: 10.1016/j.jmig.2010.09.009. PubMed 21195961 ↗
  • Nair VG, Mahajan R, Aziz A, Tiwari S. Effectiveness of warm saline for pain relief in office hysteroscopy: a prospective randomized control trial. International Journal of Clinical Obstetrics and Gynaecology. 2020;4(4):85-88. DOI: 10.33545/gynae.2020.v4.i4b.628.
  • Baradwan S, Khalil M, Alshahrani MS, Albouq B, AlSghan R, Khadawardi K, Mohamed DF, Yousef DH, Kamal SHM, Abdel Halim HW, Elhawary MAA, Alkholy EA, Elsharkawy MRM, Abdelhakim AM, Abbas AM, Dahshan SA, Alshawadfy A, Soror GI. Warm saline effectiveness for pain relief in office hysteroscopy: A systematic review and meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2022 Jul;48(7):1523-1530. doi: 10.1111/jog.15272. Epub 2022 Apr 24. PubMed 35466496 ↗
  • Abdallah KS, Gadalla MA, Breijer M, Mol BWJ. Uterine distension media for outpatient hysteroscopy. Cochrane Database Syst Rev. 2021 Nov 26;11(11):CD006604. doi: 10.1002/14651858.CD006604.pub2. PubMed 34826139 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 3 months is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2026
First posted
Aug 19, 2026
StartEst.
Sep 2026
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07773376
Lead sponsor
Reem Mohamed
Responsible party
Reem Mohamed (Resident Physician, Ain Shams University) — Sponsor-investigator
First posted
Aug 19, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 19, 2026

Study contacts

Reem M Sadiq, MBBCh
Contact
reem_mohamed@med.asu.edu.eg
+201113939778

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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