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Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy

Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03111563
Enrollment
82
Registered
2017-04-13
Start date
2017-04-01
Completion date
2017-10-31
Last updated
2017-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy

Brief summary

The aim of the study is to compare the effectiveness of warm saline distension media versus room temperature saline distension media on relieving pain in office hysteroscopy .

Detailed description

Research hypothesis : In women undergoing diagnostic hysteroscopy, warm saline distension media may be effective in decreasing the pain during the procedure . Research question : In women undergoing diagnostic hysteroscopy, does warm saline distension media decrease the pain during the procedure ? Aim of the work : \- This study aim to assess the efficacy of warm saline distension media in decreasing the pain in women undergoing diagnostic hysteroscopy

Interventions

OTHERWarm saline distension media in office hysteroscopy

warm saline distension media in office hysteroscopy

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: 20-40 years old (premenopausal women ). 2. Normal cervical morphology during speculum examination. 3. Women complaining of abnormal uterine bleeding 4. Women underging the procedure to evaluate the endocervical canal, uterine cavity and tubal ostia because of infertility. 5. Suspected mullerian anomalies.

Exclusion criteria

* a. Pregnancy. b. Suspected acute pelvic inflammatory disease. c. Past history of medical disorders, especially associated with neuropathies, e.g. diabetes, chronic kidney disease, etc. d. History of vaginal pruritis, discharge, dysuria, dysmenorrhea, dyspareunia or chronic pelvic pain. e. Presence of pain, profuse bleeding or other symptoms at the time of the procedure. f. History of uterine surgery that occurred less than 1 month previously. g. History of previous cervical procedures. h. Administration of general, cervical or paracervical anesthesia. i. Administration of sedatives. j. Any use of analgesic agents before the procedure. k. Cervical preparation by misoprostol before procedure orally or vaginally for cervical ripening to improve the likelihood of successful cervical dilation and decrease intraoperative pain . l. Need for cervical dilatation during procedure. m. Need for biopsy or any operative intervention during the procedure.

Design outcomes

Primary

MeasureTime frameDescription
assesment of pain immediately at the end of the procedure and 15 minutes after itimmediately after the procedure and 15 minutes after the end of itd. The degree of pain that the patient feels in the procedure will be estimated by using visual analoge scale (VAS) (figure 1) at 2 times: At the end of the procedure and at 15 minutes after the examination. The patient makes a mark on the VAS line to indicate the intensity of her pain. The distance from the zero point to the marked point is measured using a graduated ruler. Each pain assessment is made on a separate line.

Secondary

MeasureTime frameDescription
patient satisfactionduring procedurePatients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method
time taken to complete the procedureduring procedureThe time taken to perform the examination is measured in minutes, from introduction from the cervix.of the hysteroscope into the vagina until removing it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026