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

NCT03111563 | Unknown DMC

• 1 other identifier: WSDM
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• assesment of pain immediately at the end of the procedure and 15 minutes after it

  d. 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.

  immediately after the procedure and 15 minutes after the end of it

Secondary Outcomes (2)

• patient satisfaction

  during procedure

• time taken to complete the procedure

  during procedure

Study Arms (2)

warm saline

OTHER

case group ,

Other: Warm saline distension media in office hysteroscopy

room temperature

OTHER

control group

Other: Warm saline distension media in office hysteroscopy

Interventions

Warm saline distension media in office hysteroscopy OTHER

warm saline distension media in office hysteroscopy

room temperature; warm saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sohag

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 13, 2017
• Study Start: April 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share