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

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03111563
• Other study ID #: WSDM
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2017
• Last updated: April 7, 2017
• Start date: April 1, 2017
• Est. completion date: October 2017

Study information

• Verified date: April 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

Other:
• Warm saline distension media in office hysteroscopy
warm saline distension media in office hysteroscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	patient satisfaction	Patients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method	during procedure
Secondary	time taken to complete the procedure	The time taken to perform the examination is measured in minutes, from introduction from the cervix.of the hysteroscope into the vagina until removing it	during procedure