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

NCT ID: NCT03111563

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-10-31

Brief Summary

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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

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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

Conditions

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Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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warm saline

case group ,

Group Type OTHER

Warm saline distension media in office hysteroscopy

Intervention Type OTHER

warm saline distension media in office hysteroscopy

room temperature

control group

Group Type OTHER

Warm saline distension media in office hysteroscopy

Intervention Type OTHER

warm saline distension media in office hysteroscopy

Interventions

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Warm saline distension media in office hysteroscopy

warm saline distension media in office hysteroscopy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Melad Eskander

Sohag

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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WSDM

Identifier Type: -

Identifier Source: org_study_id

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