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

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 .

Study Overview

• Status: Unknown
• Conditions: Hysteroscopy
• Intervention / Treatment: Other: Warm saline distension media 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

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: warm saline; case group ,	Other: Warm saline distension media in office hysteroscopy; warm saline distension media in office hysteroscopy
Other: room temperature; control group	Other: Warm saline distension media in office hysteroscopy; warm saline distension media in office hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	Patients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method	during procedure
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: WSDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No