Back to resultsEffectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
Primary Purpose
Hysteroscopy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Warm saline distension media in office hysteroscopy
Sponsored by
About this trial
This is an interventional prevention trial for Hysteroscopy
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
warm saline
room temperature
Arm Description
case group ,
control group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
patient satisfaction
Patients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03111563
Brief Title
Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
Official Title
Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
warm saline
Arm Type
Other
Arm Description
case group ,
Arm Title
room temperature
Arm Type
Other
Arm Description
control group
Intervention Type
Other
Intervention Name(s)
Warm saline distension media in office hysteroscopy
Intervention Description
warm saline distension media in office hysteroscopy
Primary Outcome Measure Information:
Title
assesment of pain immediately at the end of the procedure and 15 minutes after it
Description
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.
Time Frame
immediately after the procedure and 15 minutes after the end of it
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
Patients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method
Time Frame
during procedure
Title
time taken to complete the procedure
Description
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
Time Frame
during procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
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