HysteroscopyNCT03111563
Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
A study testing Warm saline distension media in office hysteroscopy in people with Hysteroscopy, run by Ain Shams University.
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 . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysteroscopy
- What is being tested?
- Warm saline distension media in office hysteroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2017to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- History of vaginal pruritis, discharge, dysuria, dysmenorrhea, dyspareunia or chronic pelvic pain.
- Presence of pain, profuse bleeding or other symptoms at the time of the procedure.
- 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 .
- Need for cervical dilatation during procedure. m. Need for biopsy or any operative intervention during the procedure.
About this study
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 .
Read the 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
- Conditions
- Hysteroscopy
- Being tested
- Warm saline distension media in office hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm saline distension media in office hysteroscopyOther
warm saline distension media in office hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| warm saline | Other | case group , Receives: Other: Warm saline distension media in office hysteroscopy |
| room temperature | Other | control group Receives: Other: Warm saline distension media in office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
assesment of pain immediately at the end of the procedure and 15 minutes after it
- 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.
Measured: immediately after the procedure and 15 minutes after the end of it
Secondary outcomes (2)
patient satisfaction
Patients' satisfaction will be evaluated as the percentage of patients who would undergo the examination again using the same method
Measured: 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
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Apr 2017
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melad Eskander, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111563
- Sponsor's protocol ID
- WSDM
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Warm Saline Distension Media on Relieving Pain in Office Hysteroscopy
- ClinicalTrials.gov ID
- NCT03111563
- Acronym / sponsor ID
- WSDM
- Conditions
- Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| warm saline | Other | Other: Warm saline distension media in office hysteroscopycase group , |
| room temperature | Other | Other: Warm saline distension media in office hysteroscopycontrol group |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm saline distension media in office hysteroscopywarm saline distension media in office hysteroscopy | Other | room temperature, warm saline |
Primary outcome
assesment of pain immediately at the end of the procedure and 15 minutes after it
Time frame: immediately after the procedure and 15 minutes after the end of 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.
2 secondary outcomes
patient satisfaction
Time frame: during procedure
time taken to complete the procedure
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Warm saline distension media in office hysteroscopy in people with Hysteroscopy, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assesment of pain immediately at the end of the procedure and 15 minutes after it (time frame: immediately after the procedure and 15 minutes after the end of it). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.