Improving Quality of LifeNCT02878135
Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion
A study testing fast application and slow application in people with Improving Quality of Life, run by Assiut University at 1 site in Egypt.
Trial summary
intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Improving Quality of Life
- What is being tested?
- fast application and slow application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Jun 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to intrauterine device insertion
- Women who will accept to participate in the study
Who cannot join
- Any contraindication to intrauterine device placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion
intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure
- Conditions
- Improving Quality of Life
- Being tested
- fast application, slow application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast applicationProcedure or surgery
slow applicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| fast vulsellum | Experimental | rapid ratchet of the vulsellum Receives: Procedure: fast application |
| slow vulsellum | Active comparator | Placement of the tenaculum over 7-10 seconds and not allowing the vulsellum to ratchet audibly. Receives: Procedure: slow application |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Pain score with vulsellum placement
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
- Investigators
- Ahmed Abbas, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878135
- Sponsor's protocol ID
- SLVOL
- Status last verified
- Jul 2017
- First submitted
- 22 Aug 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Slow Versus Fast Application of Vulsellum on Pain Perception During Intrauterine Device Insertion
- ClinicalTrials.gov ID
- NCT02878135
- Acronym / sponsor ID
- SLVOL
- Conditions
- Improving Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast vulsellum | Experimental | Procedure: fast applicationrapid ratchet of the vulsellum |
| slow vulsellum | Active comparator | Procedure: slow applicationPlacement of the tenaculum over 7-10 seconds and not allowing the vulsellum to ratchet audibly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women not taken analgesics or anxiolytics in the 24 hours prior insertion
- Women not taken misoprostol prior to intrauterine device insertion
- Women who will accept to participate in the study
Key exclusion criteria (1 listed)
- Any contraindication to intrauterine device placement
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 |
|---|---|---|
| fast application | Procedure or surgery | fast vulsellum |
| slow application | Procedure or surgery | slow vulsellum |
Primary outcome
mean Pain score with vulsellum placement
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: Yes
Related trials for Improving Quality of Life
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Recruiting
The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
Acute Myeloid Leukemia, Multiple Myeloma
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Not yet recruiting
Symptom Monitoring and Management Intervention After CAR-T
Chimeric Antigen Receptor T-cell Therapy, Hematologic Malignancy
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.
Ahmed Abbas, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast application and slow application in people with Improving Quality of Life, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
mean Pain score with vulsellum placement (time frame: 5 minutes). 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 1 Aug 2017.