Pain UterusNCT03279666
Biopsy Size and Pain Perception During Colposcopic Biopsy
A study testing Tenaculum replacement in people with Pain Uterus and Tenaculum, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain Uterus, Tenaculum
- What is being tested?
- Tenaculum replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2017to 31 Dec 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 year-old women who had colposcopic biopsy
Who cannot join
- Had orthopedical problems
- Analgesic allergy
- Have previous cone biopsy
- Analgesic use until six hours before colposcopy
- Advanced cervicovaginal atrophy
- Linear Visual Analog Score for pain is used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy
The investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.
Read the detailed description
The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.
- Conditions
- Pain Uterus, Tenaculum
- Being tested
- Tenaculum replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenaculum replacementOther
Tenaculum replacement during colposcopic biopsy
| Study group | Role | What they receive |
|---|---|---|
| tenaculum with intracervical blockage | Active comparator | Not described Receives: Other: Tenaculum replacement |
| No tenaculum with intracercical blockage | No intervention | Not described |
| Tenaculum without intracervical blockage | Active comparator | Not described Receives: Other: Tenaculum replacement |
| No Tenaculum without intracervical blockage | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Biopsy Sizes
Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.
Measured: 6 months
Patients' Biopsy Sizes
Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.
Measured: 6 months
Secondary outcomes (2)
Patients' pain perceptions
Are patients' pain perceptions associate with analgesic. Linear Visual Analog Scale will be used for pain perception.
Measured: 6 months analgesic
Patients' pain perceptions
Are patients' pain perceptions associate with teanaculum. Linear Visual Analog Scale will be used for pain perception.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start15 Jun 2017
- Primary completion30 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain UterusStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279666
- Sponsor's protocol ID
- 2017/47
- Status last verified
- Jun 2018
- First submitted
- 16 Aug 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Comba C, Demirayak G, Erdogan SV, Karaca I, Demir O, Guler O, Ozdemir IA. Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial. Obstet Gynecol Sci. 2020 Jul;63(4):506-513. doi: 10.5468/ogs.19185. Epub 2020 Jun 19.
PubMed 32550738
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study: Patients' With or Without Tenaculum Placement and Intracervical Blockage/or Not During Colposcopic Biopsy
- ClinicalTrials.gov ID
- NCT03279666
- Acronym / sponsor ID
- 2017/47
- Conditions
- Pain Uterus, Tenaculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 12 Sep 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 investigators will investigate patients pain and biopsy size during colposcopic biopsy. The investigators will use tenaculum randomized patient with or without intracervical blockage.
Detailed description
The study was designed four arms. The investigators will perform colposcopy because of various causes. The first arm is used tenaculum and performed intracervical blockage. The second arm is not used tenaculum and performed intracervical blockage. The third arm is used tenaculum and not performed intracervical blockage. The fourth arm is not used tenaculum and not performed intracervical blockage and then we will study patients pain and biopsy size during colposcopic biopsy. Pain reduce and biopsy size are very important for patient and diagnose of the cervix cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tenaculum with intracervical blockage | Active comparator | Other: Tenaculum replacement |
| No tenaculum with intracercical blockage | No intervention | – |
| Tenaculum without intracervical blockage | Active comparator | Other: Tenaculum replacement |
| No Tenaculum without intracervical blockage | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 year-old women who had colposcopic biopsy
Key exclusion criteria (6 listed)
- Had orthopedical problems
- Analgesic allergy
- Have previous cone biopsy
- Analgesic use until six hours before colposcopy
- Advanced cervicovaginal atrophy
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 |
|---|---|---|
| Tenaculum replacementTenaculum replacement during colposcopic biopsy | Other | Tenaculum without intracervical blockage, tenaculum with intracervical blockage |
Primary outcome
Patients' Biopsy Sizes
Time frame: 6 months
Are patients' biopsy sizes associate with tenaculum. Milimeter will be used for biopsy size.
Patients' Biopsy Sizes
Time frame: 6 months
Are patients' biopsy sizes associate with analgesic. Milimeter will be used for biopsy size.
2 secondary outcomes
Patients' pain perceptions
Time frame: 6 months analgesic
Patients' pain perceptions
Time frame: 6 months
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 8 Jun 2018.
- Derived from this study: PubMed 32550738Comba C, Demirayak G, Erdogan SV, Karaca I, Demir O, Guler O, Ozdemir IA. Comparison of pain and proper sample status according to usage of tenaculum and analgesia: a randomized clinical trial. Obstet Gynecol Sci. 2020 Jul;63(4):506-513. doi: 10.5468/ogs.19185. Epub 2020 Jun 19.
Related trials for Pain Uterus
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Recruiting
Ameliorated Pap Tests and Cervical Cancer Screening Participation
Cervical Cancer Screening, Cervical Cancer Screening Methods
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenaculum replacement in people with Pain Uterus and Tenaculum, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 6 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 8 Jun 2018. 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 Turkey (Türkiye). 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?
Patients' Biopsy Sizes (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279666, which also lists 1 linked publication.
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 8 Jun 2018.