Fast Versus Slow Tenaculum Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-11

Study Completion Date

2017-03-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to investigate whether the speed of tenaculum placement affects perceived patient pain during office transcervical procedures.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pain Perception With Tenaculum Placement

NCT02969421

Pain

COMPLETED NA

Novel Cervical Retraction Device

NCT02283463

Pain Due to Certain Specified Procedures

UNKNOWN NA

Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures

NCT06193590

Intrauterine Device (IUD) Abnormal Uterine Bleeding

COMPLETED NA

Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

NCT07290517

IUD Abnormal Uterine Bleeding Pain, Cervical

NOT_YET_RECRUITING NA

Simplified IUD Insertion Technique

NCT02733081

Contraception

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

IUD insertion and endometrial biopsies are commonly performed in office procedures that use a tenaculum to stabilize the cervix. Patient's often complain that tenaculum placement is one of the most uncomfortable parts of these procedures. Patient's who agree to be in the study will be randomized into one of two groups, either slow tenaculum placement or fast tenaculum placement. Throughout the procedure patient's will be asked to rate the amount of pain they are experiencing using a visual analog scale. The researchers will then compare the two groups. The providers will also rate what they perceived the patient's pain to be with the procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

IUD Insertion Complication Endometrial Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fast placement

Placement of the tenaculum quickly and without avoiding ratchet

Group Type NO_INTERVENTION

No interventions assigned to this group

Slow placement of the tenaculum

Placement of the tenaculum over a 7-10 second time frame and not allowing the tenaculum to ratchet audibly.

Group Type EXPERIMENTAL

Slow placement of the tenaculum

Intervention Type PROCEDURE

Slow placement of the tenaculum on the cervix

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Slow placement of the tenaculum

Slow placement of the tenaculum on the cervix

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years old and older
* Clinic provider plans a transcervical procedure (IUD placement or endometrial biopsy)
* English speaking and able to consent