Fast Versus Slow Tenaculum Placement

Abbey Hardy-Fairbanks

Status: Completed

Conditions: IUD Insertion Complication; Endometrial Diseases

Treatments: Procedure: Slow placement of the tenaculum

Study type: Interventional

Funder types: Other

Identifiers

NCT02716636

201509756

Details and patient eligibility

About

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

Full description

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.

Enrollment: 121 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Incarcerated
• Prior LEEP (loop electrosurgical excision procedure), cryo (cryotherapy) or CKC (cold knife cone) of the cervix

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

121 participants in 2 patient groups

Fast placement

No Intervention group

Description:

Placement of the tenaculum quickly and without avoiding ratchet

Slow placement of the tenaculum

Experimental group

Description:

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

Treatment:

Procedure: Slow placement of the tenaculum