Speed of Tenaculum Application for Procedural Pain

Overseen By Rebecca Allen, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Must not be taking: Narcotics, Opiates, Anti-anxiety, NSAIDs

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two techniques for using a tenaculum, a tool that holds the cervix during procedures, to determine which causes less pain. Participants will undergo either a fast or slow application of the tenaculum, and researchers will record their pain levels. The goal is to determine if the slow method is less painful than the fast one. Ideal candidates are women planning an IUD insertion or endometrial biopsy who have not taken pain relief or anxiety medications in the past 24 hours. As an unphased trial, this study allows participants to contribute to improving women's healthcare by identifying less painful procedural techniques.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before participating. You cannot take any pain relievers, anti-anxiety medications, narcotics, or recreational drugs in the 24 hours before the trial.

What prior data suggests that these tenaculum placement techniques are safe?

Research has shown that both fast and slow methods of using a tenaculum, a tool used during procedures like IUD insertion, have been studied for safety. The fast method is generally well-tolerated, especially with proper pain management. Studies emphasize the importance of managing pain during these procedures.

The slow method has been specifically studied for pain levels, revealing an average pain score of 44 out of 100. Some research suggests it might cause more pain than other methods, but effective pain control makes it manageable.

Overall, both methods are safe for use on the cervix. However, managing pain is crucial to ensure comfort during these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of tenaculum application speed on procedural pain, a factor that hasn't been thoroughly investigated before. While traditional approaches focus on pain management through medications or local anesthetics, this study looks at how simply altering the speed of applying a tenaculum might reduce discomfort for patients. If proven effective, this method could offer a quick, non-pharmacological way to enhance patient comfort during procedures. This could lead to improved patient experiences and potentially reduce the need for additional pain relief measures.

What evidence suggests that these tenaculum placement techniques could be effective for reducing procedural pain?

This trial will compare the effects of fast versus slow tenaculum application on procedural pain. Research has shown that the method of applying a tenaculum, a tool used to hold the cervix, can influence pain levels. Some studies found that slow application may reduce pain compared to quick application, with a median pain score of 44 on a scale from 0 to 100, compared to other techniques like coughing. However, other research suggests no significant difference in pain between slow application and other methods. Overall, evidence indicates that slower application might be less painful, but results can vary. ^{2 6 7 8 9}

Who Is on the Research Team?

Rebecca Allen, MD

Principal Investigator

Women & Infants Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18-49 planning to get an IUD or endometrial biopsy, who can consent and haven't used painkillers, anxiety meds, narcotics, or illegal drugs recently.

Inclusion Criteria

Plans for IUD insertion or endometrial biopsy

The ability and willingness to give informed consent

You have not taken pain relievers or anxiety medications in the last 24 hours.

Exclusion Criteria

You have taken any strong pain medication in the last 24 hours.

Taken any recreational or illegal drugs in the last 24 hours, such as marijuana, heroin, cocaine, crack, or methamphetamines

You have taken any anxiety medication or drug within the past 24 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tenaculum application using either fast or slow technique to measure pain perception

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Speed of tenaculum application

Trial Overview

The study compares two ways of using a tenaculum during gynecological procedures: fast vs. slow application. It aims to see which method causes less pain as measured by a pain scale.

How Is the Trial Designed?

Group I: Slow tenaculum application Experimental Treatment 1 Intervention

Group II: Fast tenaculum application Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Published Research Related to This Trial

In a study of 118 patients, endometrial sampling without a tenaculum resulted in significantly lower pain perception compared to using a tenaculum, as measured by the Visual Analog Scale (VAS).

The use of a tenaculum was identified as an independent risk factor for increased pain during the procedure, suggesting that avoiding its use may enhance patient comfort during endometrial sampling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necessity of using tenaculum for endometrial sampling procedure with pipelle: a randomized controlled study. Kucukgoz Gulec, U., Khatib, G., Guzel, AB., et al.[2019]

In a study with 50 healthy participants, it was determined that the optimal stimulation frequency for eliciting the nociceptive flexion reflex (TS-NFR) is 2.0 Hz, using three stimuli per series, which helps standardize the measurement of spinal nociception.

The study found discrepancies between TS-NFR and subjective pain ratings (TS-pain), suggesting that relying on self-reported pain may not accurately reflect spinal nociceptive processes, highlighting the need for more objective measures in pain research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing procedures to study sensitization of human spinal nociceptive processes: comparing parameters for temporal summation of the nociceptive flexion reflex (TS-NFR). Terry, EL., France, CR., Bartley, EJ., et al.[2011]

In a randomized controlled trial involving 66 women undergoing intrauterine device placement, neither the 'slow' nor 'cough' method of tenaculum placement significantly reduced pain, with median pain scores of 44 and 32 respectively (p=0.16).

Pre-procedure anxiety was found to significantly influence pain levels during tenaculum placement (p=0.01), suggesting that addressing anxiety may be important for improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. Lambert, T., Truong, T., Gray, B.[2020]

In a study of 74 women undergoing gynecologic procedures, those who received a 1% lidocaine intracervical injection reported significantly lower pain levels during tenaculum placement compared to those who received a 2% topical lidocaine gel (12.3 mm vs. 36.6 mm on a 100 mm scale).

Despite the lower pain during tenaculum placement with the injection, both groups reported similar satisfaction levels with the procedure, indicating that while the injection is more effective for pain management, it does not negatively impact overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of interventions for pain control with tenaculum placement: a randomized clinical trial. Goldthwaite, LM., Baldwin, MK., Page, J., et al.[2014]

In a study involving 58 women undergoing hysterosalpingography, both lignocaine spray and lignocaine jelly were found to be equally effective in reducing pain during the application of a tenaculum to the cervix.

Pain scores measured by visual analogue scale and verbal descriptor scale showed no significant difference between the two forms of lignocaine, indicating that either can be used effectively for pain management in this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomised, single-blinded, controlled trial comparing two topical anaesthetic modalities for the application of a tenaculum to the cervix. Costello, MF., Steigrad, S., Collet, A.[2013]

In a study with 36 healthy volunteers, varying the speed of lidocaine injections (0.3 ml/s, 0.15 ml/s, and 0.1 ml/s) did not significantly affect the pain experienced during the injections, as measured by a visual analogue scale.

Participants showed no strong preference for any specific injection speed, indicating that the speed of local anaesthetic administration within this range does not impact pain levels during subcutaneous injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of injection speed on pain during injection of local anaesthetic. Tangen, LF., Lundbom, JS., Skarsvåg, TI., et al.[2016]

The use of a suction cervical stabilizer during IUD insertion significantly reduced patient-reported pain compared to the standard single-tooth tenaculum, with pain scores lower by at least 14 points during key steps of the procedure.

The suction cervical stabilizer also demonstrated a better safety profile, with less mean blood loss compared to the control group, making it a promising alternative for IUD insertion, especially for nulliparous women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a suction cervical stabilizer for intrauterine contraceptive device insertion: Results from a randomized, controlled study. Yaron, M., Legardeur, H., Barcellini, B., et al.[2023]

In a study involving 38 adult volunteers, the speed of lidocaine injection (slow vs. rapid) did not significantly affect the success or duration of pulp anesthesia after incisive/mental nerve blocks.

However, the slow injection method was found to be significantly more comfortable for patients compared to the rapid injection method, indicating a preference for patient comfort during dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of injection speed on the effectiveness of incisive/mental nerve block: a randomized, controlled, double-blind study in adult volunteers. Whitworth, JM., Kanaa, MD., Corbett, IP., et al.[2022]

In a study with 10 healthy male volunteers, the use of EMLA cream significantly increased the time participants could tolerate tourniquet pain, allowing for an average of 46.4 minutes compared to 37.5 minutes with a placebo.

Pain scores were lower in the EMLA group at the 40-minute mark, indicating that EMLA effectively reduces pain perception associated with tourniquet use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a eutectic mixture of local anaesthetic agents (EMLA) on tourniquet pain in volunteers. Lowrie, A., Jones, MJ., Eastley, RJ.[2019]

Citations

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NCT01421641 | Tenaculum Pain Control Study

There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a ...