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Original research
Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial
  1. Tashima Lambert1,
  2. Tracy Truong2,
  3. Beverly Gray3
  1. 1 Obstetrics and Gynecology, Unity Health Care, Washington, District of Columbia, USA
  2. 2 Department of Biostatistics & Bioinformatics, Duke University, Durham, North Carolina, USA
  3. 3 Obstetrics and Gynecology, Duke University Hospital, Durham, North Carolina, USA
  1. Correspondence to Dr Beverly Gray, Obstetrics and Gynecology, Duke University Hospital, Durham, NC 27710, USA; beverly.gray{at}duke.edu

Abstract

Introduction 'Slow’ and ‘cough’ techniques for tenaculum placement are commonly used. This trial sought to determine if one method of placement resulted in less pain for patients.

Methods This study was a randomised controlled trial of patients presenting for intrauterine device placement. Sixty-six participants were randomised to tenaculum placement via the 'slow' method (closure of tenaculum over a 5-s period) versus the 'cough' method (closure of tenaculum at the time of patient’s cough). The primary outcome was pain at time of tenaculum placement measured on a 100 mm visual analogue scale. The study was powered to detect a 16 mm difference in pain. Secondary outcomes included pain with insertion and provider satisfaction with tenaculum grasp. Pain scores were analysed with Wilcoxon rank-sum test.

Results Sixty-six women were enrolled, 33 randomised to each group. Demographics were similar in each group. The primary outcome of pain with tenaculum placement showed a median pain score of 44 (IQR=21, 63) with slow placement and 32 (IQR=19, 54) with cough placement. There was no significant difference in pain scores between methods of tenaculum placement (p=0.16). There was no significant difference in overall pain scores (p=0.12). Provider satisfaction was not associated with one method of placement (p=1). Pre-procedure anxiety was significantly associated with pain at the time of tenaculum placement (p=0.01).

Conclusions Neither the slow method nor cough method is superior for pain reduction or provider satisfaction. Pain with tenaculum use is significantly associated with anxiety.

Clinical trial registration NCT02969421.

  • education and training
  • long-acting reversible contraception
  • office procedure
  • IUD insertion

https://doi.org/10.1136/bmjsrh-2019-200376

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    Footnotes

    • Twitter @DrBevGray

    • Presented at This work was shared in a poster presentation at the Society of Family Planning: North America Forum on Family Planning, Atlanta, GA, USA, October 2017.

    • Contributors TL and BG offered substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. TT was responsible for data analysis and interpretation. All the authors were involved in drafting the work and revising it critically for important intellectual content. All the authors gave final approval of the version published. All the authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

    • Funding This work was supported by the Charles B. Hammond Research Fund.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.