A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women (DODIU)

A Regional, Multicenter Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women According to Their Parity

The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action.

One of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion.

There is little data in the literature on the pain experienced by patients, and even less in relation to their parity.

Several studies have been conducted and show that nulliparous women seemed to experience more intense pain compared to multiparous women (2.7 vs 1.9 p<0.05)

Study Overview

• Status: Completed
• Conditions: Intrauterine Contraceptive Device Complication

Detailed Description

The hypotheses of this study are:

• Pain is more intense in nulliparous women than in multiparous women.
• Nulliparous women are more anxious before IUD insertion than multiparous women.
• Satisfaction rates at 6 and 12 months do not differ according to parity.

Pain will be assessed at each stage of IUD insertion using a numerical pain scale from 0 to 10 for speculum insertion, Pozzi forceps insertion, and IUD insertion, by the patient herself. Pain will be reassessed 5 minutes after insertion, also by the patient.

Patients' anxiety levels will be assessed before insertion using the Spielberger State Anxiety Scale. This is a self-administered questionnaire comprising 20 items. This is a 4-point Likert scale assessing the intensity of the subject's feelings ("no," "somewhat no," "somewhat yes," "yes").

The satisfaction rate will be assessed by telephone questionnaire at 6 and 12 months, allowing us to evaluate the continuation rate as well as potential side effects of this method of contraception, such as amenorrhea, spotting, headaches, or mastalgia.

Based on the results, the aim of this study is to propose appropriate pain management and information to reduce any anxiety and reassure patients about their satisfaction with this method of contraception.

• Study Type: Observational
• Enrollment (Actual): 162

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • University Rouen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

nulliparous and multiparous women who accept the insertion of an intrauterine device

Description

Inclusion Criteria:

• Patients aged 18 or older
• Patients desiring intrauterine device (IUD) contraception.
• Patients without contraindications to the desired IUD contraception (uterine malformation, pregnancy, undiagnosed vaginal bleeding, current STI, Wilson's disease, uterine cancer, uterine fibroids, current phlebitis, breast cancer, hormone-sensitive condition, etc.).
• Patients agreeing to participate in the study.
• Patients agreeing to be contacted at 6 months and 1 year.

Exclusion Criteria:

• Patients under 18 years of age.
• Patients 25 years of age or younger who have not been screened for Chlamydia and Gonorrhea prior to IUD insertion.
• Patients with a contraindication to IUD insertion.
• Patients with risk factors for sexually transmitted infections.
• Patients with comprehension difficulties and/or a language barrier.
• Patients who object to participating in the study.
• Intrauterine device insertion by a practitioner in training (first insertion).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Nulliparous patients at the time of insertion of an intrauterine contraceptive system; The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects.
Multiparous patients at the time of insertion of an intrauterine contraceptive system; The most appropriate care will be assessed in terms of pain management and information: pain will be evaluated at each stage of IUD insertion using a numerical pain scale from 0 to 10; the patient's anxiety level will be assessed before insertion using the Spielberger State Anxiety Scale; and the satisfaction rate will be evaluated via a telephone questionnaire at 6 and 12 months, allowing for the assessment of continuation rates as well as potential side effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device.	The primary evaluation criterion is the pain experienced at each stage of IUD insertion. This will be assessed using a numerical pain scale from 0 to 10 during the insertion of the speculum, Pozzi forceps, and intrauterine device, by the patient immediately after insertion. Pain 5 minutes after insertion is also assessed using the same method.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the criteria motivating the choice of intrauterine device contraception in multiparous patients.	The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.	1 day
Evaluate the criteria motivating the choice of intrauterine device contraception in nulliparous patients.	The criteria motivating the choice of IUD contraception will be assessed using a closed-ended question containing 10 items, with multiple possible answers.	1 day
Assessing the stress generated by the insertion of an intrauterine device	The patient's anxiety level will be assessed before the procedure using the Spielberger State Anxiety Scale. This self-administered questionnaire comprises 20 items. It uses a 4-point Likert scale to evaluate the intensity of the subject's feelings ("no," "somewhat no," "somewhat yes," "yes"). Each response to an item is scored from 1 to 4, with 1 indicating the lowest level of anxiety and 4 the highest. The score is calculated by summing the scores obtained for each item. The score can therefore range from 20 to 80.	1 day
Evaluation of the rate of continued use at 6 months, then at 1 year during follow-up	The satisfaction rate will be assessed by a telephone questionnaire at 6 and 12 months, allowing for an evaluation of the continuation rate. This involves measuring the percentage of women who are still using the contraceptive system at 6 and 12 months.	12 months
Evaluation of the side effects caused by this method of contraception during follow-up.	les potentiels effets secondaires engendrés par ce mode de contraception comme l'aménorrhée, la survenue de spotting, de céphalées, ou encore de mastodynie seront évalués par un questionnaire téléphonique à 6 mois et 12mois	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Study Director: Isabelle IM MOTTE, Doctor, Service de Gynécologie-Obstétrique

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pain assessment; nulliparous/multiparous parity
• Other Study ID Numbers: 2021/091/OB; 2021-A010232-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No