Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 12:04 AM
Study NCT ID:
NCT07437235
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
A Regional, Multicenter Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women According to Their Parity
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DODIU
Brief Summary:
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)
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)
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A010232-38 | OTHER | ANSM | View |