帝王切開既往歴を有する女性における銅T380A子宮内避妊具挿入時の疼痛管理に対する言語的鎮痛法と標準的技術の比較

実験的：Verbal Analgesia

Participants randomized to the structured verbal analgesia group received a standardized supportive communication protocol throughout Copper T380A IUD insertion. The provider used a calm, low-volume voice, steady pitch, slow rate of speech, guided breathing, and continuous reassurance. The script was delivered at defined procedural steps, including before speculum insertion, during tenaculum application, during uterine sounding, during IUD insertion, and after completion of the procedure. The technical insertion procedure was otherwise identical to the control group.

行動：Verbal Analgesia

Structured verbal analgesia consisted of a scripted supportive communication protocol delivered by the provider throughout IUD insertion. The protocol used calm tone, slow speech, guided breathing, reassurance, and positive procedural framing at predefined steps. No additional pharmacologic analgesic intervention was given beyond the standard pre-procedure ibuprofen used in both groups.

アクティブコンパレータ：Control - Standard Technique

Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete." The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing. The technical insertion procedure was otherwise identical to the verbal analgesia group.

行動：Providers will use a standardized neutral script with brief instructions only (e.g., "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," "The procedure is complet

Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete." The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing. The technical insertion procedure was otherwise identical to the verbal analgesia group.

Pain intensity at IUD release

Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain was recorded immediately after release of the Copper T380A IUD into the uterine cavity. In failed insertion cases, pain at the final attempted insertion step was used as the prespecified primary-outcome substitute.

患者満足度

訪問終了時に0-10のNRS様スケールを用いて測定され、0 = 全く満足せず、10 = 最大限の満足を表します

Clinician-rated insertion difficulty

Insertion difficulty rated by the clinician using a 0-10 scale, where 0 indicates very easy insertion and 10 indicates the most difficult insertion.

Pain after speculum insertion

Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.

Pain after tenaculum application

Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.

Pain after uterine sounding

Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.

Procedure time

Procedure time measured in minutes from speculum insertion to IUD placement and string trimming, or to termination of the final insertion attempt in failed cases.