Structured Verbal Analgesia Versus Neutral Communication During Copper T380A IUD Insertion in Women With Previous Cesarean Delivery and No Prior Vaginal Birth: An Open-Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- pain during IUD insertion
研究概览
简要总结
This open-label, parallel-group randomized controlled trial evaluated whether structured verbal analgesia reduces pain during Copper T380A intrauterine device insertion compared with standardized neutral communication in women with previous cesarean delivery and no prior vaginal birth. Eligible women requesting Copper T380A insertion were randomized in a 1:1 ratio to receive either a structured supportive communication protocol or standardized neutral procedural communication during insertion. The primary outcome was pain intensity measured on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, with pain at the final attempted insertion step used for failed insertions.
详细描述
Copper T380A intrauterine device insertion may be associated with procedural pain, particularly in women without prior vaginal birth. Women whose delivery history is limited to cesarean section may experience greater insertion difficulty because the cervix has not undergone the dilation and remodeling associated with vaginal delivery. Nonpharmacological strategies such as structured verbal analgesia may provide a simple, low-cost adjunct for improving the insertion experience.
This study was an open-label, parallel-group randomized controlled trial with 1:1 allocation conducted at Algezeera Hospital, Giza, Egypt. Women aged 18-45 years requesting Copper T380A IUD insertion, with previous cesarean delivery and no prior vaginal birth, were randomized to structured verbal analgesia or standardized neutral communication. All participants received oral ibuprofen 600 mg approximately one hour before insertion, and the technical insertion procedure was standardized in both groups.
In the structured verbal analgesia group, the provider used calm, supportive, scripted communication with guided breathing and continuous reassurance throughout the procedure. In the standardized neutral communication group, the provider used brief procedural statements only, without additional reassurance, analgesic suggestion, or guided breathing.
The primary outcome was pain intensity on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, or at the final attempted insertion step in failed cases. Secondary outcomes included step-specific pain scores, clinician-rated insertion difficulty, procedure time, failed insertion, vasovagal episode, uterine perforation, rescue analgesia, patient satisfaction, willingness to repeat the procedure, loss to 1-month follow-up, and IUD expulsion at one month.
Before study commencement, the final ethics-approved protocol version incorporated amendments made to the originally registered protocol. These amendments were submitted to and approved by the Algezeera Hospital Research Ethics Committee before recruitment, consent, randomization, or any study-related procedure began. During the present ClinicalTrials.gov record update, the registry entry is being aligned with the final ethics-approved protocol version and the completed final study data. These updates do not reflect post-randomization changes to the randomized comparison, participant eligibility, or primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Masking of participants and providers was not feasible because the intervention consisted of the manner and content of verbal communication during the procedure. To reduce bias, both intervention and control scripts were standardized. Pain scores were recorded immediately after the relevant procedural step using a standardized 0-10 numerical rating scale by study personnel not involved in delivering the intervention; however, because the communication style was audible, outcome assessment could not be considered fully blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-45 years.
- •Requesting Copper T380A intrauterine device insertion.
- •Delivery history limited to cesarean section(s), with no prior vaginal delivery.
- •Regular menstrual cycles.
- •Eligible for Copper T380A IUD insertion according to World Health Organization medical eligibility criteria.
- •Able to provide written informed consent.
排除标准
- •Current pelvic infection, cervicitis, or vaginitis.
- •Uterine anomalies or fibroids distorting the uterine cavity.
- •Any contraindication to Copper T380A IUD insertion.
- •Contraindication to ibuprofen.
- •Use of analgesic medication within 6-8 hours before insertion.
- •Pregnancy or suspected pregnancy.
- •Severe dysmenorrhea requiring narcotic analgesia.
研究组 & 干预措施
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.
干预措施: Verbal Analgesia (Behavioral)
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.
干预措施: 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 (Behavioral)
结局指标
主要结局
pain during IUD insertion
时间窗: immediately after IUD insertion. at the time if IUD release into the uterine cavity
Pain intensity measured by a 0-10 Numerical Rating Scale (NRS) immediately after IUD release in the uterine cavity, where 0 = "no pain" and 10 = "worst pain imaginable
Pain intensity at IUD release
时间窗: Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.
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.
pain during IUD insertion
时间窗: immediately after IUD insertion. at the time if IUD release into the uterine cavity
Pain intensity measured by a 0-10 Numerical Rating Scale (NRS) immediately after IUD release in the uterine cavity, where 0 = "no pain" and 10 = "worst pain imaginable
次要结局
- Patient satisfaction(at the end of procedure before discharge from clinic)
- Clinician-rated insertion difficulty(Immediately after completion or termination of the IUD insertion procedure.)
- Pain after speculum insertion(Immediately after speculum insertion.)
- Pain after tenaculum application(Immediately after tenaculum application.)
- Pain after uterine sounding(Immediately after uterine sounding.)
- Procedure time(During the IUD insertion procedure.)
- Clinician-rated ease of insertion(Immediately after completion of IUD insertion procedure)
- Patient satisfaction(at the end of procedure before discharge from clinic)
研究者
Ahmed Samy aly ashour
principal investigator
Cairo University