Comparison of the Effectiveness of Classical Perineal Massage Therapy Versus the Use of an Intravaginal Device to Reduce Postpartum Perineal Pain
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS) - to assess pain intensity
研究概览
简要总结
GA34.01 postpartum, a randomized design with a parallel group structure will be applied, randomly assigning participants into two groups. The first group will receive the traditional perineal massage therapy, while the second group will use the intravaginal device "Crescendo 2." In this study, a pre- and post-intervention evaluation will be conducted, using the Visual Analog Scale (VAS) as the primary outcome measure and the Clinical Global Impression Scale as the secondary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older.
- •Residing in the Region of Murcia.
- •Having had a vaginal delivery between 6 weeks and 12 months prior to enrollment.
- •Presenting postpartum perineal pain, coded in ICD-11 as GA34.
- •Have not received any prior treatment for this condition.
排除标准
- •Presence of severe conditions such as:
- •Excessive postpartum hemorrhage
- •Serious infections
- •Respiratory or circulatory complications
- •Neurological disorders requiring intensive medical intervention
- •Currently under pharmacological treatment for pelvic pain.
- •Active vaginal infections.
- •Expressed refusal to participate or inability to comply with study procedures.
- •Women with episiotomy may participate only if there were no complications such as severe infection or hemorrhage following the procedure.
- •Willingness to participate and to follow the study protocol.
- •Exclusion Criteria:
研究组 & 干预措施
Use of the "Crescendo 2" Intravaginal Device
Self-administered perineal massage at home.
Three times per week, 10 minutes each session, over a 12-week period.
干预措施: Use of the "Crescendo 2" Intravaginal Device (Device)
Classical Perineal Massage Therapy
Performed manually by a pelvic floor physiotherapist.
One 30-minute session per week for 12 weeks.
干预措施: Classical Perineal Massage Therapy (Procedure)
结局指标
主要结局
Visual Analogue Scale (VAS) - to assess pain intensity
时间窗: First measure week 1 and Last measure week 12
The \*\*Visual Analogue Scale (VAS)\*\* will be used as the \*\*primary outcome measure\*\*. It consists of a horizontal line approximately 10 centimeters long. At each end of the line are the extreme expressions of pain: on the left, "no pain," and on the right, "worst imaginable pain." This tool allows us to measure the intensity of pain with high reproducibility between observers. Visual Analogue Scale (VAS): The Visual Analogue Scale is a psychometric response scale used to measure pain intensity. It typically consists of a 10-centimeter horizontal line anchored by two verbal descriptors: "no pain" (score = 0) and "worst imaginable pain" (score = 10). Minimum score: 0 (no pain) Maximum score: 10 (worst imaginable pain) Interpretation: Higher scores indicate worse outcomes (i.e., more intense pain).
次要结局
- Clinical Global Impression (CGI) - for overall health status(At the end of the treatment week 12)