跳至主要内容
临床试验/NCT07488442
NCT07488442招募中不适用

An Evaluation of the Efficacy of Cognitive Behavioral Therapy Administered in Conjunction With Pelvic Floor Exercises in Patients With Dyssynergic Defecation

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2026年3月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
26
试验地点
1
主要终点
Wexner Constipation Score

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of cognitive-behavioral therapy when used in conjunction with lifestyle modifications and pelvic floor rehabilitation.

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
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A history of constipation lasting longer than one year
  • Chronic constipation as defined by the Rome IV criteria
  • Being between the ages of 18 and 55
  • Findings consistent with dyssynergic defecation on anorectal manometry and balloon defecography
  • Exclusion of organic and metabolic causes of chronic constipation

排除标准

  • Active bowel disease
  • Presence of an active anal fissure
  • History of major abdominal surgery
  • Presence of a neurological disorder
  • Presence of a serious psychiatric disorder
  • Use of medications that cause constipation

研究组 & 干预措施

Pelvic floor rehabilitation

Active Comparator

Patients in the first group will receive education on lifestyle changes, and a rehabilitation program consisting of 15 sessions of relaxation and Kegel exercises-held three days a week at the pelvic floor unit-will be planned.

干预措施: Pelvic floor rehabilitation (Other)

Pelvic floor rehabilitation+cognitive behavioral therapy

Experimental

In addition to these treatments, patients in the second group will receive a total of five sessions of cognitive-behavioral therapy from a certified psychologist specializing in the field, focusing on their current gastrointestinal issues rather than their personal histories.

干预措施: Pelvic floor rehabilitation+cognitive behavioral therapy (Behavioral)

结局指标

主要结局

Wexner Constipation Score

时间窗: first day of treatment and 5th week of treatment

Constipation Severity Scale

时间窗: first day of treatment and 5th week of treatment

次要结局

  • Bristol Stool Chart(first day of treatment and 5th week of treatment)
  • Beck Depression Scale(first day of treatment and 5th week of treatment)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ayse Naz Kalem

PM&R Specialist

Ankara Etlik City Hospital

研究点 (1)

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