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临床试验/NCT01576302
NCT01576302已完成3 期

Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Mayo Clinic
入组人数
13
试验地点
2
主要终点
Rumination Frequency assessed using Rome III Criteria

研究概览

简要总结

Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination.

To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age.
  • Diagnosis of rumination by RomeIII criteria

排除标准

  • Active alcohol or substance abuse
  • Presence of a depressive disorder as measured by PHQ-9 score of 10 or above
  • Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above.
  • Severe levels of health focused anxiety as measured by SHAI score of 26 or above.
  • Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures.
  • Any active psychosis or suicidality.

结局指标

主要结局

Rumination Frequency assessed using Rome III Criteria

时间窗: 1 month after intervention

Study participants will be treated with diaphragmatic breathing in one arm and muscle relaxation in the other arm. Outcome measure is: Rome III Study Questions Q8: In the last week, how often did food come back up into your mouth? Q10: When food came back up into your mouth, did it usually stay in your mouth for a while before you swallowed it or spit it out?

Rumination frequency assessed using Rome III Criteria

时间窗: 3 months after intervention

Study participants will be treated with diaphragmatic breathing in one arm and muscle relaxation in the other arm. Outcome measure is: Rome III Study Questions Q8: In the last week, how often did food come back up into your mouth? Q10: When food came back up into your mouth, did it usually stay in your mouth for a while before you swallowed it or spit it out?

次要结局

  • Heath Care Utilization(3 month after intervention)
  • Short Health Anxiety Inventory (SHAI)(3 months post intervention)
  • Treatment adherence(3 months after intervention)
  • Sheehan Disability Scale (SDS)(3 months after intervention)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard J. Seime

PHD

Mayo Clinic

研究点 (2)

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