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临床试验/NCT01200316
NCT01200316已完成1 期

Rocking Motion: Physiologic Effect on the Surgical Stress Response

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
86
试验地点
1
主要终点
Efficacy of Rocking Chair Motion on Surgical-Induced Stress

研究概览

简要总结

After having abdominal surgery, patients often experience a lack of bowel function that can cause nausea, vomiting, abdominal swelling, pain, and/or discomfort. This is known as "post-operative ileus." Patients are usually not allowed to leave the hospital until their doctor is sure that their bowel function has returned.

The goal of this clinical research study is to compare using a rocking chair to the standard of care in improving post-operative ileus after abdominal surgery.

详细描述

The standard method used to help the return of bowel function after surgery is to have patient get out of bed, sit in a chair for a period of time, and then begin walking the first day after surgery. Patients are then asked to increase the time they spend sitting in the chair and walking every day. However, it is not clear that this is the best method to assist in the return of normal bowel function. Some studies have shown that rocking in a rocking chair may help normal bowel function to return more quickly.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either group:

  • If you are in Group A, you will use the "rocking chair method." Beginning the first day after surgery, you will sit in a rocking chair and rock back and forth for 10-20 minutes at a time. This will be done for at least 60 minutes (1 hour) per day, until you pass gas for the first time after surgery. The study staff will show the correct method to rock in the rocking chair and give you time to practice while you are in the clinic.
  • If you are in Group B, you will use the standard method only. Beginning the first day after surgery, you will sit in a non-rocking chair for at least 60 minutes each day until you pass gas for the first time after surgery.

No matter what group you are in, you will also be asked to begin walking the first day after surgery until you pass gas for the first time after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least 18 years old
  • •Speak and read English
  • •Scheduled to undergo abdominal surgery
  • •Tolerate sitting in a rocking or nonrocking chair
  • •Able to ambulate
  • •Scheduled to receive epidural or intravenous patient controlled analgesia
  • •Cognitively intact
  • •Signed a study-specific informed consent prior to study entry
  • •May include patients undergoing ileostomy or colostomy reversal

排除标准

  • •All others will be excluded.

研究组 & 干预措施

Standard of Care Group

Experimental

Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.

干预措施: Standard of Care (Procedure)

Standard of Care Group

Experimental

Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.

干预措施: Questionnaire (Behavioral)

Rocking Motion Group

Experimental

Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.

干预措施: Rocking Chair Motion (Procedure)

Rocking Motion Group

Experimental

Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.

干预措施: Questionnaire (Behavioral)

结局指标

主要结局

Efficacy of Rocking Chair Motion on Surgical-Induced Stress

时间窗: 3 - 5 days

Efficacy of rocking chair motion on surgical-induced stress response as measured by salivary cortisol sample collected each morning in two groups of colon cancer patients recovering from abdominal surgery randomized to receive either a rocking chair motion intervention or standard care.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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