Pretreatment With Electroacupuncture to Reduce Discomfort

Study Overview
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Brief Summary
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The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

Detailed Description
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To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Official Title
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Pretreatment With Electroacupuncture to Reduce Discomfort

Conditions
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Pain

Intervention / Treatment
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* Procedure: electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer Exclusion Criteria: Ages <18y >75y Any prior gastrointestinal endoscopy. History of colonic resection. Known or suspected stenosis of the colon. Pregnancy. Inflammatory bowel disease Neuropsychiatric disorders or receiving psychotropic drugs. Prior knowledge or experience of acupuncture.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture<br>patients in whom precolonoscopic electroacupuncture is preformed | Procedure: electroacupuncture<br>* Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),<br>|
| Placebo Comparator: Sham electroacupuncture<br>sham electroacupuncture | Procedure: electroacupuncture<br>* Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),<br>|
| Sham Comparator: No intervantion<br>no intervantion | Procedure: electroacupuncture<br>* Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy | The measurement of the amount of drug added during colonoscopy | during the colonoscopy and in the hour post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of insertion till the cecum. | Time between insertion of the colonoscopy and the image of the cecum | during colonoscopy | 
| Time of post-colonoscopy recovery as measured by the Aldrete score |  | up to 1 hour post colonoscopy | 
| Number of intra-examination adverse events. |  | from the begining of the endoscopy and up to 1 hour post procedure | 
| Patient's total satisfaction with the exam and the analgesia |  | between the end of the procedure and up to 1 hour post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, acupuncture, pain