Integrative Care and Acupuncture in MOHS Surgery

Study Overview
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Brief Summary
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MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's image and anxiety about the need for repeated surgeries. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery.

Detailed Description
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MOHS method is an effective surgical technique to remove skin cancerous tumors in the head-neck area, with immediate microscopic examination in a frozen slice of the full margin. Patients undergoing MOHS surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's appearance and image and anxiety about the need for repeated surgeries performed on the same day to remove the tumor. In this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing MOHS surgery. The study was designed on the basis of interdisciplinary collaboration of researchers from plastic, integrative and gynecological medicine.

Official Title
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Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Anxiety and Pain in Patients Undergoing MOHS Surgery for Dermatological Cancers

Conditions
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Quality of Life

Intervention / Treatment
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* Other: Integrative medicine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Patients referred to MOHS surgery Exclusion Criteria: Pregnancy Hypertension treated with alpha and beta-blockers Chronic atrial fibrillation insulin dependent diabetes type 1 Thyroid disease (hyperthyroidism)

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
Interventional Model Description: Prospective randomized controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients receiving best supportive care | |
| Experimental: Intervention<br>Patients receiving integrative care (including acupuncture) in addition to best supportive care | Other: Integrative medicine care<br>* Including acupuncture, relaxation/breathing, and manual/touch modalities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety as assessed by State-Trait Anxiety Inventory | Alleviating anxiety throughout MOHS surgery | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | Monitoring HRV | 30 minutes | 
| Pain as assessed by visual analogue scale | Reducing pain before, during and following local anesthesia | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative medicine, Peri-operative anxiety, MOHS surgery, Pain