Integrative Care and Acupuncture in MOHS Surgery

Not Applicable

Completed

• Conditions: Quality of Life
• Interventions: Other: Integrative medicine care

• Registration Number: NCT03569982
• Lead Sponsor: Carmel Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-06-24
• Study First Posted: 2018-06-26
• Study Start: 2018-11-08
• Primary Completion: 2021-12-01
• Status Verified: 2022-03
• Study Completion: 2022-03-20
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Integrative medicine care	Patients receiving integrative care (including acupuncture) in addition to best supportive care

Primary Outcome Measures

Name	Time	Method
Anxiety as assessed by State-Trait Anxiety Inventory	8 hours	Alleviating anxiety throughout MOHS surgery

Secondary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	30 minutes	Monitoring HRV
Pain as assessed by visual analogue scale	60 minutes	Reducing pain before, during and following local anesthesia

Trial Locations

Locations (1)

Lin Medical Center; 🇮🇱 Haifa, Israel