Integrative Care and Acupuncture in MOHS Surgery

March 20, 2022 updated by: Eran Ben-Arye, Carmel Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Lin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

June 24, 2018

First Posted (Actual)

June 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMC-18-0024-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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