Integrative Care and Acupuncture in MOHS Surgery

NCT ID: NCT03569982

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-08

Study Completion Date

2022-03-20

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.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Patients will be referred by the surgeon to MOHS surgery without knowing if integrative care will be provided at the surgery day. Allocation of integrative care to specific surgery days will be determined by a 1:1 randomization.

Study Groups

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Control

Patients receiving best supportive care

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Patients receiving integrative care (including acupuncture) in addition to best supportive care

Group Type EXPERIMENTAL

Integrative medicine care

Intervention Type OTHER

Including acupuncture, relaxation/breathing, and manual/touch modalities

Interventions

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Integrative medicine care

Including acupuncture, relaxation/breathing, and manual/touch modalities

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Carmel Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Eran Ben-Arye

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lin Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CMC-18-0024-CTIL

Identifier Type: -

Identifier Source: org_study_id

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