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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03569982
Other study ID # CMC-18-0024-CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2018
Est. completion date March 20, 2022

Study information

Verified date March 2022
Source Carmel Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date March 20, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Integrative medicine care
Including acupuncture, relaxation/breathing, and manual/touch modalities

Locations

Country Name City State
Israel Lin Medical Center Haifa

Sponsors (1)

Lead Sponsor Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety as assessed by State-Trait Anxiety Inventory Alleviating anxiety throughout MOHS surgery 8 hours
Secondary Heart rate variability (HRV) Monitoring HRV 30 minutes
Secondary Pain as assessed by visual analogue scale Reducing pain before, during and following local anesthesia 60 minutes
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