Integrative Care and Acupuncture in MOHS Surgery
Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Anxiety and Pain in Patients Undergoing MOHS Surgery for Dermatological Cancers
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Nov 2018
Longer than P75 for not_applicable quality-of-life
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2018
CompletedFirst Posted
Study publicly available on registry
June 26, 2018
CompletedStudy Start
First participant enrolled
November 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2022
CompletedMarch 22, 2022
March 1, 2022
3.1 years
May 2, 2018
March 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety as assessed by State-Trait Anxiety Inventory
Alleviating anxiety throughout MOHS surgery
8 hours
Secondary Outcomes (2)
Heart rate variability (HRV)
30 minutes
Pain as assessed by visual analogue scale
60 minutes
Study Arms (2)
Control
NO INTERVENTIONPatients receiving best supportive care
Intervention
EXPERIMENTALPatients receiving integrative care (including acupuncture) in addition to best supportive care
Interventions
Including acupuncture, relaxation/breathing, and manual/touch modalities
Eligibility Criteria
You may qualify if:
- \* Patients referred to MOHS surgery
You may not qualify if:
- Pregnancy
- Hypertension treated with alpha and beta-blockers
- Chronic atrial fibrillation
- insulin dependent diabetes type 1
- Thyroid disease (hyperthyroidism)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lin Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical associate professor
Study Record Dates
First Submitted
May 2, 2018
First Posted
June 26, 2018
Study Start
November 8, 2018
Primary Completion
December 1, 2021
Study Completion
March 20, 2022
Last Updated
March 22, 2022
Record last verified: 2022-03