Quality of LifeNCT03569982
Integrative Care and Acupuncture in MOHS Surgery
A study testing Integrative medicine care in people with Quality of Life, run by Carmel Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Integrative medicine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Nov 2018to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to MOHS surgery
Who cannot join
- Pregnancy
- Hypertension treated with alpha and beta-blockers
- Chronic atrial fibrillation
- insulin dependent diabetes type 1
- Thyroid disease (hyperthyroidism)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- Integrative medicine care
- Keywords
- Integrative medicine, Peri-operative anxiety, Pain, MOHS surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative medicine careOther
Including acupuncture, relaxation/breathing, and manual/touch modalities
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients receiving best supportive care |
| Intervention | Experimental | Patients receiving integrative care (including acupuncture) in addition to best supportive care Receives: Other: Integrative medicine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety as assessed by State-Trait Anxiety Inventory
Alleviating anxiety throughout MOHS surgery
Measured: 8 hours
Secondary outcomes (2)
Heart rate variability (HRV)
Monitoring HRV
Measured: 30 minutes
Pain as assessed by visual analogue scale
Reducing pain before, during and following local anesthesia
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start8 Nov 2018
- Primary completion1 Dec 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Ben-Arye, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569982
- Sponsor's protocol ID
- CMC-18-0024-CTIL
- Status last verified
- Mar 2022
- First submitted
- 2 May 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Effectiveness of Acupuncture and Integrative Care in Reducing Anxiety and Pain in Patients Undergoing MOHS Surgery for Dermatological Cancers
- ClinicalTrials.gov ID
- NCT03569982
- Acronym / sponsor ID
- CMC-18-0024-CTIL
- Conditions
- Quality of Life
- Keywords
- Integrative medicine, Peri-operative anxiety, Pain, MOHS surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receiving best supportive care |
| Intervention | Experimental | Other: Integrative medicine carePatients receiving integrative care (including acupuncture) in addition to best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to MOHS surgery
Key exclusion criteria (5 listed)
- Pregnancy
- Hypertension treated with alpha and beta-blockers
- Chronic atrial fibrillation
- insulin dependent diabetes type 1
- Thyroid disease (hyperthyroidism)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrative medicine careIncluding acupuncture, relaxation/breathing, and manual/touch modalities | Other | Intervention |
Primary outcome
Anxiety as assessed by State-Trait Anxiety Inventory
Time frame: 8 hours
Alleviating anxiety throughout MOHS surgery
2 secondary outcomes
Heart rate variability (HRV)
Time frame: 30 minutes
Pain as assessed by visual analogue scale
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative medicine care in people with Quality of Life, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety as assessed by State-Trait Anxiety Inventory (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.