AnxietyNCT01667328
Preoperative Massage in Breast Surgery Patients
A study testing Massage therapy in people with Anxiety and Presurgical Anxiety, run by Vassar Brothers Medical Center at 1 site in United States.
Trial summary
This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Presurgical Anxiety, Breast Cancer
- What is being tested?
- Massage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 19 Mar 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Must speak English
- Able to give consent
- 18 years of age or older
- Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center
Who cannot join
- Anxiolytics or antidepressants medications during the previous 24 hours
- Any condition that would prohibit receiving a massage
- IV medications prior to presurgical holding VAS assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
About this study
Official title: Utility of Preoperative Massage in Breast Surgery Patients
This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.
- Conditions
- Anxiety, Presurgical Anxiety, Breast Cancer
- Being tested
- Massage therapy, Standard of care
- Keywords
- Anxiety, Presurgical anxiety, Breast Cancer
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyProcedure or surgery
Presurgical 15 minute massage performed by a licensed massage therapist
Standard of careProcedure or surgery
Control group will receive standard of care with no massage therapy
| Study group | Role | What they receive |
|---|---|---|
| Massage therapy | Experimental | This group will received presurgical massage Receives: Procedure: Massage therapy |
| Control | Placebo comparator | Standard of care with no massage Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Assessments will be done immediately post registration and immediately prior to surgery
Measured: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2018
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vassar Brothers Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Health Quest Systems, Dyson Center for Cancer Care
- Responsible party
- Sponsor
- Investigators
- Angela Keleher, M.D., Principal investigator, Vassar Brothers Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667328
- Sponsor's protocol ID
- 2012-2
- Status last verified
- Apr 2018
- First submitted
- 14 Jun 2012
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Preoperative Massage in Breast Surgery Patients
- ClinicalTrials.gov ID
- NCT01667328
- Acronym / sponsor ID
- 2012-2
- Conditions
- Anxiety, Presurgical Anxiety, Breast Cancer
- Keywords
- Anxiety, Presurgical anxiety, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Vassar Brothers Medical CenterUniversity, hospital or other
- Collaborators
- Health Quest Systems, Dyson Center for Cancer Care
- Study start
- Jun 2012
- Primary completion
- Mar 2018 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 17 Aug 2012 (estimated)
- 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.
This randomized controlled interventional study is designed to determine whether breast cancer surgical patients receiving presurgical massage therapy performed by a licensed massage therapist have decreased average anxiety levels compared to the control group of breast cancer surgical patients who do not receive massage therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage therapy | Experimental | Procedure: Massage therapyThis group will received presurgical massage |
| Control | Placebo comparator | Procedure: Standard of careStandard of care with no massage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Must speak English
- Able to give consent
- 18 years of age or older
- Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers Medical Center
Key exclusion criteria (3 listed)
- Anxiolytics or antidepressants medications during the previous 24 hours
- Any condition that would prohibit receiving a massage
- IV medications prior to presurgical holding VAS assessment
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 |
|---|---|---|
| Massage therapyPresurgical 15 minute massage performed by a licensed massage therapist | Procedure or surgery | Massage therapy |
| Standard of careControl group will receive standard of care with no massage therapy | Procedure or surgery | Control |
Primary outcome
Anxiety level
Time frame: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.
Assessments will be done immediately post registration and immediately prior to surgery
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 3 May 2018.
- Vassar Brothers Medical Center's Dyson Center for Cancer CareLink provided by the sponsor.
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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.
Angela Keleher, M.D. principal investigator
Vassar Brothers Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Anxiety and Presurgical Anxiety, run by Vassar Brothers Medical Center at 1 site in United States.
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 5 inclusion and 3 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 3 May 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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 level (time frame: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.). 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 3 May 2018.