Breast Reconstruction SurgeryPhase 1/2NCT00067717
Distance Healing in Wound Healing
A Phase 1/2 study testing Distance healing in people with Breast Reconstruction Surgery, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery. Read more about this study
- Who is it for?
- Ages 34 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Reconstruction Surgery
- What is being tested?
- Distance healing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to May 2008
- Phase
- Phase 1/2
- 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 34 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing major plastic surgery (> 2 hours in length)
- Health status is excellent with no systemic disease, no limitation on activity, no danger of death or disease of one body system, well-controlled underlying disease
Who cannot join
- Remove history of breast or other cancers
- History of radiation therapy to the abdomen or any radiation within the past three months
- Non-English speaking
- Unable or unwilling to fill out questionnaires
- Current smoker
- Morbid obesity
- Circulatory inadequacies (i.e., diabetes, hypovolemia)
- Nutritional deficits as evidenced by neutropenia (WBC <2500/ml) or hypoalbuminemia (albumin <3.3mmg/dl) / chart review
Trial locations and contacts
1 site in 1 country.
United States1 site
Complementary Medicine Research Institute
San Francisco, California, 94115
About this study
Official title: Placebo Effects in Distance Healing of Wounds
This trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.
- Conditions
- Breast Reconstruction Surgery
- Being tested
- Distance healing
- Keywords
- breast reconstruction surgery, prayer, distance healing, wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distance healingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Distant Healing | Experimental | This group received distant healing but was blinded to the condition. Receives: Behavioral: Distance healing |
| Non-blinded Distant Healing | Placebo comparator | This group received the distant healing intervention and was called every day they were receiving to be told they were receiving it, therefore enhancing expectancy. Receives: Behavioral: Distance healing |
| Blinded Control | No intervention | This group was blinded to the intervention condition and did not receive any distant healing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen deposition in a surrogate wound
Measured: 8 days
Secondary outcomes (1)
POMS normalized mood scores
Compared from baseline to end of distant healing period
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2003 (estimated)
- Study startNov 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Reconstruction SurgeryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Marilyn Schlitz, California Pacific Medical Center Research Institute
- Investigators
- Marilyn J Schlitz, PhD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067717
- Sponsor's protocol ID
- R21AT001437
- Other IDs
- R21AT001437, SchlitzMJ
- Status last verified
- Oct 2014
- First submitted
- 25 Aug 2003
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schlitz M, Hopf HW, Eskenazi L, Vieten C, Radin D. Distant healing of surgical wounds: an exploratory study. Explore (NY). 2012 Jul-Aug;8(4):223-30. doi: 10.1016/j.explore.2012.04.004.
PubMed 22742672
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Effects in Distance Healing of Wounds
- ClinicalTrials.gov ID
- NCT00067717
- Acronym / sponsor ID
- R21AT001437
- Conditions
- Breast Reconstruction Surgery
- Keywords
- breast reconstruction surgery, prayer, distance healing, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 27 Aug 2003 (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 trial examines the impact of patients' knowledge of an experienced distant healer's efforts to heal them on measures of wound healing, psychosocial functioning, and physiological symptoms after plastic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Distant Healing | Experimental | Behavioral: Distance healingThis group received distant healing but was blinded to the condition. |
| Non-blinded Distant Healing | Placebo comparator | Behavioral: Distance healingThis group received the distant healing intervention and was called every day they were receiving to be told they were receiving it, therefore enhancing expectancy. |
| Blinded Control | No intervention | –This group was blinded to the intervention condition and did not receive any distant healing. |
Who may qualify
- Ages
- 34 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women undergoing major plastic surgery (> 2 hours in length)
- Health status is excellent with no systemic disease, no limitation on activity, no danger of death or disease of one body system, well-controlled underlying disease
Key exclusion criteria (8 listed)
- Remove history of breast or other cancers
- History of radiation therapy to the abdomen or any radiation within the past three months
- Non-English speaking
- Unable or unwilling to fill out questionnaires
- Current smoker
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 |
|---|---|---|
| Distance healing | Behavioural | Distant Healing, Non-blinded Distant Healing |
Primary outcome
Collagen deposition in a surrogate wound
Time frame: 8 days
1 secondary outcome
POMS normalized mood scores
Time frame: 8 days
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 20 Oct 2014.
- Background: PubMed 22742672Schlitz M, Hopf HW, Eskenazi L, Vieten C, Radin D. Distant healing of surgical wounds: an exploratory study. Explore (NY). 2012 Jul-Aug;8(4):223-30. doi: 10.1016/j.explore.2012.04.004.
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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.
Marilyn J Schlitz, PhD principal investigator
California Pacific Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Distance healing in people with Breast Reconstruction Surgery, run by California Pacific Medical Center Research Institute 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 2 inclusion and 8 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 20 Oct 2014. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Collagen deposition in a surrogate wound (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067717, which also lists 1 linked publication.
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 20 Oct 2014.