MassageNCT01351402
Effects of Massage Versus Rest on Hormones
A study testing Massage or Rest in people with Massage and Rest, run by Claremont Graduate University at 1 site in United States.
Trial summary
This study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Massage or Rest
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2007
- 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
- Anyone English speaking and over the age of 18.
Who cannot join
- Minors and anyone who has used illicit drugs or alcohol in the last 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Massage vs. Rest on Oxytocin, ACTH, and B-endorphins
This study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin, and IL-1alpha). The investigators will also investigate whether, in the case of hormones changes, these influence social decision making.
Read the detailed description
Interested participants will have the experiment explained both verbally and in writing, and asked to give their informed consent in writing. After consent, the participants will be led to a private room for their first 30ml blood draw by a qualified phlebotomist. Participants will then have a second 30ml blood draw.
- Being tested
- Massage or Rest
- Keywords
- Massage, Rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage or RestProcedure or surgery
Participants either received 15 minutes of moderate pressure Swedish massage on the upper back, or rested quietly sitting in a chair for 15 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin
Participants receive a blood draw at baseline and immediately following 15 minutes of massage or rest and oxytocin will be measured from this sample.
Measured: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Secondary outcomes (3)
Adrenocorticotrophic hormone (ACTH)
Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and ACTH will be measured in these blood samples.
Measured: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Beta-endorphin
Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and B-endorphin will be measured from these samples.
Measured: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Interleukin-1alpha (IL-1a)
Participants will receive a blood draw at baseline and immediately following 15 minutes of massage or rest, and IL-1a will be measured from these samples.
Measured: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2006
- Primary completionAug 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies 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
- Basic science
- Allocation
- Randomised
- Masking
- Single blind
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont Graduate University
- Sponsor type
- University, hospital or other
- Collaborators
- Gruter Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351402
- Sponsor's protocol ID
- 00012002
- Status last verified
- Aug 2005
- First submitted
- 6 May 2011
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Massage vs. Rest on Oxytocin, ACTH, and B-endorphins
- ClinicalTrials.gov ID
- NCT01351402
- Acronym / sponsor ID
- 00012002
- Keywords
- Massage, Rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Claremont Graduate UniversityUniversity, hospital or other
- Collaborators
- Gruter Institute
- Study start
- Jun 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 May 2011 (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 study will investigate the effects of 15 minutes of massage compared to 15 minutes of quiet rest on physiological variables. Specifically, the investigators will measure the effects on levels of the social hormone oxytocin, and on other physiological variables that interact with oxytocin or that may be influenced by massage (including ACTH, Beta-endorphin, and IL-1alpha). The investigators will also investigate whether, in the case of hormones changes, these influence social decision making.
Detailed description
Interested participants will have the experiment explained both verbally and in writing, and asked to give their informed consent in writing. After consent, the participants will be led to a private room for their first 30ml blood draw by a qualified phlebotomist. Participants will then have a second 30ml blood draw.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone English speaking and over the age of 18.
Key exclusion criteria (1 listed)
- Minors and anyone who has used illicit drugs or alcohol in the last 24 hours.
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 or RestParticipants either received 15 minutes of moderate pressure Swedish massage on the upper back, or rested quietly sitting in a chair for 15 minutes. | Procedure or surgery | – |
Primary outcome
Oxytocin
Time frame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Participants receive a blood draw at baseline and immediately following 15 minutes of massage or rest and oxytocin will be measured from this sample.
3 secondary outcomes
Adrenocorticotrophic hormone (ACTH)
Time frame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Beta-endorphin
Time frame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
Interleukin-1alpha (IL-1a)
Time frame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.
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 10 May 2011.
Related trials for Massage
Not yet recruiting
Mechanisms of Instrument-Assisted Soft Tissue Manipulation (IASTM) Force Dose-Response Effects in the Calf-Foot Region
Limited Ankle Dorsiflexion Due to Calf Muscle Tightness
Not yet recruiting
Effects of IASTM, Deep Friction Massage, and Sham Instrument-Assisted Soft Tissue Mobilization on Electromyographical Activation, Pain and Function in Non-Specific Low Back Pain
Low Back Pain, Trigger Point Pain, Myofascial
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
Not yet recruiting
Effects of Environmental Comfort and Oral Motor Stimulation on Comfort and Oral Feeding Readiness in Preterm Infants
Prematurity, Feeding Behaviors
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
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 Massage or Rest in people with Massage and Rest, run by Claremont Graduate University 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 1 inclusion and 1 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 10 May 2011. 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. 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?
Oxytocin (time frame: Within 5 minutes following experimental manipulation of either 15 minutes massage or rest.). 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 10 May 2011.