HealthyNCT02261155
Changes in Sensory Perception During Hypnotic Relaxation
A study testing Hypnosis in people with Healthy, run by Ludwig-Maximilians - University of Munich.
Trial summary
Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic susceptibility will be assessed before QST. QST data before and during hypnosis will be compared. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Aug 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 to 80 years
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- health conditions of any Kind
- inability to read and/ or sign informed consent
- previous hypnosis experience
About this study
Official title: Veränderungen Der Sensibilität Durch Medizinische Hypnose
Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic susceptibility will be assessed before QST.
QST data before and during hypnosis will be compared. Observed sensory changes will be evaluated in relation to the assessed hypnotic susceptibility
Read the detailed description
Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with Harvard Group Scale. In a second session QST will be performed on the right hand.Then hypnosis will be induced with the fixation method. After that the hypnotherapist will ask them to focus their attention on imagining an individual situation of well-being and calmness the volunteers had described before hypnosis. Then QST will be performed a second time on the same location. Results be compared using student's ttest.
- Conditions
- Healthy
- Being tested
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisProcedure or surgery
Also called hypnotic relaxation
hypnotic Relaxation without specific analgesic suggestion
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Other | hypnotic induction followed by relaxation and pleasant imagery Receives: Procedure: Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quantitative Sensory Testing
Quantitative Sensory Testing, in detail the following thresholds are included in the testing: Thermal thresholds Cold detection threshold, CDT (°C from baseline 32°C) Warm detection threshold, WDT (°C from baseline 32°C) Thermal sensory limen, TSL (°C) Paradox heat sensation, PHS (x/3) Cold pain threshold, CPT (°C) Heat pain threshold, HPT (°C) Mechanical detection threshold, MDT (mN) Mechanical pain threshold, MPT (mN) Mechanical pain sensitivity, (MPS) Dynamic mechanical allodynia, (DMA) Wind-up, (WUR) Vibration detection threshold, (VDT) (x/8) Pressure pain threshold, (PPT; Pa)
Measured: 1 hour
Secondary outcomes (1)
Observed sensory changes during hypnosis compared to hypnotic susceptibility
The correlation between the obeserved changes as described above and the degree of hypnotic susceptibility
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2006
- Primary completionAug 2007
- Study completionAug 2007
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 HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Irnich, Ludwig-Maximilians - University of Munich
- Investigators
- Dominik Irnich, Pd Dr. med., Principal investigator, Multidisciplinary Pain Centre, Department of Anesthesiology, University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261155
- Sponsor's protocol ID
- LMU 137/06
- Status last verified
- Oct 2014
- First submitted
- 25 Sep 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kramer S, Zims R, Simang M, Ruger L, Irnich D. Hypnotic relaxation results in elevated thresholds of sensory detection but not of pain detection. BMC Complement Altern Med. 2014 Dec 15;14:496. doi: 10.1186/1472-6882-14-496.
PubMed 25511129
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veränderungen Der Sensibilität Durch Medizinische Hypnose
- ClinicalTrials.gov ID
- NCT02261155
- Acronym / sponsor ID
- LMU 137/06
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 10 Oct 2014 (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.
Changes in sensory thresholds and pain thresholds will be measured with quantitative sensory testing (QST) before and during hypnotic relaxation in healthy volunteers. Hypnotic susceptibility will be assessed before QST.
QST data before and during hypnosis will be compared. Observed sensory changes will be evaluated in relation to the assessed hypnotic susceptibility
Detailed description
Healthy volunteers will be recruited and tested regarding their hypnotic susceptibility with Harvard Group Scale. In a second session QST will be performed on the right hand.Then hypnosis will be induced with the fixation method. After that the hypnotherapist will ask them to focus their attention on imagining an individual situation of well-being and calmness the volunteers had described before hypnosis. Then QST will be performed a second time on the same location. Results be compared using student's ttest.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Other | Procedure: Hypnosishypnotic induction followed by relaxation and pleasant imagery |
Who may qualify
- Ages
- 18 to 80 years
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (3 listed)
- health conditions of any Kind
- inability to read and/ or sign informed consent
- previous hypnosis experience
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 |
|---|---|---|
| HypnosisAlso: hypnotic relaxationhypnotic Relaxation without specific analgesic suggestion | Procedure or surgery | Hypnosis |
Primary outcome
Changes in Quantitative Sensory Testing
Time frame: 1 hour
Quantitative Sensory Testing, in detail the following thresholds are included in the testing: Thermal thresholds Cold detection threshold, CDT (°C from baseline 32°C) Warm detection threshold, WDT (°C from baseline 32°C) Thermal sensory limen, TSL (°C) Paradox heat sensation, PHS (x/3) Cold pain threshold, CPT (°C) Heat pain threshold, HPT (°C) Mechanical detection threshold, MDT (mN) Mechanical pain threshold, MPT (mN) Mechanical pain sensitivity, (MPS) Dynamic mechanical allodynia, (DMA) Wind-up, (WUR) Vibration detection threshold, (VDT) (x/8) Pressure pain threshold, (PPT; Pa)
1 secondary outcome
Observed sensory changes during hypnosis compared to hypnotic susceptibility
Time frame: 1 hour
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 Oct 2014.
- Derived from this study: PubMed 25511129Kramer S, Zims R, Simang M, Ruger L, Irnich D. Hypnotic relaxation results in elevated thresholds of sensory detection but not of pain detection. BMC Complement Altern Med. 2014 Dec 15;14:496. doi: 10.1186/1472-6882-14-496.
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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.
Dominik Irnich, Pd Dr. med. principal investigator
Multidisciplinary Pain Centre, Department of Anesthesiology, University of Munich
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis in people with Healthy, run by Ludwig-Maximilians - University of Munich.
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 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in Quantitative Sensory Testing (time frame: 1 hour). 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 NCT02261155, 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 10 Oct 2014.