HypnotherapyHYPNOCNCT01523938
Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance
A study testing Hypnotherapy in people with Hypnotherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac stratum). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnotherapy
- What is being tested?
- Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Jul 2016
- 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
- Patients aged 18 years and older
- Patients scheduled for open heart surgery or spinal column surgery
- Offered patient information and written informed consent
- Mini Mental State > 23
- American Society of Anesthesiologists physical status classification system (ASA) 1-3
Who cannot join
- No informed consent
- Patients aged <18 years
- Patients living outside Berlin/Potsdam and surrounding area
- Less than 5 points in Stanford Scale of Hypnotic Susceptibility: Form C; German version (SHSS:C -Weitzenhoffer \& Hilgard, 1962; Bongartz, 1999 a)in the screening/recruiting phase
- Lacking consent capability or accommodation in an institution due to an official or judicial order
- Emergency patients or ambulant patients
Show all 27Show fewer
- Pregnancy and lactation
- Coworkers at Charité
- Lacking willingness to save and hand out data within the study
- Insufficient knowledge of the German language
- Participation in another trial according to the German Drug Law the week before inclusion (in the study) and the parallel participation in another trial according to the German Drug Law within the first 3 months after surgery
- Acute, severe psychic disease (acute psychotic disorder, severe drug dependency, withdrawal symptoms)
- Conditions which make a sufficient information and consequent consent impossible
- The patient is under juridical supervision
- acute risk of suicide
- dementia
- patients who suffer from insulin dependent Diabetes mellitus and who have been diagnosed with Diabetes mellitus within the last year
- patients who have suffered allergic shock in the past
- hardness of hearing, deafness, blindness
- cardiac function: ejection fraction (EF) < 30%
- Patients undergoing psychotherapeutic treatment
- Patients taking awareness-modulating drugs (antipsychotic drugs)
- Boozed/primed patients or patients under drug influence
- Patients having had an epileptic seizure within the last four weeks
- Patients suffering from productive cough
- Patients having a chronic low blood pressure (systolic <90mmHg)
- Allergies to any ingredient of the electrode fixing material (only for participants of sleep stage assessment)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin
Berlin, State of Berlin, 13353
About this study
Official title: Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.
The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac stratum).
- Conditions
- Hypnotherapy
- Being tested
- Hypnotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnotherapyBehavioural
Pre- (one session) and postoperative (two sessions) Hypnotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hypnotherapy | Experimental | Not described Receives: Behavioral: Hypnotherapy |
| No Hypnotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction at the time of discharge
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Secondary outcomes (13)
Incidence of postoperative cognitive dysfunction three months after surgery
Measured: three months after surgery
Postoperative delirium
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction in pre- and postoperative agitation and anxiety
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction of pain
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction of stress
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction of holding time
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction of hospital stay
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Reduction of Intensive Care Unit stay
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Readmission rate
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Emotional status
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
Measured: on day 7 - 30 after surgery
Functional status
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery)
Measured: on day 7 - 30 after surgery
Subjective evaluation of sleep quality
Insomnia Severity Index (ISI)
Measured: Before surgery
Perioperative assessment of sleep stage
Measured: the night after surgery;the night before discharge; 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnotherapyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523938
- Sponsor's protocol ID
- HYPNOC
- Acronym
- HYPNOC
- Status last verified
- Aug 2016
- First submitted
- 30 Jan 2012
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Hypnotherapy on Postoperative Improvement in Cognitive Performance. A Randomized-controlled Open Clinical Monocentric Interventional Study.
- ClinicalTrials.gov ID
- NCT01523938
- Acronym / sponsor ID
- HYPNOC / HYPNOC
- Conditions
- Hypnotherapy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Feb 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.
The study examines prospects of hypnotherapy in reducing agitation in patients after cardiac or spinal column surgery. A particular aim is to point out the effects on postoperative cognitive outcome. Additional blood and urine tests are conducted (concerning cardiac stratum).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnotherapy | Experimental | Behavioral: Hypnotherapy |
| No Hypnotherapy | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years and older
- Patients scheduled for open heart surgery or spinal column surgery
- Offered patient information and written informed consent
- Mini Mental State > 23
- American Society of Anesthesiologists physical status classification system (ASA) 1-3
Key exclusion criteria (27 listed)
- No informed consent
- Patients aged <18 years
- Patients living outside Berlin/Potsdam and surrounding area
- Less than 5 points in Stanford Scale of Hypnotic Susceptibility: Form C; German version (SHSS:C -Weitzenhoffer \& Hilgard, 1962; Bongartz, 1999 a)in the screening/recruiting phase
- Lacking consent capability or accommodation in an institution due to an official or judicial order
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 |
|---|---|---|
| HypnotherapyPre- (one session) and postoperative (two sessions) Hypnotherapy | Behavioural | Hypnotherapy |
Primary outcome
Incidence of postoperative cognitive dysfunction at the time of discharge
Time frame: on day 7 - 30 after surgery
Planned measures on the seventh postoperative day or on day of hospital discharge (≤ 30 days after surgery).
13 secondary outcomes
Incidence of postoperative cognitive dysfunction three months after surgery
Time frame: three months after surgery
Postoperative delirium
Time frame: on day 7 - 30 after surgery
Reduction in pre- and postoperative agitation and anxiety
Time frame: on day 7 - 30 after surgery
Reduction of pain
Time frame: on day 7 - 30 after surgery
Reduction of stress
Time frame: on day 7 - 30 after surgery
Reduction of holding time
Time frame: on day 7 - 30 after surgery
Reduction of hospital stay
Time frame: on day 7 - 30 after surgery
Reduction of Intensive Care Unit stay
Time frame: on day 7 - 30 after surgery
Readmission rate
Time frame: on day 7 - 30 after surgery
Emotional status
Time frame: on day 7 - 30 after surgery
Functional status
Time frame: on day 7 - 30 after surgery
Subjective evaluation of sleep quality
Time frame: Before surgery
Perioperative assessment of sleep stage
Time frame: the night after surgery;the night before discharge; 3 months after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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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.
Claudia Spies, MD Prof. study director
Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotherapy in people with Hypnotherapy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 27 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: stopped early, as of the sponsor's last update on 10 Aug 2016. 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 Germany. 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 was stopped early. Results are not available in the source record.
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?
Incidence of postoperative cognitive dysfunction at the time of discharge (time frame: on day 7 - 30 after surgery). 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 Aug 2016.