NCT01523938

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

January 30, 2012

Last Update Submit

August 9, 2016

Conditions

Hypnotherapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    on day 7 - 30 after surgery

Secondary Outcomes (13)

  • Incidence of postoperative cognitive dysfunction three months after surgery

    three months after surgery

  • Postoperative delirium

    on day 7 - 30 after surgery

  • Reduction in pre- and postoperative agitation and anxiety

    on day 7 - 30 after surgery

  • Reduction of pain

    on day 7 - 30 after surgery

  • Reduction of stress

    on day 7 - 30 after surgery

  • +8 more secondary outcomes

Other Outcomes (1)

  • Additional blood and urine tests (concerning cardiac stratum)

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Hypnotherapy

EXPERIMENTAL
Behavioral: Hypnotherapy

No Hypnotherapy

NO INTERVENTION

Interventions

HypnotherapyBEHAVIORAL

Pre- (one session) and postoperative (two sessions) Hypnotherapy

Hypnotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Pregnancy and lactation
  • Coworkers at Charité
  • Lacking willingness to save and hand out data within the study
  • Insufficient knowledge of the German language
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Claudia Spies, MD Prof.

    Department of Anaesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum (CVK) and Campus Charite Mitte (CCM), Charite - Universitätsmedizin Berlin

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., MD Director of the Department of Anaesthesiology and Intensive Care Medicine CVK/CCM

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 1, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

DE(1)