NCT02481271

Brief Summary

This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

June 22, 2015

Last Update Submit

May 23, 2017

Conditions

Gall Stones

Keywords

cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • preoperative anxiety

    State Anxiety (STAI-S) (Spielberger 1970)

    day of surgery

  • postoperative pain intensity

    numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

    day after the surgery, before meditation

Secondary Outcomes (15)

  • preoperative anxiety

    day of surgery

  • preoperative anxiety

    day of surgery

  • preoperative anxiety

    day of surgery

  • postoperative disability

    day after surgery

  • postoperative disability

    2 days after surgery

  • +10 more secondary outcomes

Other Outcomes (1)

  • course of surgery

    day of surgery

Study Arms (4)

Usual care

NO INTERVENTION

Does not receive a specific study intervention

preoperative relaxation program

EXPERIMENTAL

preoperative relaxation program

Behavioral: relaxation program

preoperative surgery education

EXPERIMENTAL

single education unit to understand the complete surgical procedures

Behavioral: surgery education

preoperative relaxation program+preoperative surgery education

EXPERIMENTAL

preoperative relaxation program AND single education unit

Behavioral: relaxation programBehavioral: surgery education

Interventions

relaxation programBEHAVIORAL

relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises 1 week program, one introductory session and daily home practice

preoperative relaxation programpreoperative relaxation program+preoperative surgery education
surgery educationBEHAVIORAL

intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery 1 single unit in the week before the surgery

preoperative relaxation program+preoperative surgery educationpreoperative surgery education

Eligibility Criteria

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

You may qualify if:

  • years old
  • referral for cholecystectomy
  • preoperative anxiety at least 4/10 points on a numeric rating scale
  • physical and mental capability to participant
  • written informed consent

You may not qualify if:

  • Emergency surgery
  • malignoma
  • severe comorbidity
  • severe psychological disorders
  • immunosuppression
  • coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen

Duisburg, 47228, Germany

RECRUITING

Related Publications (1)

  • Omlor G, Kiewitz S, Pietschmann S, Roesler S. [Effect of preoperative preoperative visualization therapy on postoperative outcome after inguinal hernia surgery and thyroid resection]. Zentralbl Chir. 2000;125(4):380-5; discussion 385-6. German.

    PMID: 10829320BACKGROUND

MeSH Terms

Conditions

Gallstones

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gustav Dobos, Prof, MD

    Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustav Dobos, Prof, MD

CONTACT

+49201174g.dobos@kliniken-essen-mitte.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 25, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

DE(1)