Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

NCT ID: NCT02481271

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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see above

Conditions

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Gall Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Usual care

Does not receive a specific study intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

preoperative relaxation program

preoperative relaxation program

Group Type EXPERIMENTAL

relaxation program

Intervention Type BEHAVIORAL

relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises

1 week program, one introductory session and daily home practice

preoperative surgery education

single education unit to understand the complete surgical procedures

Group Type EXPERIMENTAL

surgery education

Intervention Type BEHAVIORAL

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 education

preoperative relaxation program AND single education unit

Group Type EXPERIMENTAL

relaxation program

Intervention Type BEHAVIORAL

relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises

1 week program, one introductory session and daily home practice

surgery education

Intervention Type BEHAVIORAL

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

Interventions

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relaxation program

relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises

1 week program, one introductory session and daily home practice

Intervention Type BEHAVIORAL

surgery education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 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

Exclusion Criteria

* Emergency surgery
* malignoma
* severe comorbidity
* severe psychological disorders
* immunosuppression
* coagulation disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Gustav Dobos

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustav Dobos, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Duisburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Gustav Dobos, Prof, MD

Role: CONTACT

+49201174 ext. 25001

Facility Contacts

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Georg Omlor, Prof, MD

Role: primary

+49206597 ext. 1201

References

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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.

Reference Type BACKGROUND
PMID: 10829320 (View on PubMed)

Other Identifiers

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14-6061-BO MBM_Galle

Identifier Type: -

Identifier Source: org_study_id

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