Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02481271

Acronym

MBM_Galle

Enrollment

108

Registered

2015-06-25

Start date

2015-12-31

Completion date

2017-06-30

Last updated

2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Stones

Keywords

cholecystectomy

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.

Detailed description

see above

Interventions

BEHAVIORALrelaxation program

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

BEHAVIORALsurgery 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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
postoperative pain intensity	day after the surgery, before meditation	numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
preoperative anxiety	day of surgery	State Anxiety (STAI-S) (Spielberger 1970)

Secondary

Measure	Time frame	Description
postoperative disability	day after surgery	interference of pain with movement, coughing, waking up at night and disturbed mood
postoperative fatigue	Day after surgery	Fatigue measured by 0-10 Numeric Rating Scale
postoperative nausea	Day after surgery	Nausea measured by 0-10 Numeric Rating Scale
Satisfaction with care	10 days after surgery	Satisfaction with the operation, the hospital care
Satisfaction with interventions	10 days after surgery	Satisfaction with the interventions
postoperative complications	10 days after surgery	postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever
preoperative anxiety	day of surgery	Trait Anxiety (STAI-T) (Spielberger 1970)

Other

Measure	Time frame	Description
course of surgery	day of surgery	blood pressure, use of medication during operation, amount of gases during insufflation

Countries

Germany

Contacts

Primary ContactGustav Dobos, Prof, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026