Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy (MBM_Galle)

Universität Duisburg-Essen

Status: Unknown

Conditions: Gall Stones

Treatments: Behavioral: relaxation program; Behavioral: surgery education

Study type: Interventional

Funder types: Other

Identifiers

NCT02481271

14-6061-BO MBM_Galle

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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108 participants in 4 patient groups

Usual care

No Intervention group

Description:

Does not receive a specific study intervention

preoperative relaxation program

Experimental group

Description:

preoperative relaxation program

Treatment:

Behavioral: relaxation program

preoperative surgery education

Experimental group

Description:

single education unit to understand the complete surgical procedures

Treatment:

Behavioral: surgery education

preoperative relaxation program+preoperative surgery education

Experimental group

Description:

preoperative relaxation program AND single education unit

Treatment:

Behavioral: relaxation program

Behavioral: surgery education