Preoperative Relaxation and Intensified Patient Surgery Education in Patients Undergoing Cholecystectomy

Gall Stones Clinical Trial

— MBM_Galle  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02481271
• Other study ID #: 14-6061-BO MBM_Galle
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2015
• Last updated: May 23, 2017
• Start date: December 2015
• Est. completion date: June 2017

Study information

• Verified date: May 2017
• Source: Universität Duisburg-Essen
• Contact: Gustav Dobos, Prof, MD
• Phone: +49201174
• Email: g.dobos[@]kliniken-essen-mitte.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gall Stones
• Gallstones

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
Germany	Abteilung für Allgemein-, Viszeral-, Gefäßchirurgie und Koloproktologie, Johanniter-Krankenhaus Rheinhausen	Duisburg

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	course of surgery	blood pressure, use of medication during operation, amount of gases during insufflation	day of surgery
Primary	preoperative anxiety	State Anxiety (STAI-S) (Spielberger 1970)	day of surgery
Primary	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	preoperative anxiety	Trait Anxiety (STAI-T) (Spielberger 1970)	day of surgery
Secondary	preoperative anxiety	Amsterdam Preoperative Anxiety and Information Scale (APAIS) (Berth 2007)	day of surgery
Secondary	preoperative anxiety	Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA) (Wetsch 2009)	day of surgery
Secondary	postoperative disability	interference of pain with movement, coughing, waking up at night and disturbed mood	day after surgery
Secondary	postoperative disability	interference of pain with movement, coughing, waking up at night and disturbed mood	2 days after surgery
Secondary	postoperative disability	interference of pain with movement, coughing, waking up at night and disturbed mood	10 days after surgery
Secondary	postoperative fatigue	Fatigue measured by 0-10 Numeric Rating Scale	Day after surgery
Secondary	postoperative fatigue	Fatigue measured by 0-10 Numeric Rating Scale	2 days after surgery
Secondary	postoperative fatigue	Fatigue measured by 0-10 Numeric Rating Scale	10 days after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	Day after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	2 days after surgery
Secondary	postoperative nausea	Nausea measured by 0-10 Numeric Rating Scale	10 days after surgery
Secondary	postoperative complications	postoperative complications such as wound healing, haematoma, seroma, swelling, nausea, vomiting, bleeding, fever	10 days after surgery
Secondary	Satisfaction with care	Satisfaction with the operation, the hospital care	10 days after surgery
Secondary	Satisfaction with interventions	Satisfaction with the interventions	10 days after surgery