BYpass surgery with Psychological And Spiritual Support

ISRCTN	ISRCTN07297983
DOI	https://doi.org/10.1186/ISRCTN07297983
Secondary identifying numbers	AL 562/4-1, STR 306/21-1

Submission date: 04/12/2008
Registration date: 23/12/2008
Last edited: 23/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
We examined how much psychological and spiritual treatments improve recovery after coronary bypass surgery. One of our goals was to investigate if psychological or spiritual treatments are more effective for patients who actively chose one of these treatments compared to patients who wished to have treatment but didnt mind whether it was psychological or spiritual. Furthermore, we wanted to see whether patients who are at psychosocial risk (those who are anxious or depressed) before an operation might benefit from supportive treatments.

Who can participate?
The BYPASS study aimed to recruit about 1,000 female and male patients undergoing non-emergency coronary bypass surgery partially combined with valve surgery, over 18 years of age, from the Jena University Hospital and the Heart Centre Brandenburg, Bernau, Germany.

What does the study involve?
Upon hospital admission, patients were asked about their preference regarding supportive treatments: whether they preferred psychological treatments, spiritual treatments, treatments regardless of the profession of the therapist or if they did not want any supportive treatment. In one time period, patients got treatments according to their preference; in another time period, patients were asked about their preference but did not get any supportive treatment. At the end of the study, we compared patients who received psychological or spiritual support with patients, who stated a preference for, but did not get supportive treatments.

What are the possible benefits and risks of participating?
Patients who received supportive treatments benefited from an improvement in their mood. There were no known risks associated with participating in this trial.

Where is the study run from?
Jena University Hospital of Jena and the Heart Centre Brandenburg, Bernau, Germany.

When is study starting and how long is it expected to run for?
This trial started in October 2007 and finished in December 2009.

Who is funding the study?
German Research Council (Deutsche Forschungsgemeinschaft [DFG]), Germany.

Who is the main contact?
Dr Jenny Rosendahl
jenny.rosendahl@med.uni-jena.de

Contact information

Prof Bernhard Strauss
Scientific

Institute of Psychosocial Medicine and Psychotherapy
University Hospital Jena
Stoystrasse 3
Jena
07743
Germany

Email	bernhard.strauss@med.uni-jena.de

Study information

Study design	Partially randomised controlled multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Differential treatment effects of psychological and spiritual support on recovery and quality of life after coronary artery bypass surgery
Study acronym	BYPASS
Study objectives	1. Spiritual or psychological interventions, either according to the patients' therapeutic preference or randomly assigned, will have an positive impact on recovery and health-related quality of life following bypass surgery 2. Spiritual or psychological interventions, that are applied to the patients according to their preference, will have a greater positive impact on recovery and health-realted quality of life than randomly assigned interventions 3. Patients that are pre-operatively at psychosocial risk (high levels of anxiety or depression, lack of social support) will benefit from spiritual or psychological interventions more than patients not being at psychosocial risk
Ethics approval(s)	Ethics Committee of the Friedrich Schiller University of Jena, approved on the 13th December 2005 (ref: 1663-11/05)
Health condition(s) or problem(s) studied	Coronary artery bypass surgery partially combined with valve surgery
Intervention	Interventions, psychological as well as spiritual, are manualised and applied to the patient according to his/her individual needs at least once pre-operatively and at least once post-operatively. The total number of intervention sessions and the duration of each session depends on each participant's need. Psychological interventions include hypnotherapeutic interventions, relaxation techniques and emotional support. Spiritual interventions include patient-oriented conversations, intercessory prayer, Lords prayer, Lords supper, anointing or blessing.
Intervention type	Procedure/Surgery
Primary outcome measure	Presence of any complication following surgery within hospital stay, and following three and six months after surgery.
Secondary outcome measures	1. Patient mobility (measured with the two-minute-walking-test) at discharge 2. Patient satisfaction, assessed by the Client Satisfaction Questionnaire (CSQ-8) at discharge 3. Health-related quality of life, assessed by the 12-item Short Form (SF-12) Health Survey at three- and six-month follow-up 4. Wellbeing, assessed by a German Mood and Wellbeing scale (BFS) at discharge, three- and six-month follow-up 5. Anxiety and depression, assessed by the Hospital Anxiety and Depression Scale (HADS) at discharge, three- and six-month follow-up 6. Self-reported pain, assessed by a Visual Analogue Scale (VAS) at discharge, three- and six-month follow-up
Overall study start date	01/10/2007
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	1,000
Key inclusion criteria	1. Male and female patients aged 18 years or older 2. Scheduled for non-emergency coronary bypass surgery partially combined with valve surgery
Key exclusion criteria	Emergency cases
Date of first enrolment	01/10/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Institute of Psychosocial Medicine and Psychotherapy

Jena
07743
Germany

Sponsor information

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Research council

Kennedyallee 40
Bonn
53175
Germany

Website	http://www.dfg.de
"ROR"	https://ror.org/018mejw64

Funders

Funder type

Research council

German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) (ref: AL 562/4-1, STR 306/21-1)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/07/2009		Yes	No
Results article	results	01/07/2013		Yes	No