The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves. The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant. Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.
In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction. The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface: * in the face area (corrugator, zygomaticus) * on the hand (skin conductance, temperature) * on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
300
Music during colonoscopy
Universitätsklinikum Ulm
Ulm, Germany
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on EKG (heart rate, heart rate variability)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on skin conductance in micro Siemens
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on skin temperature in degrees Celsius
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on Propofol Dosis in millilitres
Evaluation of sedation requirements for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on procedure time in minutes
Evaluation of examination time for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Patient satisfaction with endoscopical procedure by means of questionnaire
Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Time frame: Approximately 45 minutes after colonoscopy was finished
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Patient satisfaction with sedation by means of questionnaire
Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Time frame: Approximately 45 minutes after colonoscopy was finished
Endoscopist satisfaction by means of questionnaire
Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Time frame: immediately after colonoscopy was finished