N87.2 R52.9
Conditions
Interventions
Group 1: Control group: Conisation of the cervix uteri under local anaesthesia in the conventional way.
Group 2: Study group: Conisation of the cervix uteri under local anaesthesia in the conventional
Sponsors
Universitätsklinikum Augsburg
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who fulfil all of the following criteria can be included: - Patients who have been given the indication for surgical therapy by means of conisation under local anaesthesia. - Patients who have sufficient knowledge of German to be able to complete all questionnaires relevant to the study. - Patients who are of legal age - Patients who have given their written consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria cannot be included: - Patients with hearing impairment that may affect music perception. - Severe concomitant illnesses of the patient that make participation in an MGRB difficult. - Diagnosed generalised anxiety disorder or other serious psychiatric illness. - Lack of mental, physical or verbal capacity to participate in the questionnaire survey. - Legally supervised female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Does music-guided resonance breathing (MGRB) (offered perioperatively) reduce anxiety in patients undergoing cervical conisation under local anaesthesia? - Does MGRB reduce potential pain during conisation? Measurement of the different parameters at defined perioperative time points. For this purpose, the following parameters will be collected: - STAI- T and STAI-S - VAS for anxiety - Salivary cortisol measurement - Mc Gill Pain-Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| - Immediately after the operation (during postoperative monitoring) and two days after the operation (by telephone), the patients are asked in a brief survey on patient experience about their subjective assessment of A) the perceived valence ("pleasantness") of the music intervention (numerical agreement scale 1-7) and B) the subjective impression of the operation (numerical agreement scale 1-7). Furthermore, questions are asked about the influence of the music on breathing and about the emotional state during MGRB. - The MASIMO-MightySat device is a portable pulse oximeter that continuously measures changes in oxygen saturation, heart rate and respiratory rate on the left ring finger and automatically saves the measured values on an associated software (smartphone, tablet or PC). In this study, measurement with the device starts at the beginning of the preparatory phase and ends at the end of postoperative monitoring. The three measured variables serve as surrogate parameters for the objective measurement of autonomic regulation and the change in individual respiratory rate. - By comparing the R0 resection rate, any influence of MGRB on surgical outcome will be investigated. - Any influence of the intervention on the surgical setting will be investigated using the documented surgical times. | — |
Countries
Germany
Contacts
Public ContactPhilipp Morgott
Universitätsklinikum Augsburg Klinik für Frauenheilkunde und Geburtshilfe
Outcome results
None listed