Music
OtherPatient preferred music listened to through earpieces or headphones using patients' own hardware and software.
Other names: Music medicine, music intervention
NCT Number: NCT05982184
The goal of this multicenter randomized controlled trial is to investigate the effect of music prehabilitation on preoperative anxiety in patients undergoing elective oncological colorectal resection. Patients will be asked to listen to music three times a day starting one week before day of surgery. Anxiety levels will be compared with the control group that is not explicitly instructed to listen to music by using validated questionnaires
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Notify Me16 year and older
All sexes
Interventional
Not applicable
Amphia Ziekenhuis, Breda, North Brabant, Netherlands
Perioperative music interventions have been proven to have a positive effect on surgical patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new concept, which improves the patient's condition at home waiting for a surgical intervention. No studies exist in which music is implemented as a prehabilitation method. Music interventions are relatively simple low cost, sustainable and know no side effects. The researchers hypothesize that the use of pre-admittance music interventions as a prehabilitation modality in oncological colorectal surgical patients will decrease preoperative anxiety.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
Other names: Music medicine, music intervention
Time frame: Baseline and day of admittance to hospital
The STAI-6 questionnaire is a validated and frequently used six item questionnaire to assess anxiety. Six questions regarding feelings of anxiety are scored on a four point Likert scale. Scoring is achieved by reverse scoring of the positive items, sum all six scores, and multiplying the score by 20 divided by 6. The score ranges between 20 and 80, in which a higher score correlates with a higher anxiety level.
Time frame: Thrice daily on each post-operative day until discharge
Pain scores are gathered thrice daily by nurses as part of standard care
Time frame: Post-operative until discharge
Diagnosis of delirium by geriatricians or psychiatrists as noted in the electronic health report were considered as a confirmed diagnosis of delirium
Time frame: Post-operative until discharge
The DOS is a 13-point screen for delirium, based on Diagnostic and statistical manual of mental disorders version 4 (DSM-IV) delirium criteria, designed to be completed by a nurse. Responses are dichotomous. Scores ≥ 3 were considered positive delirium screens.
Time frame: Baseline, day of admittance and discharge
The PSS-10 is a validated questionnaire which assess subjective stress. It is a 10-item, comprehensive, reliable and valid instrument which is created and validated in the American population and widely used in medical/psychological studies. The items are each scored on a five-point Likert scale (ranging from 0 = never to 4 = very often). A Dutch translation of the PSS-10 was created according to the principles of good translation (the existing English version was translated to Dutch by a native Dutch speaker, afterwards the translated Dutch version was compared to the original validated English version by a native English speaker)(
Time frame: 30 days postoperatively
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame: From admission to discharge
Every medication and dose provided to the patient is recorded in the EHR and will be extracted to assess possible differences in medication requirements between intervention and control group
Time frame: 4 weeks postoperatively at follow-up
A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.
Time frame: Postoperatively until 30 days follow-up
Complication documentation as provided my medical staff and associated Clavien-Dindo score
Time frame: 4 weeks postoperatively at follow-up
The quality of recovery will be assessed using de QoR-40 questionnaire, assessed at 30 days postoperatively. This is a questionnaire which assesses five subscales, including emotional state, physical independence, psychological support, pain and physical comfort. The questionnaire uses a five-point Likert scale.
Time frame: At moment of surgery
In years
Time frame: at baseline
Male/Female
Time frame: At admittance
Quetelet index
Time frame: Intraoperatively
Duration, type of procedure.
Time frame: At baseline
Previous diagnoses, treatment
Time frame: At baseline
Items explore music listening activities, preferences for musical genres and potential music playing background. Question types varies from dichotomous answers to radio buttons, and dropdown lists.
Time frame: Perioperatively
Length of peroperative sedation as recorded in EHR by attending anesthesist
Time frame: From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)
Complications that occur during the surgery are recorded in the EHR and will be extracted
Erasmus Medical Center
Other
Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
Acronym: MU-PRIOR
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