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Music intervention at home. Patients will be asked to listen to music using their own equipment three times a day. Starting approximately a week prior to surgery up to the day of surgery.

Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.

Music

Jorrit G Verhoeven, MSc, MD

Eric Belt, Dr.

Marijn Poelman, Dr.

Erwin van der Harst, Dr

Markus Klimek, MD, PhD

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

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.

Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial

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.

Length of peroperative sedation as recorded in EHR by attending anesthesist

Complications that occur during the surgery are recorded in the EHR and will be extracted

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.

Pain scores are gathered thrice daily by nurses as part of standard care

Diagnosis of delirium by geriatricians or psychiatrists as noted in the electronic health report were considered as a confirmed diagnosis of delirium

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.

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)(

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.

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

A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.

Complication documentation as provided my medical staff and associated Clavien-Dindo score

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery	NCT05982184	Cancer of Colon Surgery Anxiety	Music	16 Years -	Erasmus Medical Center
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery	NCT05982184	Cancer of Colon Surgery Anxiety	Music	16 Years -	Erasmus Medical Center

Spots Global Cancer Trial Database for non pharmacological intervention