An interventional study of Music in Cancer of Colon, Surgery and Anxiety, sponsored by Erasmus Medical Center. Completed at 5 sites in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Treatment
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 116 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Music
Treatment as usual.
Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
Also known as: Music medicine, music intervention
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
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: Baseline and day of admittance to hospital
Patient reported pain on a 1-10 numeric scale.
Pain scores are gathered thrice daily by nurses as part of standard care
Time frame: Thrice daily on each post-operative day until discharge
Incidence of delirium diagnosis made by geriatricians or psychiatrists
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
Delirium observation scale scores (DOS).
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: Post-operative until discharge
Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at 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: Baseline, day of admittance and discharge
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
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: 30 days postoperatively
Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
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: From admission to discharge
A self-made questionnaire assessing patient satisfaction regarding music intervention
A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.
Time frame: 4 weeks postoperatively at follow-up
Rate of complications
Complication documentation as provided my medical staff and associated Clavien-Dindo score
Time frame: Postoperatively until 30 days follow-up
Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
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: 4 weeks postoperatively at follow-up
Age
In years
Time frame: At moment of surgery
Sex
Male/Female
Time frame: at baseline
BMI
Quetelet index
Time frame: At admittance
Surgery characteristics
Duration, type of procedure.
Time frame: Intraoperatively
Prior medical history
Previous diagnoses, treatment
Time frame: At baseline
Music preferences in daily life. An 8-item researcher made questionnaire.
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: At baseline
Length of sedation in minutes
Length of peroperative sedation as recorded in EHR by attending anesthesist
Time frame: Perioperatively
Rate and type of complications during surgery as recorded in the EHR
Complications that occur during the surgery are recorded in the EHR and will be extracted
Time frame: From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Erasmus Medical Center