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Completed

NCT Number: NCT05982184

Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amphia Ziekenhuis, Breda, North Brabant, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥ 16 years
  • Patients undergoing elective oncological colorectal surgery at participating center
  • Minimal hospital stay of 2 days postoperatively.
  • Sufficient knowledge of the Dutch language
  • Communicable and able to assess the questionnaires
  • Patients who have access to personal music playing device and headphones/earphones. - Written informed consent acquired from the patient

Exclusion criteria

  • Patients with severe hearing impairment (defined as no or barely verbal communication possible).
  • Patients with an expected stay of less than two nights in the hospital
  • Patients who are professional musicians.
  • Active music players or singers who may play or sing every week
  • Patients who actively listen to music with a duration of > 30 minutes daily. Active listening is defined as music listening with headphones/earphones, while this is not combined with any other activity (e.g. exercising, working, driving or religious activities).
  • Patients who have a preoperative waiting period of less than five days.
  • Participation in another study that may possibly intervene with the outcome measures. (e.g. use of psychiatric medication during inclusion or prehabilitation interventions or similar procedures according to the judgement of the research team)
  • Assessment of primary outcome is not possible.
  • Patients with mental disorders influencing their ability to adhere to the study protocol and/or assess the questionnaires.
  • Inability or unwillingness to receive the music intervention.

Treatment and study plan

Music

Other

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

Other names: Music medicine, music intervention

Primary outcomes

  1. Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.

    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.

Secondary outcomes

  1. Patient reported pain on a 1-10 numeric scale.

    Time frame: Thrice daily on each post-operative day until discharge

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

  2. Incidence of delirium diagnosis made by geriatricians or psychiatrists

    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

  3. Delirium observation scale scores (DOS).

    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.

  4. Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.

    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)(

  5. Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.

    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.

  6. Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)

    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

  7. A self-made questionnaire assessing patient satisfaction regarding music intervention

    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.

  8. Rate of complications

    Time frame: Postoperatively until 30 days follow-up

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

  9. Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.

    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.

Other outcomes

  1. Age

    Time frame: At moment of surgery

    In years

  2. Sex

    Time frame: at baseline

    Male/Female

  3. BMI

    Time frame: At admittance

    Quetelet index

  4. Surgery characteristics

    Time frame: Intraoperatively

    Duration, type of procedure.

  5. Prior medical history

    Time frame: At baseline

    Previous diagnoses, treatment

  6. Music preferences in daily life. An 8-item researcher made questionnaire.

    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.

  7. Length of sedation in minutes

    Time frame: Perioperatively

    Length of peroperative sedation as recorded in EHR by attending anesthesist

  8. Rate and type of complications during surgery as recorded in the EHR

    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

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

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

Acronym: MU-PRIOR

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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