Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

Erasmus Medical Center116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Cancer of Colon Surgery Anxiety

Interventions

MusicOTHER

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (5)

Amphia Ziekenhuis

Breda, North Brabant, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Franciscus Gasthuis

Rotterdam, South Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)(

Data from ClinicalTrials.gov

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