MU-PRIOR: Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

Sponsor

Erasmus Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05982184

Collaborator

(none)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cancer of Colon Surgery Anxiety	Other: Music	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music 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 Patient preferred music listened to through earpieces or headphones using patients' own hardware and software. Other Names: Music medicine music intervention
No Intervention: Standard Care Treatment as usual.

Arm

Intervention/Treatment

Experimental: Music

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

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

Other Names:

Music medicine

music intervention

No Intervention: Standard Care

Treatment as usual.

Outcome Measures

Primary Outcome Measures

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

Patient reported pain on a 1-10 numeric scale. [Thrice daily on each post-operative day until discharge]
Pain scores are gathered thrice daily by nurses as part of standard care
Incidence of delirium diagnosis made by geriatricians or psychiatrists [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
Delirium observation scale scores (DOS). [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.
Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge. [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)(
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire. [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.
Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.) [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
A self-made questionnaire assessing patient satisfaction regarding music intervention [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.
Rate of complications [Postoperatively until 30 days follow-up]
Complication documentation as provided my medical staff and associated Clavien-Dindo score
Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery. [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 Outcome Measures

Age [At moment of surgery]
In years
Sex [at baseline]
Male/Female
BMI [At admittance]
Quetelet index
Surgery characteristics [Intraoperatively]
Duration, type of procedure.
Prior medical history [At baseline]
Previous diagnoses, treatment
Music preferences in daily life. An 8-item researcher made questionnaire. [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.
Length of sedation in minutes [Perioperatively]
Length of peroperative sedation as recorded in EHR by attending anesthesist
Rate and type of complications during surgery as recorded in the EHR [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.