Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery

Anxiety Clinical Trial

— MU-PRIOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982184
• Other study ID #: 9411
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Erasmus Medical Center
• Contact: Jorrit G Verhoeven, MSc, MD
• Phone: +31107040163
• Email: j.g.verhoeven[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer of Colon
• Colonic Neoplasms
• Surgery

Intervention

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

Locations

Country	Name	City	State
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	Franciscus Gasthuis	Rotterdam	Zuid-Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	In years	At moment of surgery
Other	Sex	Male/Female	at baseline
Other	BMI	Quetelet index	At admittance
Other	Surgery characteristics	Duration, type of procedure.	Intraoperatively
Other	Prior medical history	Previous diagnoses, treatment	At baseline
Other	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.	At baseline
Other	Length of sedation in minutes	Length of peroperative sedation as recorded in EHR by attending anesthesist	Perioperatively
Other	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	From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)
Primary	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.	Baseline and day of admittance to hospital
Secondary	Patient reported pain on a 1-10 numeric scale.	Pain scores are gathered thrice daily by nurses as part of standard care	Thrice daily on each post-operative day until discharge
Secondary	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	Post-operative until discharge
Secondary	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.	Post-operative until discharge
Secondary	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)(	Baseline, day of admittance and discharge
Secondary	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.	30 days postoperatively
Secondary	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	From admission to discharge
Secondary	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.	4 weeks postoperatively at follow-up
Secondary	Rate of complications	Complication documentation as provided my medical staff and associated Clavien-Dindo score	Postoperatively until 30 days follow-up
Secondary	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.	4 weeks postoperatively at follow-up