Back to resultsEffect of Music Prehabilitation on Preoperative Anxiety Before Surgery (MU-PRIOR)
Primary Purpose
Cancer of Colon, Surgery, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional treatment trial for Cancer of Colon focused on measuring Music, Colon cancer, Surgery, Anxiety, Perioperative care, Prehabilitation, Non pharmacological intervention
Eligibility Criteria
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.
Sites / Locations
- Albert Schweitzer ZiekenhuisRecruiting
- Franciscus GasthuisRecruiting
- Maasstad ZiekenhuisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music
Standard Care
Arm Description
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.
Treatment as usual.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient reported pain on a 1-10 numeric scale.
Pain scores are gathered thrice daily by nurses as part of standard care
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
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.
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)(
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.
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
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.
Rate of complications
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05982184
Brief Title
Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery
Acronym
MU-PRIOR
Official Title
Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Surgery, Anxiety
Keywords
Music, Colon cancer, Surgery, Anxiety, Perioperative care, Prehabilitation, Non pharmacological intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Treatment as usual.
Intervention Type
Other
Intervention Name(s)
Music
Other Intervention Name(s)
Music medicine, music intervention
Intervention Description
Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
Primary Outcome Measure Information:
Title
Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
Description
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 Outcome Measure Information:
Title
Patient reported pain on a 1-10 numeric scale.
Description
Pain scores are gathered thrice daily by nurses as part of standard care
Time Frame
Thrice daily on each post-operative day until discharge
Title
Incidence of delirium diagnosis made by geriatricians or psychiatrists
Description
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
Title
Delirium observation scale scores (DOS).
Description
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
Title
Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.
Description
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
Title
Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
Description
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
Title
Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
Description
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
Title
A self-made questionnaire assessing patient satisfaction regarding music intervention
Description
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
Title
Rate of complications
Description
Complication documentation as provided my medical staff and associated Clavien-Dindo score
Time Frame
Postoperatively until 30 days follow-up
Title
Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
Description
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
Other Pre-specified Outcome Measures:
Title
Age
Description
In years
Time Frame
At moment of surgery
Title
Sex
Description
Male/Female
Time Frame
at baseline
Title
BMI
Description
Quetelet index
Time Frame
At admittance
Title
Surgery characteristics
Description
Duration, type of procedure.
Time Frame
Intraoperatively
Title
Prior medical history
Description
Previous diagnoses, treatment
Time Frame
At baseline
Title
Music preferences in daily life. An 8-item researcher made questionnaire.
Description
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
Title
Length of sedation in minutes
Description
Length of peroperative sedation as recorded in EHR by attending anesthesist
Time Frame
Perioperatively
Title
Rate and type of complications during surgery as recorded in the EHR
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorrit G Verhoeven, MSc, MD
Phone
+31107040163
Email
j.g.verhoeven@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Klimek, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
State/Province
Zuid-Holland
ZIP/Postal Code
3318 AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Belt, Dr.
Facility Name
Franciscus Gasthuis
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3045 PM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marijn Poelman, Dr.
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erwin van der Harst, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
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