Postop Adult ICU PatientsPhase 3NCT01409044
Effect of Music on Pain and Anxiety After Surgery
A Phase 3 study testing Music in people with Postop Adult ICU Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Studies have shown that listening to music can decrease pain and anxiety. Following surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and anxiety. But these drugs can cause side effects such as low blood pressure and confusion. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postop Adult ICU Patients
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2011to 8 Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult surgical patients hospitalized in the NIH, Clinical Center (CC) who have an anticipated ICU stay of 24-48 hours postoperatively and the planned postoperative pain management schema includes opioids delivered via intravenous or epidural PCA device.
- General surgery, urology and thoracic surgery patients
- Oriented to person, time and place
- Age greater than or equal to 18 years
- Understands and speaks English or Spanish
Who cannot join
- Scheduled for a neurosurgical procedure
- Hearing or visually Impaired
- Diagnosed with General Anxiety Disorder (GAD) or patients who score greater than or equal to 15 on the GAD-7 screening instrument.
- Speaks language other than Spanish or English
- Intubated for greater than 4 hours post-operatively
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Music Listening on the Amount of Opioids Used in Surgical Intensive Care Patients
Background:
- Studies have shown that listening to music can decrease pain and anxiety. Following surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If listening to music can help lower pain and anxiety levels, less medication might be needed and these side effects could be avoided.
Read more
Objectives:
- To determine the effects of music on patient pain and anxiety in the first few days after surgery.
Eligibility:
- Individuals at least 18 years of age who are scheduled to have surgery that requires a 24-48-hour stay in intensive care afterward.
Design:
- All participants will be screened with a medical history before having surgery.
- Participants will be divided into two groups: one group will listen to music after surgery, and the other will not.
- Before surgery, participants will answer questions about their pain and anxiety levels. They will also be shown how to control the device that lets them administer their own pain medication after surgery.
- Following surgery, all participants will be transferred to the ICU and will answer the same questions about pain and anxiety levels.
- The music group will listen to a specially created CD of instrumental music for about 50 minutes, four times a day. The standard group will not listen to this music. All other treatments will be the same in both groups. Both groups will continue to answer the same questions about pain and anxiety levels.
- Participants will have a final 15- to 20-minute interview after leaving the ICU. They will answer questions about the ICU stay and (for those in the music listening group) the music.
Read the detailed description
Background:
- Listening to music is a common human activity. Music listening has been associated with decreased pain scores, increase in attentiveness and decrease in anxiety scores. Recently, with interest in holistic and complementary and alternative therapies, there has been increased awareness of the potential positive health effects of music listening.
- Inadequate pain management remains common especially in postoperative patients. Acute perioperative pain affects over 46 million Americans every year.
- As music is processed by the limbic system, enkephalins and endorphins are released. These substances are natural occurring opioids, suggesting music may decrease patient s requirements for opioids.
Primary Objective:
To determine the effects of music listening on the amount of opioids delivered postoperatively to adult ICU patients via patient-controlled analgesia (PCA) during the first 48 hours.
Secondary Objective:
To determine the effects of music listening on pain and anxiety scores experienced by adult surgical patients during the first 48 hours postoperatively in the ICU.
Eligibility:
-All adult patients (18 years of age or greater) who are scheduled for surgery that have an anticipated ICU stay of 24-48 hours.
Design:
The design is a two-group randomized controlled trial. The two groups are:
- Treatment -Music group - intervention music delivered for approximately 50 minutes 4 times a day
- Control - Standard care
- Conditions
- Postop Adult ICU Patients
- Being tested
- Music
- Keywords
- Patient-Controlled Analgesia (PCA), Music Listening, Opioids, Post Surgical Intensive Care Patient, Patient-Controlled Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music listening for the treatment group. Music is from MusicCure selection "Dreams". Outocmes are compared to control group who receives no music. Subjects are randomized Post-operatively.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Research participant listened to music Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate use
Measured: 48 hours in the ICU
Secondary outcomes (1)
Pain, anxiety and distress outcome measures
Measured: 48 hours in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study start17 Jun 2011
- Primary completion9 May 2013
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postop Adult ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Ames, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409044
- Sponsor's protocol ID
- 110201
- Other IDs
- 11-CC-0201
- Status last verified
- 8 Aug 2017
- First submitted
- 2 Aug 2011
- Last updated
- 10 Aug 2017
- Results posted
- No
Publications
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
PubMed 12873949Garnett RL, MacIntyre A, Lindsay P, Barber GG, Cole CW, Hajjar G, McPhail NV, Ruddy TD, Stark R, Boisvert D. Perioperative ischaemia in aortic surgery: combined epidural/general anaesthesia and epidural analgesia vs general anaesthesia and i.v. analgesia. Can J Anaesth. 1996 Aug;43(8):769-77. doi: 10.1007/BF03013027.
PubMed 8840054Beattie WS, Buckley DN, Forrest JB. Epidural morphine reduces the risk of postoperative myocardial ischaemia in patients with cardiac risk factors. Can J Anaesth. 1993 Jun;40(6):532-41. doi: 10.1007/BF03009738.
PubMed 8403120
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Listening on the Amount of Opioids Used in Surgical Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01409044
- Acronym / sponsor ID
- 110201
- Conditions
- Postop Adult ICU Patients
- Keywords
- Patient-Controlled Analgesia (PCA), Music Listening, Opioids, Post Surgical Intensive Care Patient, Patient-Controlled Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 17 Jun 2011
- Primary completion
- 9 May 2013 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Studies have shown that listening to music can decrease pain and anxiety. Following surgery, patients in intensive care units (ICUs) often need drugs to treat their pain and anxiety. But these drugs can cause side effects such as low blood pressure and confusion. If listening to music can help lower pain and anxiety levels, less medication might be needed and these side effects could be avoided.
Objectives:
- To determine the effects of music on patient pain and anxiety in the first few days after surgery.
Eligibility:
- Individuals at least 18 years of age who are scheduled to have surgery that requires a 24-48-hour stay in intensive care afterward.
Design:
- All participants will be screened with a medical history before having surgery.
- Participants will be divided into two groups: one group will listen to music after surgery, and the other will not.
- Before surgery, participants will answer questions about their pain and anxiety levels. They will also be shown how to control the device that lets them administer their own pain medication after surgery.
- Following surgery, all participants will be transferred to the ICU and will answer the same questions about pain and anxiety levels.
- The music group will listen to a specially created CD of instrumental music for about 50 minutes, four times a day. The standard group will not listen to this music. All other treatments will be the same in both groups. Both groups will continue to answer the same questions about pain and anxiety levels.
- Participants will have a final 15- to 20-minute interview after leaving the ICU. They will answer questions about the ICU stay and (for those in the music listening group) the music.
Detailed description
Background:
- Listening to music is a common human activity. Music listening has been associated with decreased pain scores, increase in attentiveness and decrease in anxiety scores. Recently, with interest in holistic and complementary and alternative therapies, there has been increased awareness of the potential positive health effects of music listening.
- Inadequate pain management remains common especially in postoperative patients. Acute perioperative pain affects over 46 million Americans every year.
- As music is processed by the limbic system, enkephalins and endorphins are released. These substances are natural occurring opioids, suggesting music may decrease patient s requirements for opioids.
Primary Objective:
To determine the effects of music listening on the amount of opioids delivered postoperatively to adult ICU patients via patient-controlled analgesia (PCA) during the first 48 hours.
Secondary Objective:
To determine the effects of music listening on pain and anxiety scores experienced by adult surgical patients during the first 48 hours postoperatively in the ICU.
Eligibility:
-All adult patients (18 years of age or greater) who are scheduled for surgery that have an anticipated ICU stay of 24-48 hours.
Design:
The design is a two-group randomized controlled trial. The two groups are:
- Treatment -Music group - intervention music delivered for approximately 50 minutes 4 times a day
- Control - Standard care
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicResearch participant listened to music |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult surgical patients hospitalized in the NIH, Clinical Center (CC) who have an anticipated ICU stay of 24-48 hours postoperatively and the planned postoperative pain management schema includes opioids delivered via intravenous or epidural PCA device.
- General surgery, urology and thoracic surgery patients
- Oriented to person, time and place
- Age greater than or equal to 18 years
- Understands and speaks English or Spanish
Key exclusion criteria (5 listed)
- Scheduled for a neurosurgical procedure
- Hearing or visually Impaired
- Diagnosed with General Anxiety Disorder (GAD) or patients who score greater than or equal to 15 on the GAD-7 screening instrument.
- Speaks language other than Spanish or English
- Intubated for greater than 4 hours post-operatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic listening for the treatment group. Music is from MusicCure selection "Dreams". Outocmes are compared to control group who receives no music. Subjects are randomized Post-operatively. | Other | Music |
Primary outcome
Opiate use
Time frame: 48 hours in the ICU
1 secondary outcome
Pain, anxiety and distress outcome measures
Time frame: 48 hours in the ICU
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Background: PubMed 12873949Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
- Background: PubMed 8840054Garnett RL, MacIntyre A, Lindsay P, Barber GG, Cole CW, Hajjar G, McPhail NV, Ruddy TD, Stark R, Boisvert D. Perioperative ischaemia in aortic surgery: combined epidural/general anaesthesia and epidural analgesia vs general anaesthesia and i.v. analgesia. Can J Anaesth. 1996 Aug;43(8):769-77. doi: 10.1007/BF03013027.
- Background: PubMed 8403120Beattie WS, Buckley DN, Forrest JB. Epidural morphine reduces the risk of postoperative myocardial ischaemia in patients with cardiac risk factors. Can J Anaesth. 1993 Jun;40(6):532-41. doi: 10.1007/BF03009738.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Ames, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Music in people with Postop Adult ICU Patients, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opiate use (time frame: 48 hours in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01409044, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.