Effect of Music on Pain and Anxiety After Surgery

NCT01409044 | Terminated Phase 3

• 2 other identifiers: 11020111-CC-0201
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postop Adult ICU Patients

Keywords

Patient-Controlled Analgesia (PCA); Music Listening; Opioids; Post Surgical Intensive Care Patient; Patient-Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Opiate use

  48 hours in the ICU

Secondary Outcomes (1)

• Pain, anxiety and distress outcome measures

  48 hours in the ICU

Study Arms (1)

Music

EXPERIMENTAL

Research participant listened to music

Other: Music

Interventions

Music OTHER

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.

Music

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12873949 BACKGROUND

• Garnett 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.

  PMID: 8840054 BACKGROUND

• Beattie 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.

  PMID: 8403120 BACKGROUND

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nancy Ames, R.N.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: June 17, 2011
• Primary Completion: May 9, 2013
• Study Completion: August 8, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08-08

Locations

US (1)