Effects of Music Listening on Pain and Patient Satisfaction Within First 48 Hours After Knee Replacment Surgery
Condition: Adjunctive Music Therapy in Total Knee Replacement
Study type: Interventional

Summary: 
      The aim of the present study is to determine if the use of music as an intervention can be
      utilized, in conjunction with normal pharmacological treatment, in decreasing pain and
      increasing patient satisfaction, in male and female total knee replacement patients, from the
      age of 50 and 70, during the first 48 postoperative hours after surgery. It is the hope that
      this study can add to current research addressing the pain relief needs of orthopedic
      patients following total knee replacement surgery using music listening as an adjuvant
      therapy.
    

Detailed description: 
      Each participant will be randomized into two different groups: the intervention group that
      will receive music listening along with the standard of care, or the control group, which
      will receive the standard of care only. Each individual will ambulate twice daily after
      surgery, and the intervention group will listen to music, with an MP3 player, for 30 minutes
      before and after each ambulation. Both groups will fill out a Visual Analog Scale (VAS) for
      pain before and after ambulation, and at the end of the study participants in the
      intervention group will fill out a 9-item questionnaire to determine patient satisfaction
      from music listening. Each subject will be assigned an ID#, and asked what type of music they
      would like to listen to if assigned to the intervention group.

      Randomization will be done using a random table of numbers with enough numbers to randomize
      the ten participants and any individuals that may decide to withdraw from the study. If the
      participant will be included in the intervention group then the MP3 player will be shown to
      the participant and instruction given on proper usage. A laminated card with instructions
      will be included to reinforce instruction. The MP3 player, along with the instructions and
      VAS forms, will be kept in a colored clipboard by the participant's bedside, easily
      accessible for listening and documentation. If the participant is not in the study they will
      be told that they will still be receiving the standard of care, and it will be important to
      be in study either way so that the information between groups can be compared. Each
      participant in the study will be told whether they will be in the intervention or control
      group in the pre-op holding area day of surgery. Those in the intervention group will then be
      instructed in the proper use of the MP3 player and how to fill out the VAS for pain form.
      This instruction will be repeated again prior to the patient's first ambulation on post-op
      day one.

      The intervention group will receive music for 30 minutes before and after ambulation on
      post-op days 1 and 2. This will be contingent on when the participant had surgery the day
      prior and when they are ready and able to begin ambulating. Participants in the intervention
      group will do a VAS prior to listening to music and then afterward while those in the control
      group will do a VAS prior to and after each ambulation. Participants will be ambulating twice
      a day, in the AM and PM so the intervention will be given twice a day. Both groups will
      receive the standard of care for pain control, which will be established by the surgeon and
      implemented by nursing. Finally, the patient satisfaction questionnaire will be given to
      participants in the intervention group to be filled out prior to discharge.

      Nursing and physical therapy will be educated on the research process, intervention, and
      related forms. This will include the proper way of turning the device on and off, how to
      adjust the volume, ways of choosing different types of music from the various playlists
      available, and how to charge or change the batteries. Instruction will be given in when and
      for how long the device should be used. In addition, nursing will be educated on proper use
      of the VAS form and patient satisfaction questionnaire.

      The intervention is estimated to take two and a half hours, over the first two post operative
      days, for setting up, listening to, and break down of the MP3 player, as well as 30 minutes
      to fill out two VAS forms and the patient satisfaction form, for a total of three hours. For
      those participants in the control group, total time will be approximately 30 minutes to fill
      out the two VAS forms over the same time period. The staff researcher will be available
      during this time period to aid in proper use of the MP3 player and in filling out the VAS and
      patient satisfaction forms so as to minimize time nursing and physical therapy would
      otherwise need to be involved with the intervention and filling out of forms.
    

Intervention name(s): Music therapy
Intervention type(s): Other
Intervention description(s): This will include 30 minutes before and after ambulation on post-op days 1 and 2. This will be contingent on when the participant had surgery the day prior and when they are ready and able to begin ambulating. Participants in the intervention group will do a VAS prior to listening to music and then afterward while those in the control group will do a VAS prior to and after each ambulation. Participants will be ambulating twice a day, in the AM and PM so the intervention will be given twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: music; total knee replacement; Pain management