The relief of acute pain in adult postoperative patients continues to be a common problem despite the use of pharmacologic therapies. Unrelieved pain can cause various effects including: increased heart rate and blood pressure; increased need for oxygen; tachypnea; increased susceptibility to infection; and anxiety/fear (Swift, 2018). Nurses strive to provide the best care for their patients and this includes finding alternative ways to help with unrelieved pain.
Providing music as an adjunct to the standard of care for pain has been shown to reduce acute pain in postoperative patients (Comeaux & Steele-Moses, 2013; Nilsson, Rawal, & Unosson, 2003; Zografakis-Sfakiankakis et al., 2017). The following research proposal intended for the institutional review board (IRB) will discuss the purpose of the study; background and significance; participants and methodology; recruitment; participant confidentiality; participant safety; consent process; risks and burdens; benefits; cost and payment; data and document security; and follow-up and dissemination of results.
Purpose of Study
The purpose of this study is to determine whether allowing patients to listen to their preferred choice of music compared to providing them with pre-selected instrumental music is more effective, when used as an adjunct to the standard of care for pain, on reducing the perception of pain in the adult postoperative patient.
Background and Significance
The review of literature was conducted by utilizing the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Google, Nursing Times, and Research Gate. Search terms included: music therapy, music, acute pain and postoperative pain. The review of literature proved that music, when used as an adjunct to pharmacologic therapy, is effective in reducing postoperative pain. Pain is an expected outcome of a surgical procedure, however unrelieved postoperative pain can lead to complications, delayed healing and, if not dealt with effectively, can become chronic (Swift, 2018, p. 25).
According to Nilsson, Rawal, and Unosson, (2003) the best practice for postoperative pain control management should include both pharmacological and non-pharmacological methods (p. 700). Comeaux and Steele-Moses (2013) reported “According to the Joanna Briggs Institute (2009), music therapy as a non-pharmacological adjuvant to opioid analgesia is best practice in the management of pain and anxiety” (p. 313).
In their own study, Comeaux and Steele-Moses (2013) found that the use of music therapy improved patient satisfaction of pain management in the postoperative period (p. 314). Another study also found that using music as an intervention tool in the acute postoperative period could be useful in promoting patient’s comfort and improving perception of pain (Zografakis-Sfakiankakis et al., 2017). Nilsson et al. (2003) reported that “Music is a non-pharmacological technique, that is inexpensive, non-invasive and has no side-effects that have been shown to reduce postoperative pain” (p. 700).
Music therapy has been beneficial in treating patients with a wide range of diagnoses and is effective in reducing patients’ perception of anxiety and pain as well as the need for analgesia (American Music Therapy Association, 2010). While it has been proven that music can reduce postoperative pain, the preceding studies used pre-selected instrumental or classical music, there is limited research available in the clinical setting on the effects music has on pain with regards to providing patients with preferred music choices compared to providing them with pre-selected music.
inlay and Anil (2015) conducted a cold pressor test study to induce experimental pain to determine the impact of music type on pain and stated that “Simply listening to music may not be sufficiently effective for managing pain if the music is not enjoyable for the listener…the more likable the music is to the individual, the better the effects of music listening on the pain” (p. 56). Therefore, it is important for nurses to know which type of music to implement, preferred or pre-selected, as an adjunct to reduce unrelieved postoperative pain.
Participants and Methodology
This study will be conducted as an experimental prospective randomized clinical trial in a Level II Trauma Center that has a complete team of general, specialty and trauma surgeons who perform a broad range of multiple surgeries daily. The anticipated number of participants is between 150 and 200 in a 2 month period. The inclusion criteria includes all patients age 18 or over who will be having an elective surgical procedure done, have an anticipated stay of 3 days or more, are alert and oriented and able to read and write English (for questionnaire purposes).
Exclusion criteria includes any patient with hearing loss or hearing deficit making it difficult to hear the music. Data will be collected by placing participants into two study groups, the study group (preferred music choice) and the control group (pre-selected music). Using Zografakis-Sfakiankakis’ (2017) random selection algorithm participants, if they meet the inclusion criteria, will be selected by the following: on a typical surgical day, half of the patients, the 1st and 3rd patient or every other, will be included in the study group and then the 2nd and the 4th and so on will be included in the control group.
A questionnaire will be given to all participants, since both groups with be listening to some type of music, and will include questions about demographic data including: gender, age, race, type of surgical procedure. The remaining questions will ask the participant to rate their pain using the numeric rating scale (0-10) before the start of and after listening to at least 30 minutes of music; what type of analgesic what administered for their pain;
If any other non-pharmacologic intervention took place (i.e. repositioning or application of ice); what was the patient doing before, during and after listening to music (i.e. lying in bed, up in chair, walking in room/hall, talking with visitor, reading etc.); and the date and total time listened to music between each pain medication administration (with at least 30 minutes per session).
The study group will be given an easy to use MP3 player with FM radio capability and will also be able to request their preferred songs and music to be downloaded to the device by the nurse researchers. The control group will also be given an easy to use MP3 player, without FM radio capability, that is loaded with pre-selected, by nurse researchers, instrumental/classical music. All groups will be provided with earphones to use in order to prevent disruption to other patients.
Upon check-in at the hospital for their elective surgery prospective participants, who meet the inclusion criteria, will be asked if they would like to be involved in a voluntary research study during their hospitalization. The researchers will introduce themselves, including their credentials, and will verbally inform the individual that the study is trying to determine the effects that music has, in addition to receiving the standard of care for pain, on reducing postoperative pain.
They will be informed that MP3 players as wells as earphones will be provided to them and that they will be required to fill out questionnaires during the study. Participants will be informed on how their information will be kept confidential, the risks and benefits of this study and after which will be encouraged to ask questions.
To ensure participant confidentiality and anonymity participants will be assigned a number that will be included on their questionnaires. The number that they are assigned will be determined by the order in which they leave the post anesthesia care unit (PACU). When leaving the PACU the nurse will give the known participants a manila folder that will contain the numbered questionnaires, MP3 player and instructions on use.
The first paper that the participant will see when opening the folder will include a statement to them ensuring that the information that is collected from this study from them will not be divulged to others without permission. The instructions will inform the participants to place all questionnaires and MP3 player back in the envelope upon discharge, seal it and then leave it in the designated locked box at the nurses’ station.
Listening to music is beneficial, not harmful and non-invasive. Participants will still receive the standard of care for pain. Therefore, in this study there is no risk for harm or harmful deception as both groups will be provided with a music intervention, either preferred choice or pre-selected, along with the standard of care for pain. There is no anticipated adverse events seen in implementing the intervention of music listening.
As part of the recruitment process, which includes providing information about the study, its procedures and allowing for questions, participants who have met the inclusion criteria will be informed that their participation in this study is voluntary and that if they choose to participate that they can withdraw at any time without consequences.
The other components of the informed consent will include: basis for selection; duration of participation; risks and benefits; confidentiality of records; names of investigators and contact person; statement of voluntary participation and then signature lines which will indicate consent. Even though signatures will be obtained at the time of recruitment for informed consent, the researcher will not know the identity of the participant once the study begins as they will be assigned numbers randomly as they leave the PACU.
All participants will be alert and oriented consenting adults. The participants will also be informed that once this study is finished that it is the goal to have it published in a journal for medical professionals to use as evidence for best practice.
Risks and Burdens
As stated earlier, there is to harmful effects or risks in the intervention of listening to music. However, potential burdens of this study could possibly occur when filling out the questionnaire. The participants will have to take time and effort to fill out the questionnaire each time they use the music therapy along with taking prescribed medication. This can pose as a possible inconvenience for them as they will be in a perceived state of pain.
There are many potential benefits to the participants who take part in this study. As stated earlier music therapy has been beneficial in treating patients with a wide range of diagnoses and is effective in reducing patients’ perception of anxiety and pain as well as the need for analgesia (American Music Therapy Association, 2010).
According to the American Music Therapy Association (2010) in addition to the reduction of pain and anxiety participants may experience: improved respiration, lower blood pressure, improved cardiac output, reduced heart rate, and relaxed muscle tension (p. 4). Furthermore, the results of this study can be beneficial in providing nurses and other healthcare providers with knowledge about the best type of music to use, along with the standard of care, in reducing unrelieved pain for their patients. This information can be shared and may be beneficial as an alternative to reducing pain in various other types of patient populations as well.
Cost and Payment
There will be no cost to the participants of this study as the MP3 players and the earphones will be provided to them by the researchers. No incentives will be given in recruitment or for participation in this study.
Data and Document Security
Documents for this study will be kept by the patient in the provided manila folder. Once the participant is discharged the sealed manila folder will be turned in by placing it in the designated locked box at the nurses’ station.
The folders will be picked up on a daily basis. Only the nurse researchers will have access to the locked box as well as the questionnaires. All questionnaire collected from the hospital will then be kept in a locked filing cabinet when not being used by the researchers. The data collected including informed consent will be kept for a period of 3 years.
Follow-Up and Dissemination of Results
Participants will be given the researchers contact information and will have the option to contact the researchers after 3 months to either get the results of the study or be given an approximate date of when the results will be available. Upon completion of this study the aim is to present the research results at various presentations, submit the research results for peer review and then ultimately spread the knowledge and the evidence-based intervention through publication in a peer-reviewed journal.
In conclusion, we have discussed the purpose of the study; background and significance; participants and methodology; recruitment; participant confidentiality; participant safety; consent process; risks and burdens; benefits; cost and payment; data and document security; and follow-up and dissemination of results. Researchers involved in this study welcome the critical evaluation of the IRB in order to ensure that the study will be conducted in a strong, ethical and legal manor.
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