Music Intervention for Preoperative Anxiety and Acute Pain Among Mastectomy Patients
Condition: Breast Cancer; Mastectomy; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Anxiety is a common thing that patients experience when they are preparing to have a surgery.
      When this anxiety is not properly treated, the patients tend to consume more drugs in the
      operating room and it also cause their pain to increase after surgery. Pain after surgery is
      common among patients who have just had surgery. The pain that women who have had mastectomy
      feels after surgery is usually treated using pain killers. Yet, the pain killers are not
      enough to reduce the pain or cause some unwanted outcomes for the patients. Therefore,
      supplementing pain killers with music therapy appears to be a good way to reduce the pain and
      the unwanted outcomes that may arise from taking too much pain killers.

      This research is aimed to test how effective music that is selected by patients, considers
      their culture and psychological needs can be helpful in reducing anxiety before surgery and
      pain after surgery. Also its effect on blood pressure, breathing rate and pulse will be
      tested. The researcher also hope to know how satisfied patients who consent to participate in
      the study are with their pain management.

      The study will be done in two Nigerian hospitals and will mainly include women who have
      cancer, are above the age of 18, scheduled to have mastectomy, can read or write English or
      Pidgin, without any mental health challenge and agrees to participate in the study.

      This study hope to enrol up to 112 women and put them into two groups randomly, one group
      will receive the music intervention and the other group will receive the normal care provided
      by the hospital.

      Participants in the music intervention group will be added to a WhatsApp group on the week of
      their surgery. The WhatsApp session will be three times within the week of the surgery and
      each session will be about 30 minutes long. This study will use a combination of very short
      videos and voice notes (3 minutes) as well as real time chats and pictures to enhance
      communication on the group chat. The researcher will initiate discussions about participant's
      experience with breast cancer diagnosis, teach them about anxiety before surgery and pain
      after surgery. Then, they will ask questions that will be answered and also choose their type
      of music and send it to the group. The songs will be downloaded into a device and given to
      them on the day of surgery. They will continue to listen to the music after their surgery for
      the next two days.

      Before participants receive the music on the day of surgery, anxiety level and vital signs
      will be assessed. After the surgery, participant's pain level, vital signs and satisfaction
      with pain management before and after the intervention will be assessed. Those in the second
      group will receive a one-on-one chat with the researcher about pain after surgery.

      For all the participants, the study will be completed two days after the surgery.
    

Detailed description: 
      Music intervention (MI) is considered useful for anxiety and pain management in various
      surgical populations. It is a mind-body therapy that is expressive and requires interpersonal
      processes which could be active or passive. In MI, a combination of the emotional, physical,
      social, mental, spiritual, and aesthetic aspects of music are used to maintain and improve
      the client's health condition. MI achieves its analgesic effects by acting on mu-opiate
      receptors, morphine-6-glucuronide and the level of interleukin-6. It could also compete with
      other peripheral nerve stimuli such as pain transmission to the brain via the spinal cord. MI
      also enacts a powerful and subtle psychological effect on people because it is rooted in
      their emotional lives. The psychological effect is rooted in the entrainment to the rhythm of
      the music which causes alteration of the neuron activities in the lateral temporal lobe.

      A systematic review of literature conducted revealed that MI has been employed both in the
      preoperative phase for the management of anxiety and in the postoperative phase for the
      management of postoperative pain in breast cancer patients undergoing surgery. All the
      studies included in the systematic review used music that is culture-specific and
      face-to-face mode of delivery. None of the studies used theory-driven approach in their
      intervention development nor considered both preoperative and postoperative patient outcomes
      together.

      Sequel to the recent global pandemic, many healthcare facilities are restricting access to
      patients in clinical settings creating limitations for music therapy interventions that rely
      on only face-to-face mode of delivery. Therefore, the delivery of music therapy via hybrid
      mode becomes an area worthy of research. As with the traditional delivery mode, the cultural
      context and the use of theory-driven intervention are considerations to be made when
      developing the intervention. In order to develop a theory-driven and culture-specific
      intervention, the Symptom Management Model (SMM) will be adopted in this study. SMM was
      selected based on the review of other literature on MI and considering the relatedness of
      components of MT and the components of the SMM.

      Theoretical framework underpinning MI As stated previously, the SMM could underpin the MI in
      this study. The model was firstly developed by the School of Nursing symptom management
      faculty group of the University of California, San Francisco, and further revised. It has
      three domains which are symptom experience, symptom management strategy and symptom outcomes.
      The domains are dependent on the nursing concepts of person, environment, and health and
      illness. The symptom is described as a subjective experience that evinces a patient's
      biopsychosocial functioning, cognition, and sensation.

      Symptom perception, evaluation and response to symptoms are the concepts indicated in the
      symptom experience domain. The symptom experience domain is directly influenced by risk
      factors or disease or injury and health status. For mastectomy patients, pain is usually
      influenced by the type of mastectomy and its extensiveness. However, the type of mastectomy
      to be done is dependent on the stage of cancer, the possibility of the patient undergoing
      radiotherapy, and the intended aesthetic result. The symptom management strategy domain is
      considered as a dynamic domain that aims at slowing down or averting negative outcomes using
      either professional, self-care, or biomedical strategies. MI is a type of intervention that
      can be used by both healthcare professionals and patients as an adjunct to pharmacological
      therapy for pain management. The components of the symptom management strategy include who
      delivers the intervention, what, how, when, why, where, and how much of the intervention is
      to be delivered. These are similar to the standards for reporting music intervention which
      includes consideration for the expertise, duration, frequency, dosage, mode of delivery and
      environment for the intervention to be delivered.

      Finally, the symptom outcomes domain according to the SMM includes the effects of the
      intervention on the symptom status (pain intensity and analgesic consumption), functional
      status (vital signs), mood/emotional status (anxiety), and satisfaction with care. The SMM
      stresses that symptom experience assessment and adherence to the symptom management strategy
      will influence the outcomes achieved. Since pain is multidimensional, the amenability of each
      dimension to change by MI varies.

      In relation to the findings that the cultural context in which MI will be implemented is
      crucial to the acceptance and effectiveness of the intervention and that symptom outcome in
      the SMM model in relation to MI for pain management can include symptom status (pain
      intensity and analgesic consumption), functional status (vital signs), mood/emotional states
      (anxiety), and satisfaction with care. To the best of our knowledge, an hybrid mode of
      delivering music intervention to women undergoing mastectomy has never been used to address
      postoperative pain. Given the strong relationship between music and pain, we hypothesize that
      the hybrid-mode delivered music therapy will reduce the preoperative anxiety, postoperative
      pain intensity, vital signs as well as improve satisfaction with pain management of women
      undergoing mastectomy. Therefore, this study aims to test the feasibility and evaluate the
      effectiveness of hybrid-mode delivered MI on preoperative anxiety, and acute postoperative
      pain, vital signs, analgesic consumption, and satisfaction with pain management among African
      women undergoing mastectomy.

      Objectives of the study

      The objectives of the study are to:

      i) test the feasibility of implementing the MI intervention in clinical settings in Africa
      ii) Estimate the effects of MI on preoperative anxiety, acute postoperative pain, vital
      signs, analgesic consumption, and satisfaction with pain management among African women with
      breast cancer undergoing mastectomy
    

Intervention name(s): Music intervention
Intervention type(s): Other
Intervention description(s): Three WhatsApp sessions will be delivered before the surgery. In the first session, participants will describe their experience with the diagnosis of breast cancer and acceptance. In the second session, participants will be educated on anxiety before their surgery, how anxiety is being managed in the hospital and self-care strategies for anxiety like MI, how to report preoperative anxiety. The third session will include postoperative pain education. The pain education will include information about the type of pain to expect after surgery, medications, pain reporting and MI for pain management. Telephone session; on the day of surgery and at 24 and 48 hours after surgery, a reminder will be sent to the participants by WhatsApp group chat. Face-to-face; MI delivery will involve the delivery of the MP3 to participants and monitoring of their use for 30 minutes both on the day of surgery and 24 and 48 hours after surgery.
Other intervention name(s): Hybrid-mode delivered music intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind multicenter randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care