Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Mastectomy
  • Pain Postoperative
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Single-blind multicenter randomised controlled trialMasking: Single (Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 90 years
Gender
Only males

Description

MT is considered useful for anxiety and pain management in various surgical population. It is a mind-body therapy that is expressive and requires interpersonal process which could be active or passive. In MT, a combination of the emotional, physical, social, mental, spiritual and aesthetic aspects o...

MT is considered useful for anxiety and pain management in various surgical population. It is a mind-body therapy that is expressive and requires interpersonal process which could be active or passive. In MT, a combination of the emotional, physical, social, mental, spiritual and aesthetic aspects of music is used to maintain and improve client's health condition. MT achieves its analgesic effects by acting on mu-opiate receptors, morphoine-6-glucoronide 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. MT 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 MT 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 health care 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 bybrid 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 review of other literature on MT and considering the relatedness of components of MT and the components of the SMM. Theoretical framework underpinning MT As stated previously, the SMM could underpin the MT 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. 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 the cancer, possibility of the patient undergoing radiotherapy and intended aesthetic result. The symptom management strategy domain is considered as a dynamic domain which aims at slowing down, or averting negative outcomes using either professional, self-care or biomedical strategies. MT 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 includes 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 include the effects of the intervention on the symptom status (pain intensity and analgesia consumption), functional status (haemodynamics), 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 MT varies. In relation to the findings that the cultural context in which MT will be implemented is crucial to the acceptance and effectiveness of the intervention and that symptom outcome in the SMM model in relation to MT for pain management can include symptom status (pain intensity and analgesia consumption), functional status (haemodynamics), mood/emotional status (anxiety), and satisfaction with care. To our best of knowledge, an hybrid mode of delivering music therapy to women undergoing music therapy has never been used to address postoperative pain. Given the strong relationship in between the music and pain, we hypothesize that the hybrid-mode delivered music therapy will reduce the preoperative anxiety, postoperative pain intensity, heamodynamics as well as improve satisfaction with pain management of women undergoing mastectomy. Therefore, this study aims to evaluate the effectiveness of hybrid mode delivered music therapy on preoperative anxiety, and acute postoperative pain, haemodynamic readings, analgesia consumption, and satisfaction with pain management among Nigerian women undergoing mastectomy. Objectives of the study The objectives of the study are to: i) evaluate the effectiveness of MT on preoperative anxiety, acute postoperative pain, postoperative haemodynamic readings, analgesia consumption among Nigerian women with breast cancer undergoing mastectomy; and ii) assess patient satisfaction with pain management among Nigerian women after mastectomy Hypotheses It is hypothesised that when compared with participants in the control group, participants who receive MT will have: a significantly lower level of preoperative anxiety before mastectomy a significantly lower level of pain intensity after mastectomy a significantly improved level of haemodynamic (Blood pressure, heart rate and respiratory rate) after mastectomy a significantly lower level of analgesia consumption after mastectomy a significantly higher level of satisfaction with pain management after mastectomy.

Tracking Information

NCT #
NCT04824183
Collaborators
Not Provided
Investigators
Study Chair: Ka Ming Chow, DN The Nethersole School of Nursing, Chinese University of Hong Kong