Clinical trial NCT04824183: Music Intervention for Preoperative Anxiety and Acute Pain Among Mastectomy Patients
Official title: A Pilot Study on the Effect of Culturally-adapted Music Intervention on Preoperative Anxiety and Acute Postoperative Pain Among African Women Undergoing Mastectomy: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mastectomy
Pain, Postoperative
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind multicenter randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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

Eligibility criteria: Inclusion Criteria: Women who are:

1. Aged 18 years and above
2. Diagnosed with breast cancer
3. Attending the surgical out-patient clinic for booking visit
4. Being scheduled for mastectomy
5. Can communicate verbally or in writing in English, Yoruba or Pidgin;
6. Without existing chronic pain diagnosis
7. Consent to join the study. -

Exclusion Criteria:

1. Pre-existing mental health disorders and cognitive impairment if they are 2. Transferred to the intensive care unit due to complications within the first two days after surgery.

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Primary outcomes:
measure: Change in acute postoperative pain intensity
timeFrame: Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery
Secondary outcomes:
measure: Change in preoperative anxiety
timeFrame: Pre-intervention and immediately after the intervention on the day of surgery
measure: Change in blood pressure
timeFrame: Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery
measure: Analgesia consumption
timeFrame: Post-intervention at 48 hours after surgery
measure: Satisfaction with pain management
timeFrame: Immediately after intervention at 48 hours after surgery
measure: Change in heart rate
timeFrame: Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery
measure: Change in respiratory rate
timeFrame: Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Kamuzu Central Hospital
city: Ikeja
country: Nigeria
facility: Lagos State University Teaching Hospital
state: Lagos
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Ka Ming Chow, DN
role: STUDY_CHAIR
References:
citation: Anagnostopoulos, F., 2014. Mastectomy. Encycl. Qual. Life Well-Being Res. Well-Being Res. 141, 1077-1079. https://doi.org/10.1007/978-94-007-0753-5
citation: Andersen KG, Duriaud HM, Jensen HE, Kroman N, Kehlet H. Predictive factors for the development of persistent pain after breast cancer surgery. Pain. 2015 Dec;156(12):2413-2422. doi: 10.1097/j.pain.0000000000000298.
citation: Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
citation: Binns-Turner PG, Wilson LL, Pryor ER, Boyd GL, Prickett CA. Perioperative music and its effects on anxiety, hemodynamics, and pain in women undergoing mastectomy. AANA J. 2011 Aug;79(4 Suppl):S21-7.
citation: Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
citation: Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.
citation: Dion LJ, Engen DJ, Lemaine V, Lawson DK, Brock CG, Thomley BS, Cha SS, Sood A, Bauer BA, Wahner-Roedler DL. Massage therapy alone and in combination with meditation for breast cancer patients undergoing autologous tissue reconstruction: A randomized pilot study. Complement Ther Clin Pract. 2016 May;23:82-7. doi: 10.1016/j.ctcp.2015.04.005. Epub 2015 May 12.
citation: Evans, H., 2019. Preoperative relaxation techniques for breast cancer patients undergoing breast-altering surgery: A systematic review. Iris J. Nurs. Care 1. https://doi.org/10.33552/ijnc.2019.01.000512
citation: Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22.
citation: Fields LM, Calvert JD. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices. Psychiatry Clin Neurosci. 2015 Aug;69(8):462-71. doi: 10.1111/pcn.12289. Epub 2015 Apr 13.
citation: Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
citation: Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
citation: Odejobi YO, Maneewat K, Chittithavorn V. Nurse-led post-thoracic surgery pain management programme: its outcomes in a Nigerian Hospital. Int Nurs Rev. 2019 Sep;66(3):434-441. doi: 10.1111/inr.12515. Epub 2019 Jul 19.