Music Intervention for Preoperative Anxiety and Acute Pain Among Mastectomy Patients

NCT04824183 | Completed

• 1 other identifier: 2021.127
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 3

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.

Conditions

Breast Cancer; Mastectomy; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Change in acute postoperative pain intensity

  The Visual Analogue Scale will be used to assess the pain intensity level. The score on this scale ranged from 0 to 10, higher score represents high pain intensity

  Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery

Secondary Outcomes (6)

• Change in preoperative anxiety

  Pre-intervention and immediately after the intervention on the day of surgery

• Change in blood pressure

  Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery

• Analgesia consumption

  Post-intervention at 48 hours after surgery

• Satisfaction with pain management

  Immediately after intervention at 48 hours after surgery

• Change in heart rate

  Pre-intervention and immediately after the intervention through study completion at 48 hours after surgery

Study Arms (2)

Music intervention

EXPERIMENTAL

Music intervention that begins with patient education on WhatsApp will be delivered to participants 3 times within 48 hours before surgery followed by face-to-face monitoring of intervention usage.

Other: Music intervention

Usual care

NO INTERVENTION

Participants in the control group will receive preoperative pain education via a one-on-one WhatsApp chat. The pain education will focus mainly on the type of pain to expect after surgery, how to report pain and how to request pain medication. MI will not be introduced to the participants in this group neither will there be any phone call for psychological support. Other preoperative care and postoperative care will be provided according to the hospital and ward practices.

Interventions

Music intervention OTHER

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.

Also known as: Hybrid-mode delivered music intervention

Music intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Women aged 18 and above diagnosed with breast cancer and undergoing mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (3)

Kamuzu Central Hospital

Lilongwe, Malawi

Location

Lagos State University Teaching Hospital

Ikeja, Lagos, 23401, Nigeria

Location

Lagos University Teaching Hospital

Lagos, Nigeria

Location

Related Publications (13)

• 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

  BACKGROUND

• 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.

  PMID: 26176893 BACKGROUND

• 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.

  PMID: 11733293 BACKGROUND

• 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.

  PMID: 22403963 BACKGROUND

• 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.

  PMID: 26827847 BACKGROUND

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• 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.

  PMID: 25986296 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 19453965 BACKGROUND

• 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.

  PMID: 25756740 BACKGROUND

• 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.

  PMID: 29026331 BACKGROUND

• 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.

  PMID: 20400379 BACKGROUND

• 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.

  PMID: 31322292 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ka Ming Chow, DN

  The Nethersole School of Nursing, Chinese University of Hong Kong

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-blind multicenter randomised controlled trial

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: June 5, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 27, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1); NG (2)