Clinical trial · Interventional
Music Intervention for Preoperative Anxiety and Acute Pain Among Mastectomy Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Mastectomy | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music intervention
- description
- 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.
- interventionNames
- Other: Music intervention
- type
- NO_INTERVENTION
- label
- Usual care
- description
- 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.
Primary outcomes (1)
- measure
- Change in acute postoperative pain intensity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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. \-
References
Publications (13)
- BACKGROUNDAnagnostopoulos, 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
- BACKGROUNDAndersen 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
- BACKGROUNDBijur 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
- BACKGROUNDBinns-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
- BACKGROUNDChou 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
- BACKGROUNDCohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155. PMID 19565683
- BACKGROUNDDion 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.