Clinical trial NCT04486443: Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study
Official title: Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Pain
Music Therapy
Lead sponsor: Izmir Tinaztepe University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants individually randomised to one of two "parallel" groups (Özdemir O 2009). It was considered sufficient to select the participants in the intervention and control groups with the similar 3-4 variables including age and gender (Büyüköztürk Ş 2016). Therefore, patients in the intervention and control groups were randomized according to age, gender and disease stage. The coin tossing method was used to determine which group the patients would involve in. All patients continued to use all medications prescribed before, during and after the research, and no interventions and changes were performed to the patients in this regard. Pain scores of all patients were at 3 and above and they received narcotic analgesics. Researcher generated the allocation sequence, enrolled participants, and assigned participants to interventions.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Palliative care services can be applied in chronic, life-threatening conditions such as cancer, and provide physical, mental and psychological support to patients worldwide. Purpose: This study aimed to investigate the effect of music on pain, anxiety, comfort and functional capacity of cancer patients received care in a palliative care unit.

Methods: The population of this randomized controlled trial consisted of cancer patients hospitalized in the Palliative Care Service of a Training and Research Hospital between July 2018-July 2019. The sample of the study included 60 patients (30 interventions/30 controls) who met the inclusion criteria. The patients in the intervention group were given a total of six music sessions, ten minutes each with the Turkish classical music in maqams (modes) of their choice (Hejaz or Rast accompanied by an expert tambour (drum) player).

Detailed description: The incidence of chronic diseases and conditions including cancer that require a long-term treatment process and also affect the individual psychological status and quality of life has increased with a high financial burden as a result of relatively prolonged human life under the influence of contemporary medicine. Palliative care services can be applied in chronic, life-threatening conditions such as cancer, and provide physical, mental and psychological support to patients worldwide. Symptoms including pain, constipation, diarrhea, anorexia, dysphagia, nausea and vomiting, dehydration, depression, delirium, and fatigue may demonstrate in cancer patients receiving palliative care, while most of the them have complain of pain. Studies have reported that 30% of cancer patients experienced pain at the diagnosis, 50-70% of them in during treatment period, and 60-80% of them in the terminal period. It was determined in another study that 90% of patients had pain when they were hospitalized in palliative care service, and more than half of them defined the pain severity at 5 and above.

Pharmacological agents were used to manage pain control, as they had rapid effect and were easily applicable. In addition to pharmacological agents, the application of non-pharmacological interventions is important for improving the quality of life and patient comfort and reducing the symptom burden in relieving pain caused by the side effects and methods of treatment in the palliative care cancer patients. Since non-pharmacological methods could reduce pain by applying alone or in combination with drugs, the frequency of use has increased in recent years. Music therapy was used as a non-pharmacological method in many health problems as a traditional treatment and psychosocial interventions. The study was aimed to investigate the effects of music therapy on pain in patients with cancer hospitalized palliative care service. In the current study we tested the hypothesis that palliative care patients' pain management. 1. reduce the rate of pain score. 2. reduce the rate of anxiety scoe. 3. To increase the rate of comfort level. 4. To increase the rate of functional capacity.

Eligibility criteria: Inclusion Criteria:

* Patients who were older than 18 years old, speaking and understanding Turkish language, volunteering to participate in the study, diagnosed with cancer and hospitalized in a palliative care service, defined "moderate" or "severe" pain (\>3 Visual Analog Scale scores) despite using opioid or analgesic, not in the terminal period, and not in bedridden status were included the study. Also, patients without cognitive impairment or brain metastases, and without clinical diagnosis or findings of dementia, hearing problems, agitation or delirium were enrolled the study.

Exclusion Criteria:

* Patients who were younger than 18 years old, not know speaking and understanding Turkish language, not to be volunteering to participate in the study, not diagnosed with cancer and not hospitalized in a palliative care service, Visual Analog Scale scores lower than 3 point, in the terminal period, and in bedridden status and patients with cognitive impairment or brain metastases, and with clinical diagnosis or findings of dementia, hearing problems, agitation or delirium weren't included the study.

Primary outcomes:
measure: primary Outcome Measure
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gönül Düzgün
state: Konak
Study officials:
References: