Nursing CariesnursingcareNCT04486443
Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study
A study testing music therapy in people with Nursing Caries and Pain, run by gönül düzgün at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nursing Caries, Pain, Music Therapy
- What is being tested?
- music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Aug 2018to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Nursing Caries, Pain, Music Therapy
- Being tested
- music therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyBehavioural
Also called complementary therapy
patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist from the Conservatory Department in the Ege University, using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour. All forms were applied to the group before the music therapy, respectively. Prior to musical therapy, the patient's preferred classical music (Rast or Hejaz modes) was asked by the specialist and 10 minutes of music therapy was performed according to patient's choice. Clinical data and pain scores were obtained 5, 30 and 60 minutes after music therapy. 6 sessions of music therapy were applied on different days. Patient Follow-up Form was recorded before and after each therapy. The forms were evaluated 3 times, before the application, after the 3rd and 6th application. Receives: Behavioral: music therapy |
| control group | No intervention | The control group consisted of patients who only received analgesic treatment and underwent routine nursing care, and didn't have any interventions. All forms were assessed 3 times, before application, after the 3rd application and after the 6th application. The Patient Information Form and K-MASF were applied only once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary Outcome Measure
Patient Information Form involved questions including patients' socio-demographic data.
Patient Follow-Up Form was for recording of vital signs and pain levels before and after the application.
K-MASF consisted of three parts: the nature of the pain, its severity, and general pain intensity.
GCS consisted of three levels and four dimensions. STAI was a self-assessment questionnaire consisting of short expressions. The questionnaire required patients to describe how they feel under certain conditions and to answer the scale with their feelings about these conditions.
KPC was prognostic indicator for the patient's normal activities and functional capacity.
There was a significant difference between the mean total pain scores, anxiety, comfort and functional capacityof the patients in the intervention and control groups before and after music therapy.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start9 Aug 2018
- Primary completion9 Aug 2019
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- gönül düzgün
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, gönül düzgün, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486443
- Sponsor's protocol ID
- izmirtinaztepeuni
- Acronym
- nursingcare
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Pain in Cancer Patients in Palliative Care Service: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04486443
- Acronym / sponsor ID
- nursingcare / izmirtinaztepeuni
- Conditions
- Nursing Caries, Pain, Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- gönül düzgünUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: music therapyPatients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour. All forms were applied to the group before the music therapy, respectively. Prior to musical therapy, the patient's preferred classical music (Rast or Hejaz modes) was asked by the specialist and 10 minutes of music therapy was performed according to patient's choice. Clinical data and pain scores were obtained 5, 30 and 60 minutes after music therapy. 6 sessions of music therapy were applied on different days. Patient Follow-up Form was recorded before and after each therapy. The forms were evaluated 3 times, before the application, after the 3rd and 6th application. |
| control group | No intervention | –The control group consisted of patients who only received analgesic treatment and underwent routine nursing care, and didn't have any interventions. All forms were assessed 3 times, before application, after the 3rd application and after the 6th application. The Patient Information Form and K-MASF were applied only once. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapyAlso: complementary therapypatients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist from the Conservatory Department in the Ege University, using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour. | Behavioural | Intervention Group |
Primary outcome
primary Outcome Measure
Time frame: 3 weeks
Patient Information Form involved questions including patients' socio-demographic data. Patient Follow-Up Form was for recording of vital signs and pain levels before and after the application. K-MASF consisted of three parts: the nature of the pain, its severity, and general pain intensity. GCS consisted of three levels and four dimensions. STAI was a self-assessment questionnaire consisting of short expressions. The questionnaire required patients to describe how they feel under certain conditions and to answer the scale with their feelings about these conditions. KPC was prognostic indicator for the patient's normal activities and functional capacity. There was a significant difference between the mean total pain scores, anxiety, comfort and functional capacityof the patients in the intervention and control groups before and after music therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Nursing Caries and Pain, run by gönül düzgün at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary Outcome Measure (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.