CancerNCT07262151
Effect of Music on Pain and Anxiety in Palliative Cancer Patients
A study testing Music Application in people with Cancer and Cancer Pain, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Background: Cancer patients receiving palliative care often endure a variety of distressing symptoms, most notably pain and anxiety. Evidence suggests that music offers a symptom-alleviating effect for these patients and can also influence their physiological parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Pain, Palliative Care
- What is being tested?
- Music Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Jun 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cancer
- Receiving palliative care treatment at Yozgat City Hospital or Karaman Training and Research Hospital
- Hospitalized in the palliative care center for at least 7 days
- Aged 18 years or older
- Able to speak and understand Turkish
- Able to communicate verbally
Show all 12Show fewer
- Oriented to place and time
- No psychiatric disease
- No vision or hearing problems
- Self-reported pain intensity of at least 3 on the Visual Analog Scale in the last 24 hours
- Voluntarily agreed to participate in the study
- Provided written informed consent
Who cannot join
- Underwent major surgical intervention within the last month
- Currently using another complementary and integrative treatment (e.g., aromatherapy, acupuncture)
- Cognitive impairment preventing questionnaire completion
- Not open to communication
- Died within seven days of hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Determination of the Effect of Music on Pain, Anxiety, and Vital Findings in Cancer Patients Treated in Palliative Care Centers : a Quasi-experimental Study
Background: Cancer patients receiving palliative care often endure a variety of distressing symptoms, most notably pain and anxiety. Evidence suggests that music offers a symptom-alleviating effect for these patients and can also influence their physiological parameters.
Aim: This investigation was structured as a quasi-experimental study utilizing a pre-test and post-test design with a control group. Its goal was to ascertain the influence of music on pain levels, anxiety states, and vital signs among cancer patients admitted to a palliative care facility.
Methods: Data collection relied on the Patient Demographic Form, the Visual Analog Scale (VAS), the State-Trait Anxiety Inventory (STAI), and a Physiological Parameter Monitoring Form. The intervention group was exposed to relaxing instrumental Turkish music in the maqams of Hicaz and Buselik for a single 30-minute session using MP3 players and headphones, whereas the control group was instructed to observe 30 minutes of bed rest without any other activity. Measurements were taken at baseline (pre-intervention) and immediately after the 30-minute intervention period between 10:00 AM and 5:00 PM following the patient's morning analgesic dose.
Read the detailed description
Advances in medicine have increased life expectancy, leading to a rise in chronic diseases like cancer, with 14 million new cases annually, projected to reach 22 million by 2030. Cancer patients often face intensive treatments and severe symptoms, including pain and anxiety, highlighting the need for palliative care.
Nurses play a key role in symptom management, using both pharmacological and non-pharmacological methods, including music therapy. Music can stimulate neuroendocrine responses by increasing dopamine and serotonin release, activating the limbic system, increasing endorphin release, and suppressing sympathetic nervous system activity, which contributes significantly to reducing pain and anxiety while also affecting the regulation of vital signs such as blood pressure, pulse, body temperature, respiratory rate, and oxygen saturation.
This study examined the effects of music on pain, anxiety, and vital signs in 32 palliative care cancer patients using a quasi-experimental design with a pretest-posttest control group. The study was conducted between February 2021 and June 2022 at Yozgat City Hospital Palliative Care Center and Karaman Training and Research Hospital Palliative Care Center.
Patients in the intervention group listened to 30 minutes of instrumental Turkish music in the maqams of Hicaz and Buselik; controls rested quietly. The music CD was prepared by experts from the Applied Music Therapy Association (UMTED) and consisted of 13 instrumental works designed to provide relaxation and have a sedative effect. The volume was kept low and the main melody was emphasized.
Data collection took approximately 60 minutes per participant. The intervention was performed between 10:00 AM and 5:00 PM after patients received their first daily analgesic dose. Headphones were used to maintain focus and block extraneous noise, with separate devices for each patient to ensure infection control standards. Further research should explore mechanisms, patient differences, and optimal implementation protocols.
- Conditions
- Cancer, Cancer Pain, Palliative Care, Anxiety, Music Therapy
- Being tested
- Music Application, Procedures for the Control Group
- Keywords
- Anxiety, Cancer, Music, Pain, Palliative care, Vital signs
- Medical subject headings
- Neoplasms, Cancer Pain, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ApplicationOther
Before the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2).
The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded.
Procedures for the Control GroupOther
The control group followed the same two-phase data collection protocol as the intervention group (first follow-up). After baseline data collection, the control group was instructed to rest quietly in bed for 30 minutes without any other activity. Immediately after the rest period (second follow-up), the VAS, State Anxiety Inventory, and vital signs were measured and recorded.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | Before the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2).
The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded. Receives: Other: Music Application |
| Control Group | Other | Procedures for the Control Group Receives: Other: Procedures for the Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Visual Analog Scale
A standard 10 cm tool (Price et al., 1983) where patients mark their current pain level (0 = no pain, 10 = worst possible pain).
Measured: Baseline (Pre-Intervention) and Immediately Post-Intervention (Total 30-minute intervention period).
Secondary outcomes (2)
State Anxiety (State-Trait Anxiety Inventory - State Subscale)
Developed by Spielberger et al. (1970) and validated for Turkish by Öner and Le Compte (1985). This inventory measures transient (State) anxiety; higher scores indicate higher anxiety. Scores range from 20 to 80. Internal consistency (Cronbach's alpha) in this study was 0.81 for State Anxiety.
Measured: Baseline (Pre-Intervention) and Immediately After Intervention (30-minute intervention period).
Trait Anxiety (State-Trait Anxiety Inventory - Trait Subscale)
Developed by Spielberger et al. (1970) and validated for Turkish by Öner and Le Compte (1985). This inventory measures general (Trait) anxiety; higher scores indicate higher anxiety. Scores range from 20 to 80. Internal consistency (Cronbach's alpha) in this study was 0.76 for Trait Anxiety.
Measured: Baseline (Pre-Intervention) only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Feb 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsüm Kehribar, Karamanoğlu Mehmetbey University
- Investigators
- Pınar Tekinsoy Kartın, Principal investigator, https://sbf.erciyes.edu.tr/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262151
- Sponsor's protocol ID
- KMU-SHMYO-GK-01
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Witte M, Pinho ADS, Stams GJ, Moonen X, Bos AER, van Hooren S. Music therapy for stress reduction: a systematic review and meta-analysis. Health Psychol Rev. 2022 Mar;16(1):134-159. doi: 10.1080/17437199.2020.1846580. Epub 2020 Nov 27.
PubMed 33176590
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of the Effect of Music on Pain, Anxiety, and Vital Findings in Cancer Patients Treated in Palliative Care Centers : a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07262151
- Acronym / sponsor ID
- KMU-SHMYO-GK-01
- Conditions
- Cancer, Cancer Pain, Palliative Care, Anxiety, Music Therapy
- Keywords
- Anxiety, Cancer, Music, Pain, Palliative care, Vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 3 Dec 2025 (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: Cancer patients receiving palliative care often endure a variety of distressing symptoms, most notably pain and anxiety. Evidence suggests that music offers a symptom-alleviating effect for these patients and can also influence their physiological parameters.
Aim: This investigation was structured as a quasi-experimental study utilizing a pre-test and post-test design with a control group. Its goal was to ascertain the influence of music on pain levels, anxiety states, and vital signs among cancer patients admitted to a palliative care facility.
Methods: Data collection relied on the Patient Demographic Form, the Visual Analog Scale (VAS), the State-Trait Anxiety Inventory (STAI), and a Physiological Parameter Monitoring Form. The intervention group was exposed to relaxing instrumental Turkish music in the maqams of Hicaz and Buselik for a single 30-minute session using MP3 players and headphones, whereas the control group was instructed to observe 30 minutes of bed rest without any other activity. Measurements were taken at baseline (pre-intervention) and immediately after the 30-minute intervention period between 10:00 AM and 5:00 PM following the patient's morning analgesic dose.
Detailed description
Advances in medicine have increased life expectancy, leading to a rise in chronic diseases like cancer, with 14 million new cases annually, projected to reach 22 million by 2030. Cancer patients often face intensive treatments and severe symptoms, including pain and anxiety, highlighting the need for palliative care.
Nurses play a key role in symptom management, using both pharmacological and non-pharmacological methods, including music therapy. Music can stimulate neuroendocrine responses by increasing dopamine and serotonin release, activating the limbic system, increasing endorphin release, and suppressing sympathetic nervous system activity, which contributes significantly to reducing pain and anxiety while also affecting the regulation of vital signs such as blood pressure, pulse, body temperature, respiratory rate, and oxygen saturation.
This study examined the effects of music on pain, anxiety, and vital signs in 32 palliative care cancer patients using a quasi-experimental design with a pretest-posttest control group. The study was conducted between February 2021 and June 2022 at Yozgat City Hospital Palliative Care Center and Karaman Training and Research Hospital Palliative Care Center.
Patients in the intervention group listened to 30 minutes of instrumental Turkish music in the maqams of Hicaz and Buselik; controls rested quietly. The music CD was prepared by experts from the Applied Music Therapy Association (UMTED) and consisted of 13 instrumental works designed to provide relaxation and have a sedative effect. The volume was kept low and the main melody was emphasized.
Data collection took approximately 60 minutes per participant. The intervention was performed between 10:00 AM and 5:00 PM after patients received their first daily analgesic dose. Headphones were used to maintain focus and block extraneous noise, with separate devices for each patient to ensure infection control standards. Further research should explore mechanisms, patient differences, and optimal implementation protocols.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Other: Music ApplicationBefore the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2). The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded. |
| Control Group | Other | Other: Procedures for the Control GroupProcedures for the Control Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosed with cancer
- Receiving palliative care treatment at Yozgat City Hospital or Karaman Training and Research Hospital
- Hospitalized in the palliative care center for at least 7 days
- Aged 18 years or older
- Able to speak and understand Turkish
Key exclusion criteria (5 listed)
- Underwent major surgical intervention within the last month
- Currently using another complementary and integrative treatment (e.g., aromatherapy, acupuncture)
- Cognitive impairment preventing questionnaire completion
- Not open to communication
- Died within seven days of hospital admission
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 ApplicationBefore the single-session intervention, the researcher administered the Patient Description Form, STAI, and VAS, and recorded baseline vital signs (Blood Pressure, Pulse Rate, Respiratory Rate, Body Temperature, SpO2). The intervention was scheduled between 10:00 a.m. and 5:00 p.m. following the patient's morning analgesic dose. Participants rested comfortably for 30 minutes while listening to music using an MP3 player and headphones. Headphones were used to enhance focus and minimize external noise, with separate devices used for each patient to adhere to infection control standards. Immediately post-intervention (second follow-up), VAS, State Anxiety Inventory, and vital signs were re-measured and recorded. | Other | Music Intervention Group |
| Procedures for the Control GroupThe control group followed the same two-phase data collection protocol as the intervention group (first follow-up). After baseline data collection, the control group was instructed to rest quietly in bed for 30 minutes without any other activity. Immediately after the rest period (second follow-up), the VAS, State Anxiety Inventory, and vital signs were measured and recorded. | Other | Control Group |
Primary outcome
• Visual Analog Scale
Time frame: Baseline (Pre-Intervention) and Immediately Post-Intervention (Total 30-minute intervention period).
A standard 10 cm tool (Price et al., 1983) where patients mark their current pain level (0 = no pain, 10 = worst possible pain).
2 secondary outcomes
State Anxiety (State-Trait Anxiety Inventory - State Subscale)
Time frame: Baseline (Pre-Intervention) and Immediately After Intervention (30-minute intervention period).
Trait Anxiety (State-Trait Anxiety Inventory - Trait Subscale)
Time frame: Baseline (Pre-Intervention) only.
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 3 Dec 2025.
- Background: PubMed 33176590de Witte M, Pinho ADS, Stams GJ, Moonen X, Bos AER, van Hooren S. Music therapy for stress reduction: a systematic review and meta-analysis. Health Psychol Rev. 2022 Mar;16(1):134-159. doi: 10.1080/17437199.2020.1846580. Epub 2020 Nov 27.
- Individual participant dataSharing planned: No
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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.
Pınar Tekinsoy Kartın principal investigator
https://sbf.erciyes.edu.tr/
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 Application in people with Cancer and Cancer Pain, run by Karamanoğlu Mehmetbey University 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 12 inclusion and 5 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 3 Dec 2025. 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?
• Visual Analog Scale (time frame: Baseline (Pre-Intervention) and Immediately Post-Intervention (Total 30-minute intervention period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262151, which also lists 1 linked publication.
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 3 Dec 2025.