Pain, ChronicNCT06285383
The Effects of Music on Neck Pain
A study testing Music listening and classic physical therapy in people with Pain, Chronic, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Music listening and classic physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2024to 15 Jul 2024
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with neck pain for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (VAS)
Who cannot join
- individuals who regularly take painkillers or anti-depressant and cortisone; and individuals having severe chronic illness and spine surgery were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Savaş Torlak
Karatay, Eyalet/Yerleşke, 42000
About this study
Official title: The Effect of Listening to Music in Addition to Physiotherapy on Pain, Anxiety and Quality of Life in Patients With Chronic Neck Pain
The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined.
Read the detailed description
The aim of the study was to investigate the effects of passive music listening in addition to physical therapy on pain, anxiety and quality of life in patients with chronic neck pain.There is no study in the literature examining the relationship between music listening and physical therapy in chronic back pain. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.
- Conditions
- Pain, Chronic
- Being tested
- Music listening, classic physical therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music listeningOther
Participants will listen to the music pieces Pachabel Canon in D major (30 minutes), free from external sounds (max 70 dB through headphones).
classic physical therapyOther
classic physical therapy
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Participants in the control group will receive classical physiotherapy 5 days a week for 4 weeks (Tens 20 min, ultrasound 5 min, hotpack 20 min). Receives: Other: classic physical therapy |
| Music group | Experimental | Participants in the music group will be played Pachabel Canon D major (30 minutes) during the classical physical therapy session, free from external sounds (max 70 dB through headphones). Receives: Other: Music listening; Other: classic physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck anxiety inventory
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Measured: baseline and 4 weeks
Visual Analogue Scale
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Measured: baseline and 4 weeks
Short form-36
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.
It comprises 36 questions that cover eight domains of health:
Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285383
- Sponsor's protocol ID
- Kar.neck
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music in Addition to Physiotherapy on Pain, Anxiety and Quality of Life in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06285383
- Acronym / sponsor ID
- Kar.neck
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 29 Feb 2024 (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.
The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined.
Detailed description
The aim of the study was to investigate the effects of passive music listening in addition to physical therapy on pain, anxiety and quality of life in patients with chronic neck pain.There is no study in the literature examining the relationship between music listening and physical therapy in chronic back pain. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: classic physical therapyParticipants in the control group will receive classical physiotherapy 5 days a week for 4 weeks (Tens 20 min, ultrasound 5 min, hotpack 20 min). |
| Music group | Experimental | Other: Music listening, Other: classic physical therapyParticipants in the music group will be played Pachabel Canon D major (30 minutes) during the classical physical therapy session, free from external sounds (max 70 dB through headphones). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with neck pain for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (VAS)
Key exclusion criteria (1 listed)
- individuals who regularly take painkillers or anti-depressant and cortisone; and individuals having severe chronic illness and spine surgery were excluded from 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 listeningParticipants will listen to the music pieces Pachabel Canon in D major (30 minutes), free from external sounds (max 70 dB through headphones). | Other | Music group |
| classic physical therapyclassic physical therapy | Other | Music group, control group |
Primary outcome
Beck anxiety inventory
Time frame: baseline and 4 weeks
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Visual Analogue Scale
Time frame: baseline and 4 weeks
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.
Short form-36
Time frame: baseline and 4 weeks
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions
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 17 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 listening and classic physical therapy in people with Pain, Chronic, run by KTO Karatay 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 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 17 Oct 2024. 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?
Beck anxiety inventory (time frame: baseline and 4 weeks). The study lists 3 primary outcomes in all. 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 17 Oct 2024.