Orthopedic SurgeryNCT05424211
The Effect of Music Therapy on Pain Level and Analgesic Consumption
A study testing Music Therapy Mobile Application in people with Orthopedic Surgery and Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Pain is a common condition experienced by patients in long-term health care, rehabilitation and acute situations, due to various surgical interventions and invasive procedures, and postoperative pain is an important symptom experienced by patients during the surgical recovery process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, Pain, Postoperative, Analgesia
- What is being tested?
- Music Therapy Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 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
- Accepting to participate in the study, being over the age of 18, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being able to read and write
Who cannot join
- Being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of A Mobile Application-Based Music Intervention On Pain Levels And Analgesic Consumption Following Surgery: A Randomized Controlled Trial
Pain is a common condition experienced by patients in long-term health care, rehabilitation and acute situations, due to various surgical interventions and invasive procedures, and postoperative pain is an important symptom experienced by patients during the surgical recovery process. The International Association for the Study of Pain (IASP) defines pain as an unpleasant emotional experience associated with actual or potential tissue damage (Lok, Ibrahim and Sidani 2020; Çavdar and Akyüz 2017; Martin-Saavedra, Vergara-Mendez, Talero-Gutiérrez 2018). Orthopedic surgical interventions are considered to be one of the most painful surgical procedures, and pain control requires a multifaceted approach that includes non-pharmacological techniques (Allred et al. 2010). Music therapy, which is one of the non-traditional treatment methods, is used to reduce pain (Nilson 2008). Music can easily be included in nursing care because it is applied without the physician's request and causes very little legal and ethical concerns (Simcock et al. 2008). However, due to the lack of awareness about the effectiveness of music therapy, it is not often used as an intervention. Inadequate pain control causes a decrease in patient satisfaction and deterioration of the healing process (Lukas 2004). Therefore, this study was planned as a randomized controlled experimental study to determine the effect of music therapy on the pain level of patients undergoing orthopedic surgery.
Read the detailed description
This study was planned as a randomized controlled experimental study to determine the effect of music therapy on the level of pain after orthopedic surgery. The population of the research will consist of patients who have undergone orthopedic surgery in the orthopedic service of a university hospital. In a similar study in the literature (Tolunay et al. 2018), the number of samples was calculated on the basis of 95% confidence interval, 80% power level, 0.05 error level, 0.84 effect level, considering the pain averages of the experimental and control groups. As a result of the power analysis, at least 19 patients were included in the experimental and control groups, and it was determined that a total of at least 38 patients could form the sample group; however, it was decided to complete the study with a total of 80 patients by assigning 40 patients to each group so that parametric tests could be performed during the data analysis.
Inclusion criteria for the study: Accepting to participate in the study, being over 18 years old, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being literate.
Exclusion criteria for the study: being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.
Data will be collected by Patient Information Form, Numerical Scale (NRS) and Short Form.
Implementation of Research:
First stage: All patients who meet the sampling criteria will be informed about the type, purpose and application process of the pre-intervention study, and written and verbal consent will be obtained for participation. In order to prevent individuals from being informed about the interventions, the participants will be randomized to the experimental and control groups according to the period of admission to the hospital. According to the results of randomization, patients will be assigned to the group (experimental group) and the control group. Researchers will maintain the confidentiality of patients' identity and study-related information using serial numbers.
Second stage: After the explanations about the study are made and the necessary written and verbal consent is obtained, a structured information form containing information about socio-demographic variables such as age, gender, education, alcohol and smoking use, chronic disease of all participants will be filled.
Third stage:
Music Therapy Mobile Application: The authorities determined by consulting TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon. Each patient will be given a personal headphone probe to listen to music.
Pain assessment will be done with NRS before and immediately after the application. Routine treatment and care of the patients in the control group will continue.
- Conditions
- Orthopedic Surgery, Pain, Postoperative, Analgesia
- Being tested
- Music Therapy Mobile Application
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy Mobile ApplicationDevice
The authorities determined by taking consultancy from TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | the group using the music therapy mobile application Receives: Device: Music Therapy Mobile Application |
| control group | No intervention | the group that received routine care and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NRS)
It starts with the absence of pain (0) on numerical scales and reaches the level of unbearable pain (10-100). Numerical scales are used by patients to facilitate the definition of pain intensity, to facilitate scoring and recording, and to evaluate ceiling and floor effects.
Measured: 1 year
Secondary outcomes (1)
Analgesic consumption amount
The amount of analgesic used by the patients after the surgery will be recorded in the table.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start2 May 2021
- Primary completion1 Apr 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 Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acelya Turkmen, Cukurova University
- Investigators
- Açelya Türkmen, PhD, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424211
- Sponsor's protocol ID
- CU-SBF-AT-03
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkmen A, Ozhanli Y, Cavdar I, Erden S, Tura I, Basibuyuk IF, Canikoglu M. The effect of a mobile application-based music intervention on pain levels and analgesic consumption following surgery: a randomized controlled trial. Rev Assoc Med Bras (1992). 2026 Jun 29;72(4):e20251930. doi: 10.1590/1806-9282.20251930. eCollection 2026.
PubMed 42385045
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of A Mobile Application-Based Music Intervention On Pain Levels And Analgesic Consumption Following Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05424211
- Acronym / sponsor ID
- CU-SBF-AT-03
- Conditions
- Orthopedic Surgery, Pain, Postoperative, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 21 Jun 2022 (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.
Pain is a common condition experienced by patients in long-term health care, rehabilitation and acute situations, due to various surgical interventions and invasive procedures, and postoperative pain is an important symptom experienced by patients during the surgical recovery process. The International Association for the Study of Pain (IASP) defines pain as an unpleasant emotional experience associated with actual or potential tissue damage (Lok, Ibrahim and Sidani 2020; Çavdar and Akyüz 2017; Martin-Saavedra, Vergara-Mendez, Talero-Gutiérrez 2018). Orthopedic surgical interventions are considered to be one of the most painful surgical procedures, and pain control requires a multifaceted approach that includes non-pharmacological techniques (Allred et al. 2010). Music therapy, which is one of the non-traditional treatment methods, is used to reduce pain (Nilson 2008). Music can easily be included in nursing care because it is applied without the physician's request and causes very little legal and ethical concerns (Simcock et al. 2008). However, due to the lack of awareness about the effectiveness of music therapy, it is not often used as an intervention. Inadequate pain control causes a decrease in patient satisfaction and deterioration of the healing process (Lukas 2004). Therefore, this study was planned as a randomized controlled experimental study to determine the effect of music therapy on the pain level of patients undergoing orthopedic surgery.
Detailed description
This study was planned as a randomized controlled experimental study to determine the effect of music therapy on the level of pain after orthopedic surgery. The population of the research will consist of patients who have undergone orthopedic surgery in the orthopedic service of a university hospital. In a similar study in the literature (Tolunay et al. 2018), the number of samples was calculated on the basis of 95% confidence interval, 80% power level, 0.05 error level, 0.84 effect level, considering the pain averages of the experimental and control groups. As a result of the power analysis, at least 19 patients were included in the experimental and control groups, and it was determined that a total of at least 38 patients could form the sample group; however, it was decided to complete the study with a total of 80 patients by assigning 40 patients to each group so that parametric tests could be performed during the data analysis.
Inclusion criteria for the study: Accepting to participate in the study, being over 18 years old, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being literate.
Exclusion criteria for the study: being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.
Data will be collected by Patient Information Form, Numerical Scale (NRS) and Short Form.
Implementation of Research:
First stage: All patients who meet the sampling criteria will be informed about the type, purpose and application process of the pre-intervention study, and written and verbal consent will be obtained for participation. In order to prevent individuals from being informed about the interventions, the participants will be randomized to the experimental and control groups according to the period of admission to the hospital. According to the results of randomization, patients will be assigned to the group (experimental group) and the control group. Researchers will maintain the confidentiality of patients' identity and study-related information using serial numbers.
Second stage: After the explanations about the study are made and the necessary written and verbal consent is obtained, a structured information form containing information about socio-demographic variables such as age, gender, education, alcohol and smoking use, chronic disease of all participants will be filled.
Third stage:
Music Therapy Mobile Application: The authorities determined by consulting TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon. Each patient will be given a personal headphone probe to listen to music.
Pain assessment will be done with NRS before and immediately after the application. Routine treatment and care of the patients in the control group will continue.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Device: Music Therapy Mobile Applicationthe group using the music therapy mobile application |
| control group | No intervention | –the group that received routine care and treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Accepting to participate in the study, being over the age of 18, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being able to read and write
Key exclusion criteria (1 listed)
- Being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.
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 Therapy Mobile ApplicationThe authorities determined by taking consultancy from TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon. | Device | Music group |
Primary outcome
The Numerical Rating Scale (NRS)
Time frame: 1 year
It starts with the absence of pain (0) on numerical scales and reaches the level of unbearable pain (10-100). Numerical scales are used by patients to facilitate the definition of pain intensity, to facilitate scoring and recording, and to evaluate ceiling and floor effects.
1 secondary outcome
Analgesic consumption amount
Time frame: 1 year
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 9 May 2025.
- Derived from this study: PubMed 42385045Turkmen A, Ozhanli Y, Cavdar I, Erden S, Tura I, Basibuyuk IF, Canikoglu M. The effect of a mobile application-based music intervention on pain levels and analgesic consumption following surgery: a randomized controlled trial. Rev Assoc Med Bras (1992). 2026 Jun 29;72(4):e20251930. doi: 10.1590/1806-9282.20251930. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Orthopedic Surgery
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
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.
Açelya Türkmen, PhD study chair
Cukurova University
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 Mobile Application in people with Orthopedic Surgery and Pain, Postoperative, run by Cukurova 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 9 May 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?
The Numerical Rating Scale (NRS) (time frame: 1 year). 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 NCT05424211, 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 9 May 2025.