Anxiety PostoperativeNCT06764407
The Effect of Music on Postoperative Anxiety
A study testing Patient preferential music and No Music in people with Anxiety Postoperative and Quality of Recovery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Postoperative, Quality of Recovery
- What is being tested?
- Patient preferential music and No Music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2025to 1 Apr 2025
- 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
- Undergo Total Knee Arthroplasty Under Spinal Anesthesia
Who cannot join
- Poor vision
- Significant hearing loss
- Dementia
- Active opioid use
- Regular use of anxiolytics or discontinuation of them on the day of surgery
- Unwillingness to participate in the study
- Unwillingness to listening to music
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Patient Preferred Music on Postoperative Anxiety
In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.
Read the detailed description
Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 80 patients scheduled for total knee arthroplasty surgery for will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as listening patient preferential music, and control. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.Secondary aim is to assess the effect of listening patient preferred music on Quality of recovery, postoperative pain, MCID (minimal clinically important diffirence), patient and surgeon satisfaction.
- Conditions
- Anxiety Postoperative, Quality of Recovery
- Being tested
- Patient preferential music, No Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient preferential musicOther
Patients will listen to their preferred music through the headphones before surgery and intraoperative period.
No MusicOther
Patients will not listen to music.
| Study group | Role | What they receive |
|---|---|---|
| Patient preferential music | Active comparator | The preference of the patients will be listened to preoperatively through the headphones. Receives: Other: Patient preferential music |
| No Music | Placebo comparator | Patients will not listen to music. Receives: Other: No Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberg State-Trait Anxiety Inventory (STAI) score
The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.
Measured: Preoperative 1st hour and Postoperative 4th hour
Secondary outcomes (5)
Numerical Rating Scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Measured: Postoperative 4th, 12th and 24th hours
The quality of postoperative functional recovery (QoR-15) score
The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
Measured: Preoperative 1st hour and Postoperative 24th hour
Patient satisfaction score
Patients were asked about their satisfaction levels with a number between 0-10.
Measured: Postoperative 24th hour
MCID of STAI score
Calculation of the MCID of the STAI score
Measured: 24 hour
MCID of QoR-15 score
Calculation of the MCID of the QoR-15 score
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start9 Jan 2025
- Primary completion3 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak NALBANT, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764407
- Sponsor's protocol ID
- 33
- Status last verified
- May 2025
- First submitted
- 2 Jan 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kavak Akelma F, Altinsoy S, Arslan MT, Ergil J. Effect of favorite music on postoperative anxiety and pain. Anaesthesist. 2020 Mar;69(3):198-204. doi: 10.1007/s00101-020-00731-8. Epub 2020 Feb 11.
PubMed 32047952Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
PubMed 23740695
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Preferred Music on Postoperative Anxiety
- ClinicalTrials.gov ID
- NCT06764407
- Acronym / sponsor ID
- 33
- Conditions
- Anxiety Postoperative, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 8 Jan 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.
In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.
Detailed description
Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 80 patients scheduled for total knee arthroplasty surgery for will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into two groups as listening patient preferential music, and control. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.Secondary aim is to assess the effect of listening patient preferred music on Quality of recovery, postoperative pain, MCID (minimal clinically important diffirence), patient and surgeon satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient preferential music | Active comparator | Other: Patient preferential musicThe preference of the patients will be listened to preoperatively through the headphones. |
| No Music | Placebo comparator | Other: No MusicPatients will not listen to music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergo Total Knee Arthroplasty Under Spinal Anesthesia
Key exclusion criteria (7 listed)
- Poor vision
- Significant hearing loss
- Dementia
- Active opioid use
- Regular use of anxiolytics or discontinuation of them on the day of surgery
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 |
|---|---|---|
| Patient preferential musicPatients will listen to their preferred music through the headphones before surgery and intraoperative period. | Other | Patient preferential music |
| No MusicPatients will not listen to music. | Other | No Music |
Primary outcome
Spielberg State-Trait Anxiety Inventory (STAI) score
Time frame: Preoperative 1st hour and Postoperative 4th hour
The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.
5 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: Postoperative 4th, 12th and 24th hours
The quality of postoperative functional recovery (QoR-15) score
Time frame: Preoperative 1st hour and Postoperative 24th hour
Patient satisfaction score
Time frame: Postoperative 24th hour
MCID of STAI score
Time frame: 24 hour
MCID of QoR-15 score
Time frame: 24 hour
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 28 May 2025.
- Background: PubMed 32047952Kavak Akelma F, Altinsoy S, Arslan MT, Ergil J. Effect of favorite music on postoperative anxiety and pain. Anaesthesist. 2020 Mar;69(3):198-204. doi: 10.1007/s00101-020-00731-8. Epub 2020 Feb 11.
- Background: PubMed 23740695Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
- 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.
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 Patient preferential music and No Music in people with Anxiety Postoperative and Quality of Recovery, run by Ankara City Hospital Bilkent 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 7 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 28 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. Some participants in this study may receive a placebo. 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?
Spielberg State-Trait Anxiety Inventory (STAI) score (time frame: Preoperative 1st hour and Postoperative 4th hour). 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 NCT06764407, which also lists 2 linked publications.
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 28 May 2025.