Anxiety PostoperativeNCT04277559
The Effect of Music on Postoperative Anxiety
A study testing Patient preferential music, Classical music and No music in people with Anxiety Postoperative, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Postoperative
- What is being tested?
- Patient preferential music, Classical music and No music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Oct 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergo inguinal hernia surgery under general anesthesia,
- Being the ability to speak, read and write the Turkish language
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.
Turkey (Türkiye)1 site
Dışkapı Yıldırım Beyazıt Training and Research Hospital
Ankara, Gölbaşı, 06100
About this study
Official title: Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety
In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music 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. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 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 three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.
- Conditions
- Anxiety Postoperative
- Being tested
- Patient preferential music, Classical music, No music
- Keywords
- Patient preferential music, Postoperative anxiety, Classical 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.
Classical musicOther
Patients will listen to classical music through headphones before surgery.
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 |
| Classical music | Active comparator | Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones. Receives: Other: Classical music |
| No music | Placebo comparator | the patients will not listen. 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: 4 hours
Secondary outcomes (3)
Numerical Rating Scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Measured: 24 hours
The quality of postoperative functional recovery (QoR-40) score
The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.
Measured: 24 hours
Patient satisfaction score
Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Oct 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 Anxiety PostoperativeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara Diskapi Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277559
- Sponsor's protocol ID
- music
- Status last verified
- Jan 2023
- First submitted
- 18 Feb 2020
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akelma FK, Altinsoy S, Nalbant B, Ozkan D, Ergil J. Comparison of classical and patient-preferred music on anxiety and recovery after inguinal hernia repair: a prospective randomized controlled study. Perioper Med (Lond). 2024 Aug 14;13(1):89. doi: 10.1186/s13741-024-00434-3.
PubMed 39143577
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety
- ClinicalTrials.gov ID
- NCT04277559
- Acronym / sponsor ID
- music
- Conditions
- Anxiety Postoperative
- Keywords
- Patient preferential music, Postoperative anxiety, Classical music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 20 Feb 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.
In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music 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. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 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 three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient preferential music | Active comparator | Other: Patient preferential musicThe preference of the patients will be listened to preoperatively through the headphones. |
| Classical music | Active comparator | Other: Classical musicClassical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones. |
| No music | Placebo comparator | Other: No musicthe patients will not listen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergo inguinal hernia surgery under general anesthesia,
- Being the ability to speak, read and write the Turkish language
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. | Other | Patient preferential music |
| Classical musicPatients will listen to classical music through headphones before surgery. | Other | Classical music |
| No musicPatients will not listen to music. | Other | No music |
Primary outcome
Spielberg State-Trait Anxiety Inventory (STAI) score
Time frame: 4 hours
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.
3 secondary outcomes
Numerical Rating Scale (NRS)
Time frame: 24 hours
The quality of postoperative functional recovery (QoR-40) score
Time frame: 24 hours
Patient satisfaction score
Time frame: 24 hours
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 19 May 2023.
- Derived from this study: PubMed 39143577Akelma FK, Altinsoy S, Nalbant B, Ozkan D, Ergil J. Comparison of classical and patient-preferred music on anxiety and recovery after inguinal hernia repair: a prospective randomized controlled study. Perioper Med (Lond). 2024 Aug 14;13(1):89. doi: 10.1186/s13741-024-00434-3.
- 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, Classical music and No music in people with Anxiety Postoperative, run by Ankara Diskapi Training and Research Hospital 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 2 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 19 May 2023. 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: 4 hours). 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 NCT04277559, 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 19 May 2023.