Music on Postoperative AnxietyNCT03816501
Effect of Preoperative Music on Anxiety
A study testing music and no music in people with Music on Postoperative Anxiety, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to 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
- Music on Postoperative Anxiety
- What is being tested?
- music and no music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 15 May 2019
- 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
- inguinal hernia surgery
- speak Turkish language
Who cannot join
- Patients with dementia and psychiatric disorders
- anxiolytic and psychiatric drug users
- patients without written consent
- poor vision,
- significant hearing loss,
- active opioid use,
- unwillingness to participate in the study
- unwillingness to listening to music
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Teaching and Research Hospital
Ankara, Altindag
About this study
Official title: The Effect of Favorite Music on Postoperative Anxiety and Pain
In this study, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.
Read the detailed description
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) I and II.
117 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 two groups as preoperative music played and not played. The list of patients listening to the music will be played through the headphones which are the preference of the patients. The postoperative STAI questionnaire will be applied again. results will be evaluated statistically
- Conditions
- Music on Postoperative Anxiety
- Being tested
- music, no music
- Keywords
- postoperative anxiety, State - Trait Anxiety Inventory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
The preference of the patients will be listened to preoperatively through the headphones
no musicOther
the patients will not be listened
| Study group | Role | What they receive |
|---|---|---|
| music | Other | The preference of the patients will be listened to preoperatively through the headphones. Receives: Other: music |
| no music | Other | preoperative music will not be listened Receives: Other: no music |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI score
preoperative and postoperative STAI I and II score questions will be asked.
Measured: 24 hours
11-point 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start1 Feb 2019
- Primary completion1 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music on Postoperative AnxietyStudies 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
- 117 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
- NCT03816501
- Sponsor's protocol ID
- Anxiety
- Status last verified
- Sep 2019
- First submitted
- 23 Jan 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Favorite Music on Postoperative Anxiety and Pain
- ClinicalTrials.gov ID
- NCT03816501
- Acronym / sponsor ID
- Anxiety
- Conditions
- Music on Postoperative Anxiety
- Keywords
- postoperative anxiety, State - Trait Anxiety Inventory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 25 Jan 2019 (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, we are planning to evaluate whether listening to the music of the patient's choice preoperatively contributes to postoperative anxiety.
Detailed description
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) I and II.
117 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 two groups as preoperative music played and not played. The list of patients listening to the music will be played through the headphones which are the preference of the patients. The postoperative STAI questionnaire will be applied again. results will be evaluated statistically
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Other | Other: musicThe preference of the patients will be listened to preoperatively through the headphones. |
| no music | Other | Other: no musicpreoperative music will not be listened |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- inguinal hernia surgery
- speak Turkish language
Key exclusion criteria (8 listed)
- Patients with dementia and psychiatric disorders
- anxiolytic and psychiatric drug users
- patients without written consent
- poor vision,
- significant hearing loss,
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 |
|---|---|---|
| musicThe preference of the patients will be listened to preoperatively through the headphones | Other | music |
| no musicthe patients will not be listened | Other | no music |
Primary outcome
STAI score
Time frame: 24 hours
preoperative and postoperative STAI I and II score questions will be asked.
11-point numerical rating scale (NRS)
Time frame: 24 hours
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
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 25 Sep 2019.
- 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 music and no music in people with Music on Postoperative Anxiety, 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 8 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 25 Sep 2019. 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?
STAI score (time frame: 24 hours). The study lists 2 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 25 Sep 2019.