Preoperative AnxietyNCT05307315
The Effect of Listening to Music Before Surgery on the Anxiety of Individuals Scheduled for Urological Surgery
A study testing listening to music in people with Preoperative Anxiety, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Many patients before the operation feel a high level of anxiety. This felt anxiety can develop due to many reasons such as anesthesia, not being able to wake up from the surgery and being disabled, and fear of feeling pain after the surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- listening to music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 1 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be literate
- Being undergoing urological surgery for the first time
- Be over 18 years old
- Having agreed to participate in the study
Who cannot join
- To be hard of hearing
- Inability to communicate verbally
- Having a disease that prevents data collection
- Having difficulty wearing headphones
Trial locations and contacts
1 site in 1 country.
About this study
Many patients before the operation feel a high level of anxiety. This felt anxiety can develop due to many reasons such as anesthesia, not being able to wake up from the surgery and being disabled, and fear of feeling pain after the surgery. Music applications, which are among non-pharmacological techniques, are frequently used in the management of pain and anxiety.In this study, the effect of listening to music in the preoperative period on the anxiety of urology patients will be investigated
Read the detailed description
The anxiety felt at a high level in many patients in the pre-operative period can be caused by many reasons such as general anesthesia, anxiety about not being able to wake up from the operation, fear of being disabled, fear of pain after the operation, fear of losing control over the body, fear of sexual loss and worries about not being able to work after the operation can develop. Anxiety experienced at a high level in the preoperative period; While it causes physical problems such as dizziness, nausea and headache, it also affects the anxiety to be experienced after the surgery. Looking at the effects of preoperative anxiety in the postoperative period, it increases the intensity of postoperative pain and analgesia requirement, affects anesthesia requirements, and increases hospitalization time in some types of surgery, and as a result, increases postoperative morbidity and mortality. Anxiety levels of patients; may be affected by a wide variety of factors such as previous experiences, the way they came to the hospital, their gender, age, and the type of surgery they will undergo. In contrast, effective control of preoperative anxiety provides better management of postoperative pain and faster recovery.
The positive and curative effect of music has been the subject of constant interest from past to present and it has been used more and more among non-pharmacological techniques. Listening to music, intensive care, surgery, psychiatry, obstetrics, pediatrics, oncology services, in the process of radiotherapy and chemotherapy in patients with other diagnostic and treatment from the symptoms that arise in the process, especially in the management of pain and anxiety is often applied. In addition, it has been determined that it has important positive effects on the activation of the immune system, increasing the quality of life, reducing the amount of drugs used in the treatment of pain, shortening the hospital stay and spirituality.
In many studies in the literature examining the effect of music on anxiety associated with surgical intervention; it has been found that music reduces the level of anxiety. However, a study has also found that music does not affect the anxiety experienced by an individual. Although there are no studies evaluating the effect of music on the anxiety level of individuals scheduled for urological surgery, in a meta-analysis study evaluating the effect of music on individuals undergoing urological procedures in outpatients, it was found that music reduces anxiety.
In the nursing profession, which focuses on providing holistic care in the biopsychosocial sense, it is important to increase the quality of care by addressing the emotional experiences of the individual during physical health problems.Addressing anxiety as an emotional experience before surgical intervention within the scope of nursing interventions may contribute to increasing the quality of life of the individual.In the light of this information, this study aims to evaluate the effect of listening to music before surgery on the anxiety level of individuals who are planned for urological surgery as an independent therapeutic nursing intervention and to improve nursing care with the findings obtained from the study.
- Conditions
- Preoperative Anxiety
- Being tested
- listening to music
- Keywords
- preoperative anxiety, surgery anxiety, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listening to musicOther
Also called music
The experimental group will listen to Turkish instrumental music with headphones for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| music | Experimental | The state/trait anxiety inventory and surgery-specific anxiety inventory will be administered to the experimental group before the surgery. Then they will listen to Turkish Classical Music for 30 minutes.
The scales will be applied again 15 minutes after the music ends. Receives: Other: listening to music |
| control | No intervention | The state/trait anxiety inventory and surgery-specific anxiety scale will be administered to the control group before surgery. The same scales will be applied again 45 minutes after the scales are applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory
The preoperative anxiety levels of the experimental group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
Measured: within 5 hours before surgery
Measuring the preoperative anxiety level of the control group with the State-Trait Anxiety Inventory
The preoperative anxiety levels of the control group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate high levels of anxiety.
Measured: within 5 hours before surgery
Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory after listening to music for 30 minutes
After listening to music for 30 minutes in the experimental group, their preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
Measured: 15 minutes after listening to music
Measuring the preoperative anxiety level of the control group without listening to music with the State-Trait Anxiety Inventory
Preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory, 45 minutes after the first scales are applied, without listening to music in the control group. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
Measured: 45 minutes after the first scales are applied
Secondary outcomes (4)
Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale
The preoperative anxiety levels of the experimental group will be measured with the Surgery-Specific Anxiety Scale. The maximum score from the scale is 50. High scores indicate a high level of anxiety.
Measured: within 5 hours before surgery
Measuring the preoperative anxiety level of the control group with the Surgery-Specific Anxiety Scale
The preoperative anxiety levels of the control group will be measured with the Surgery-Specific Anxiety Scale. The maximum score that can be obtained from the scale is 50. High scores indicate high levels of anxiety.
Measured: within 5 hours before surgery
Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale after listening to music for 30 minutesmusic
After listening to music for 30 minutes in the experimental group, their preoperative anxiety levels will be measured with the Surgery-Specific Anxiety Scale. The maximum score from the scale is 50. High scores indicate a high level of anxiety.
Measured: 15 minutes after listening to music
Measuring the preoperative anxiety level of the control group without listening to music with the Surgery-Specific Anxiety Scale
Preoperative anxiety levels will be measured with the Surgery-Specific Anxiety Scale, 45 minutes after the first scales are applied, without listening to music in the control group. The maximum score from the scale is 50. High scores indicate a high level of anxiety.
Measured: 45 minutes after the first scales are applied
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 Sep 2021
- Primary completion14 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sibel Arguvanlı Çoban, Study director, Bülent Ecevit ÜniversityNeslihan Aker, Principal investigator, Bülent Ecevit Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307315
- Sponsor's protocol ID
- ZBU-SBE-NESLİHAN-AKER-0000-85
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music Before Surgery on the Anxiety of Individuals Scheduled for Urological Surgery
- ClinicalTrials.gov ID
- NCT05307315
- Acronym / sponsor ID
- ZBU-SBE-NESLİHAN-AKER-0000-85
- Conditions
- Preoperative Anxiety
- Keywords
- preoperative anxiety, surgery anxiety, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 1 Apr 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.
Many patients before the operation feel a high level of anxiety. This felt anxiety can develop due to many reasons such as anesthesia, not being able to wake up from the surgery and being disabled, and fear of feeling pain after the surgery. Music applications, which are among non-pharmacological techniques, are frequently used in the management of pain and anxiety.In this study, the effect of listening to music in the preoperative period on the anxiety of urology patients will be investigated
Detailed description
The anxiety felt at a high level in many patients in the pre-operative period can be caused by many reasons such as general anesthesia, anxiety about not being able to wake up from the operation, fear of being disabled, fear of pain after the operation, fear of losing control over the body, fear of sexual loss and worries about not being able to work after the operation can develop. Anxiety experienced at a high level in the preoperative period; While it causes physical problems such as dizziness, nausea and headache, it also affects the anxiety to be experienced after the surgery. Looking at the effects of preoperative anxiety in the postoperative period, it increases the intensity of postoperative pain and analgesia requirement, affects anesthesia requirements, and increases hospitalization time in some types of surgery, and as a result, increases postoperative morbidity and mortality. Anxiety levels of patients; may be affected by a wide variety of factors such as previous experiences, the way they came to the hospital, their gender, age, and the type of surgery they will undergo. In contrast, effective control of preoperative anxiety provides better management of postoperative pain and faster recovery.
The positive and curative effect of music has been the subject of constant interest from past to present and it has been used more and more among non-pharmacological techniques. Listening to music, intensive care, surgery, psychiatry, obstetrics, pediatrics, oncology services, in the process of radiotherapy and chemotherapy in patients with other diagnostic and treatment from the symptoms that arise in the process, especially in the management of pain and anxiety is often applied. In addition, it has been determined that it has important positive effects on the activation of the immune system, increasing the quality of life, reducing the amount of drugs used in the treatment of pain, shortening the hospital stay and spirituality.
In many studies in the literature examining the effect of music on anxiety associated with surgical intervention; it has been found that music reduces the level of anxiety. However, a study has also found that music does not affect the anxiety experienced by an individual. Although there are no studies evaluating the effect of music on the anxiety level of individuals scheduled for urological surgery, in a meta-analysis study evaluating the effect of music on individuals undergoing urological procedures in outpatients, it was found that music reduces anxiety.
In the nursing profession, which focuses on providing holistic care in the biopsychosocial sense, it is important to increase the quality of care by addressing the emotional experiences of the individual during physical health problems.Addressing anxiety as an emotional experience before surgical intervention within the scope of nursing interventions may contribute to increasing the quality of life of the individual.In the light of this information, this study aims to evaluate the effect of listening to music before surgery on the anxiety level of individuals who are planned for urological surgery as an independent therapeutic nursing intervention and to improve nursing care with the findings obtained from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music | Experimental | Other: listening to musicThe state/trait anxiety inventory and surgery-specific anxiety inventory will be administered to the experimental group before the surgery. Then they will listen to Turkish Classical Music for 30 minutes. The scales will be applied again 15 minutes after the music ends. |
| control | No intervention | –The state/trait anxiety inventory and surgery-specific anxiety scale will be administered to the control group before surgery. The same scales will be applied again 45 minutes after the scales are applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be literate
- Being undergoing urological surgery for the first time
- Be over 18 years old
- Having agreed to participate in the study
Key exclusion criteria (4 listed)
- To be hard of hearing
- Inability to communicate verbally
- Having a disease that prevents data collection
- Having difficulty wearing headphones
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 |
|---|---|---|
| listening to musicAlso: musicThe experimental group will listen to Turkish instrumental music with headphones for 30 minutes. | Other | music |
Primary outcome
Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory
Time frame: within 5 hours before surgery
The preoperative anxiety levels of the experimental group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
Measuring the preoperative anxiety level of the control group with the State-Trait Anxiety Inventory
Time frame: within 5 hours before surgery
The preoperative anxiety levels of the control group will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate high levels of anxiety.
Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory after listening to music for 30 minutes
Time frame: 15 minutes after listening to music
After listening to music for 30 minutes in the experimental group, their preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
Measuring the preoperative anxiety level of the control group without listening to music with the State-Trait Anxiety Inventory
Time frame: 45 minutes after the first scales are applied
Preoperative anxiety levels will be measured with the State-Trait Anxiety Inventory, 45 minutes after the first scales are applied, without listening to music in the control group. Scores from the scale range from 20 to 80. High scores indicate a high level of anxiety.
4 secondary outcomes
Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale
Time frame: within 5 hours before surgery
Measuring the preoperative anxiety level of the control group with the Surgery-Specific Anxiety Scale
Time frame: within 5 hours before surgery
Measuring the preoperative anxiety level of the experimental group with the Surgery-Specific Anxiety Scale after listening to music for 30 minutesmusic
Time frame: 15 minutes after listening to music
Measuring the preoperative anxiety level of the control group without listening to music with the Surgery-Specific Anxiety Scale
Time frame: 45 minutes after the first scales are applied
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 2 Dec 2022.
- Individual participant dataSharing planned: No. individual participant data will not be shared
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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.
Sibel Arguvanlı Çoban study director
Bülent Ecevit Üniversity
Neslihan Aker principal investigator
Bülent Ecevit Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing listening to music in people with Preoperative Anxiety, run by Zonguldak Bulent Ecevit 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 4 inclusion and 4 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 2 Dec 2022. 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?
Measuring the preoperative anxiety level of the experimental group with the State-Trait Anxiety Inventory (time frame: within 5 hours before surgery). The study lists 4 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 2 Dec 2022.