ThyroidNCT06953011
The Effects of Different Types of Music on Patients Undergoing Thyroid Surgery
A study testing music application in people with Thyroid, run by Dicle University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid
- What is being tested?
- music application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2024to 24 Sep 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18-65,
- Hospitalized for 24 hours after surgery,
- without cognitive impairment
- consenting to participate
Who cannot join
- Individuals under the age of 18 and over the age of 65
- Individuals with cognitive impairment
- Individuals who declined to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dicle University Hospital General Surgery Clinic
Diyarbakır, Sur, 21280
About this study
Official title: The Effect of Preferred Music on Anxiety and Comfort Levels in Thyroidectomy Surgery: A Randomized Controlled Trial (RCT)
This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients.
Read the detailed description
Objective: This study was conducted to investigate the effect of preoperative music interventions on anxiety and postoperative comfort levels in patients.
Design: A randomized controlled quasi-experimental design was used. Methods: This study was conducted in the general surgery clinic of a university hospital in Diyarbakır, Turkey. A total of 100 patients (47 in the intervention and 53 in the control group) participated in the study by randomization. Personal Information Form, hemodynamic parameters, and State-Trait Anxiety Inventory were used for data collection. The State part of the State-Trait Anxiety Inventory was re-administered to the intervention group after the music intervention. In the postoperative period, hemodynamic parameters of all patients in both groups were monitoredş and the Perianesthesia Comfort Questionnaire was administered. SPSS 25.0 software was used for data analysis.
- Conditions
- Thyroid
- Being tested
- music application
- Keywords
- Anxiety, Thyroidectomy, Music, Patient comfort
- Medical subject headings
- Thyroid Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music applicationOther
Patients were met within 1 hour preoperatively. Vital signs, pain score, blood glucose were checked and state anxiety scale was applied. Music was played through headphones and speakers for at least 20 minutes according to the type of music preferred by the patients and the preferred way of listening to music, and the state anxiety scale was applied again. Patients' questions were answered and they were encouraged to share any concerns. Patients were prepared for surgery and transferred to the operating room. Considering the patient's recovery from anesthesia, patients were visited again the day after surgery, vital signs, pain score, blood glucose were checked and the perianesthesia comfort questionnaire (PCQ) was applied.
| Study group | Role | What they receive |
|---|---|---|
| music group | Experimental | Patients were met within 1 hour preoperatively. Vital signs, pain scores, and blood glucose levels were checked, and the state anxiety scale was administered. Music was played through headphones and speakers for at least 20 minutes, according to the patient's preference for both type and metod of listening. The state anxiety scale was then applied again. Patients' questions were answered and they were encouraged to share any concerns. Patient's questions were answered, and they were encouraged to share any concerns. They were prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked and the perianesthesia comfort questionnaire (PCQ) was administered. Receives: Other: music application |
| control group | No intervention | Patients were met within 1 hour preoperatively. Vital signs, pain score, and blood glucose were checked, and state anxiety scale was administered. Patients' questions were answered, and they were encouraged to share any concerns. They were then prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked, and the perianesthesia comfort questionnaire (PCQ) was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Scale
This scale is grounded in the two-factor theory of anxiety and comprises two sections with a total of 40 items. The items include both direct statements, which reflect negative emotional states, and reverse statements, which reflect positive emotional states. The total score ranges from 20 to 80, with higher scores indicating greater levels of anxiety. The first section (Items 1-20) assesses state anxiety, evaluating how the individual feels at a given moment. Respondents are asked to select one of the following options: Not at all, A little, A lot, or Completely. The second section (Items 21-40) measures trait anxiety, reflecting how the individual generally feels over time. For each item, respondents choose from: Almost never, Sometimes, Very often, or Almost always. The scale is intended to measure anxiety experienced over the past six months.
Measured: six months
Secondary outcomes (1)
Perianesthesia Comfort Questionnaire (PCQ)
This scale comprises 24 items designed to assess patients' general thoughts, self-perceptions, and emotional states before and after surgical procedures. The items are formatted using a 6-point Likert scale, with response options ranging from 1 (Strongly Disagree) to 6 (Strongly Agree). A total of 12 items are positively worded (Items 1, 5, 6, 11, 14, 16, 18, 19, 20, 21, 23, and 24), while the remaining 12 items are negatively worded (Items 2, 3, 4, 7, 8, 9, 10, 12, 13, 15, 17, and 22). Negatively worded items are reverse-coded during the scoring process.For positively worded items, higher scores indicate greater comfort, whereas lower scores reflect decreased comfort. The total scale score ranges from 24 to 144. Scoring involves summing the reverse-coded negative items and the original scores of positive items. A higher total score reflects a higher level of perceived comfort, while a lower score indicates reduced comfort.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start23 Mar 2024
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies 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
- Model description
- Two groups with a conventional therapy control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiçek SARUHAN, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953011
- Sponsor's protocol ID
- DicleU-ASBF-NURSE-ÇS-01
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preferred Music on Anxiety and Comfort Levels in Thyroidectomy Surgery: A Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT06953011
- Acronym / sponsor ID
- DicleU-ASBF-NURSE-ÇS-01
- Conditions
- Thyroid
- Keywords
- Anxiety, Thyroidectomy, Music, Patient comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 1 May 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.
This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients.
Detailed description
Objective: This study was conducted to investigate the effect of preoperative music interventions on anxiety and postoperative comfort levels in patients.
Design: A randomized controlled quasi-experimental design was used. Methods: This study was conducted in the general surgery clinic of a university hospital in Diyarbakır, Turkey. A total of 100 patients (47 in the intervention and 53 in the control group) participated in the study by randomization. Personal Information Form, hemodynamic parameters, and State-Trait Anxiety Inventory were used for data collection. The State part of the State-Trait Anxiety Inventory was re-administered to the intervention group after the music intervention. In the postoperative period, hemodynamic parameters of all patients in both groups were monitoredş and the Perianesthesia Comfort Questionnaire was administered. SPSS 25.0 software was used for data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Other: music applicationPatients were met within 1 hour preoperatively. Vital signs, pain scores, and blood glucose levels were checked, and the state anxiety scale was administered. Music was played through headphones and speakers for at least 20 minutes, according to the patient's preference for both type and metod of listening. The state anxiety scale was then applied again. Patients' questions were answered and they were encouraged to share any concerns. Patient's questions were answered, and they were encouraged to share any concerns. They were prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked and the perianesthesia comfort questionnaire (PCQ) was administered. |
| control group | No intervention | –Patients were met within 1 hour preoperatively. Vital signs, pain score, and blood glucose were checked, and state anxiety scale was administered. Patients' questions were answered, and they were encouraged to share any concerns. They were then prepared for surgery and transferred to the operating room. On the day after surgery, patients were visited again. Vital signs, pain scores, and blood glucose levels were checked, and the perianesthesia comfort questionnaire (PCQ) was administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages of 18-65,
- Hospitalized for 24 hours after surgery,
- without cognitive impairment
- consenting to participate
Key exclusion criteria (3 listed)
- Individuals under the age of 18 and over the age of 65
- Individuals with cognitive impairment
- Individuals who declined to participate in the study
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 applicationPatients were met within 1 hour preoperatively. Vital signs, pain score, blood glucose were checked and state anxiety scale was applied. Music was played through headphones and speakers for at least 20 minutes according to the type of music preferred by the patients and the preferred way of listening to music, and the state anxiety scale was applied again. Patients' questions were answered and they were encouraged to share any concerns. Patients were prepared for surgery and transferred to the operating room. Considering the patient's recovery from anesthesia, patients were visited again the day after surgery, vital signs, pain score, blood glucose were checked and the perianesthesia comfort questionnaire (PCQ) was applied. | Other | music group |
Primary outcome
State-Trait Anxiety Scale
Time frame: six months
This scale is grounded in the two-factor theory of anxiety and comprises two sections with a total of 40 items. The items include both direct statements, which reflect negative emotional states, and reverse statements, which reflect positive emotional states. The total score ranges from 20 to 80, with higher scores indicating greater levels of anxiety. The first section (Items 1-20) assesses state anxiety, evaluating how the individual feels at a given moment. Respondents are asked to select one of the following options: Not at all, A little, A lot, or Completely. The second section (Items 21-40) measures trait anxiety, reflecting how the individual generally feels over time. For each item, respondents choose from: Almost never, Sometimes, Very often, or Almost always. The scale is intended to measure anxiety experienced over the past six months.
1 secondary outcome
Perianesthesia Comfort Questionnaire (PCQ)
Time frame: six months
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 1 May 2025.
- 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 application in people with Thyroid, run by Dicle 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 3 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 1 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?
State-Trait Anxiety Scale (time frame: six months). 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 1 May 2025.