- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953011
The Effects of Different Types of Music on Patients Undergoing Thyroid Surgery
The Effect of Preferred Music on Anxiety and Comfort Levels in Thyroidectomy Surgery: A Randomized Controlled Trial (RCT)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Sur
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Diyarbakir, Sur, Turkey, 21280
- Dicle University Hospital General Surgery Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages of 18-65,
- Hospitalized for 24 hours after surgery,
- without cognitive impairment
- consenting to participate
Exclusion Criteria:
- Individuals under the age of 18 and over the age of 65
- Individuals with cognitive impairment
- Individuals who declined to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music group
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.
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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.
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No Intervention: control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perianesthesia Comfort Questionnaire (PCQ)
Time Frame: six months
|
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.
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six months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DicleU-ASBF-NURSE-ÇS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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