The Effects of Different Types of Music on Patients Undergoing Thyroid Surgery

NCT06953011 — Not applicable, Completed, 100 participants, Dicle University

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The Effect of Preferred Music on Anxiety and Comfort Levels in Thyroidectomy Surgery: A Randomized Controlled Trial (RCT)

RegistryNCT06953011
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment100 (Actual)
SponsorDicle University (Other)
ConditionsThyroid
Interventionsmusic application (Other)
Datesstart 2024-03-23, primary completion 2024-09-24, completion 2024-09-24, first posted 2025-05-01, last updated 2025-05-01
Locations1 site in Turkey (Türkiye)

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-Summary

This study was conducted to investigate the effect preoperative music interventions on anxiety and postoperative comfort level in patients.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
music groupExperimentalOther: 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 groupNo interventionPatients 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.
  • music application (Other): 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.

+Outcome measures

Primary outcomes

  • State-Trait Anxiety Scale [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.

Secondary outcomes

  • Perianesthesia Comfort Questionnaire (PCQ) [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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Dicle University Hospital General Surgery ClinicDiyarbakır, SurTurkey (Türkiye)