NCT06953011

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 18, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

AnxietyThyroidectomyMusicPatient comfort

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (1)

  • Perianesthesia Comfort Questionnaire (PCQ)

    six months

Study Arms (2)

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.

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.

Interventions

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.

music group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages of 18-65,
  • Hospitalized for 24 hours after surgery,
  • without cognitive impairment
  • consenting to participate

You may not qualify if:

  • Individuals under the age of 18 and over the age of 65
  • Individuals with cognitive impairment
  • Individuals who declined to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dicle University Hospital General Surgery Clinic

Diyarbakır, Sur, 21280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Thyroid DiseasesAnxiety Disorders

Condition Hierarchy (Ancestors)

Endocrine System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Randomization was performed to ensure that patients who met the inclusion criteria among those admitted to the clinic for thyroidectomy surgery had an equal chance of being selected for the study. In order to perform randomized sampling, a table of random numbers was obtained over the internet in the computer environment by specifying the number of samples. A lottery method was then used to assign patients to either the intervention or control groups. To prevent mutual influence, patients were hospitalized in separate rooms.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Two groups with a conventional therapy control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 18, 2025

First Posted

May 1, 2025

Study Start

March 23, 2024

Primary Completion

September 24, 2024

Study Completion

September 24, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations