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Completed

NCT Number: NCT04277559

The Effect of Music on Postoperative Anxiety

In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dışkapı Yıldırım Beyazıt Training and Research Hospital

Ankara, Gölbaşı, 06100, Turkey (Türkiye)

About this study

Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergo inguinal hernia surgery under general anesthesia,
  • Being the ability to speak, read and write the Turkish language

Exclusion criteria

  • Poor vision
  • Significant hearing loss
  • Dementia
  • Active opioid use
  • Regular use of anxiolytics or discontinuation of them on the day of surgery
  • Unwillingness to participate in the study
  • Unwillingness to listening to music

Treatment and study plan

Patient preferential music

Other

Patients will listen to their preferred music through the headphones before surgery.

Classical music

Other

Patients will listen to classical music through headphones before surgery.

no music

Other

Patients will not listen to music.

Primary outcomes

  1. Spielberg State-Trait Anxiety Inventory (STAI) score

    Time frame: 4 hours

    The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.

Secondary outcomes

  1. Numerical Rating Scale (NRS)

    Time frame: 24 hours

    11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

  2. The quality of postoperative functional recovery (QoR-40) score

    Time frame: 24 hours

    The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.

  3. Patient satisfaction score

    Time frame: 24 hours

    Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2020
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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