NCT04699084

Brief Summary

To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

1.9 years

First QC Date

January 5, 2021

Last Update Submit

January 12, 2021

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Postoperative Pain was measured with the Visual Analogue Scale (VAS). This is a straight horizontal line of fixed length, usually 100 mm. The ends of the line are defined as the extreme limits of the measured parameter (pain). Specifically, the left end signifies the complete absence of pain and the right end represents the worst possible pain. Patients were asked to rate their pain by indicating a point on the straight line. Higher VAS scores mean more pain intensity. The more is the reduction of VAS score from the baseline measurement, the better is the outcome.

    Change of VAS was evaluated; from the beginning (time of arrival at the PACU, baseline), to the middle (10 minutes after surgery), to the end of the music intervention (20 minutes after surgery) at the PACU and to 2 hours after surgery in the ward.

Secondary Outcomes (4)

  • Systolic and diastolic blood pressure

    Change of blood pressure was evaluated during the first postoperative day.

  • Heart rate

    Change of heart rate was evaluated during the first postoperative day.

  • Respiratory rate

    Change of respiratory rate was evaluated during the first postoperative day.

  • Oxygen saturation

    Change of oxygen saturation was evaluated during the first postoperative day.

Study Arms (2)

Music Group

EXPERIMENTAL

Patients received music intervention and usual postoperative care.

Other: Mozart music

Control Group

NO INTERVENTION

Patients received only postoperative usual care.

Interventions

Mozart musicOTHER

A 20-minute piece composed by W.A Mozart ( Sonata K. 448 in D Major for 2 pianos) was applied in music group, directly after the arrival of patients in the Post Anesthesia Care Unit (PACU), while they were receiving usual postoperative care.

Music Group

Eligibility Criteria

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

You may qualify if:

  • Adults scheduled for total thyroidectomy under general anesthesia

You may not qualify if:

  • Visual impairments
  • Hearing impairments
  • Severe anxiety or other psychiatric disorders
  • History of chronic pain
  • Past complications during anesthesia or surgery
  • American Society of Anesthesiologists (ASA) physical status beyond II

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hygeia Hospital

Athens, 15123, Greece

Location

Related Publications (1)

  • Tripyla N, Katsas K, Karagkouni K, Liosis I, Ntelis S, Linos D. Evaluation of the effect of Mozart music on pain and respiratory rate after thyroidectomy. Hormones (Athens). 2023 Mar;22(1):113-119. doi: 10.1007/s42000-022-00421-7. Epub 2022 Nov 22.

    PMID: 36418659DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Dimitrios Linos, MD, Ph.D.

    Hygeia Hospital, National and Kapodistrian University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to two groups. One group underwent a music intervention postoperatively, while the other received only usual postoperative care (control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

February 20, 2018

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)