CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
music therapy +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04485650
NCT04485650N/ACompleted

The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial

Abant Izzet Baysal University·interventional·Posted Jul 24, 2020·Updated Jul 24, 2020

In Brief

A clinical study evaluating music therapy, sedated group, and 1 other intervention for Music Therapy and 6 related conditions. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status. Methods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 24, 2020
Enrollment StartFeb 24, 2017
Primary CompletionMar 15, 2017
Study CompletionMay 30, 2017
TodayJul 2, 2026
Enrollment to primary: 21 daysPosted 5.9 years ago

Interventions

music therapyother

The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.

sedated groupother

Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30

non-sedated groupother

The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30