EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS (MUSCOPY)

December 24, 2024 updated by: Şerife Naz Bozkurt, Ankara Yildirim Beyazıt University

EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS: A RANDOMIZED CONTROLLED STUDY

This study was conducted to evaluate the effect of music therapy on the vital signs, anxiety and pain of the patients during endoscopy procedure

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to the effects of music during the endoscopy procedure on anxiety, pain and vital signs.This study was conducted as a randomized, controlled, double-blind trial. The study population consisted of patients in the endoscopy unit of a university hospital between June and December 2023. The patients were randomly divided into the experimental group, who listened to music during endoscopy, and the control group, which did not receive any intervention other than routine nursing care. This study, data were collected via a patient information form, the State-Trait Anxiety Inventory (STAI-State), the visual analogue scale (VAS), and a vital signs monitoring form.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06520
        • Ankara Yıldırım Beyazıt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have endoscopy procedure
  • Being older than 18 years old
  • Not having hearing problems
  • ASA status between 1-3

Exclusion Criteria:

  • Cognitive or psycological disorders
  • Regular usage of analgesic/anxiolytic/sedaditive drugs
  • Haemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Having Endoscopy with Music Therapy
Patients having endoscopy procedure with music therapy
Behavioral: Music intervention
Music therapy ( nature sounds) during the endoscopy procedure
No Intervention: Control Group
Patients having endoscopy without music therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
State-trait anxiety inventory
Time Frame: 6 months
6 months
Visual Analog Scale
Time Frame: 6 months
6 months
Patient Information Form
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023/176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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