EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIET... | NCT06756919

Studies
EFFECTS OF MUSIC THERAPY DURING ENDOSCOPY ON PAIN, ANXIETY AND VITAL SIGNS

NCT06756919

Sponsor

Ankara Yildirim Beyazıt University

Status

Completed

Last Update Posted

Jan 3, 2025Actual

Enrollment

75Actual

Phase

Not Applicable

Conditions

Music Therapy

Interventions

Music intervention

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2023Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Nov 1, 2024Actual

First Submitted Date

Dec 24, 2024

First Submission Date that Met QC Criteria

Dec 24, 2024

First Posted Date

Jan 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2024

Last Update Posted Date

Jan 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Şerife Naz Bozkurt, Principal Investigator, Ankara Yildirim Beyazıt UniversityPrincipal Investigator

Lead Sponsor

Ankara Yildirim Beyazıt UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients Having Endoscopy with Music Therapy	Experimental	Patients having endoscopy procedure with music therapy	Behavioral: Music intervention
Control Group	No Intervention	Patients having endoscopy without music therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Music intervention	Behavioral	Music therapy ( nature sounds) during the endoscopy procedure	Patients Having Endoscopy with Music Therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Yıldırım Beyazıt University		Ankara		06520	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42056970	Derived	Bozkurt SN, Kocasli S. Effects of music during endoscopy on pain, anxiety and vital signs: a randomized controlled study. BMC Complement Med Ther. 2026 Apr 29. doi: 10.1186/s12906-026-05381-8. Online ahead of print.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms