NCT06756919

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

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

June 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

December 24, 2024

Last Update Submit

December 24, 2024

Conditions

Music Therapy

Keywords

musicendoscopynursingpainvital signs

Outcome Measures

Primary Outcomes (3)

  • State-trait anxiety inventory

    6 months

  • Visual Analog Scale

    6 months

  • Patient Information Form

    6 months

Study Arms (2)

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

Music interventionBEHAVIORAL

Music therapy ( nature sounds) during the endoscopy procedure

Patients Having Endoscopy with Music Therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind Trial
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 3, 2025

Study Start

June 15, 2023

Primary Completion

December 31, 2023

Study Completion

November 1, 2024

Last Updated

January 3, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)