NCT06074991

Brief Summary

This study will be conducted to determine the effect of music therapy on pain and anxiety following coronary angiography in patients in intensive care. 60 patients who underwent coronary angiography will be randomized and divided into experimental (n = 30) and control (n = 30) groups. "Personal Data Form", "Pain Visual Analog Scale (Pain-VAS)", "Anxiety Visual Analog Scale (Anxiety-VAS)" and "Richmond Agitation and Sedation Scale (RASS)" were used to collect data. While participants in the experimental group will be given a problem-solving training program, no intervention will be made to the control group. The data in the control and experimental groups will be distributed homogeneously.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable 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

April 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

April 5, 2023

Last Update Submit

October 6, 2023

Conditions

Keywords

PainAnxiety

Outcome Measures

Primary Outcomes (2)

  • Pain Visual Analog Scale

    Pain-VAS, the validity and reliability of which was tested by Price, McGrath, Rafii, and Buckingham, is a measurement tool that measures both pain intensity and pain relief, which is easy, effective, repetitive and requires minimal tools. It is a one-dimensional scale whose validity and reliability studies have been conducted in Turkey and which is used to measure subjective components of pain intensity. VAS is 10 cm long drawn horizontally or vertically. It is a ruler that starts with 0cm "No pain" and ends with 10cm "Unbearable pain".Change from Pain-VAS at 60 minutes.

    0,30,60 minutes

  • Anxiety Visual Analog Scale

    Although the beginning of the use of the visual analog scale dates back to the early 20th century, its worldwide use became widespread in 1969 with the research of Zealley and Aitken. The VAS typically consists of a 10-centimeter double-ended line. At either end of this line are words describing the two extremes of the emotion to be measured (for example, Zero-Maximum). Patients are asked to mark where their current feeling is anywhere on the scale, and the distance from the minimum (zero) end gives the patient's score.Change from Anxiety-VAS at 60 minutes.

    0,30,60 minutes

Secondary Outcomes (1)

  • Richmond Agitation and Sedation Scale

    0,30,60 minutes

Study Arms (2)

experimental group

EXPERIMENTAL

Music therapy was applied to the patients in the experimental group with the help of mp3 and headphones for 30 minutes in a position where they felt comfortable. Hüseyni makam was used for music therapy. Posttest-1 data were collected immediately after the end of the music therapy. 30 minutes after the posttest-1 data, the posttest-2 data were collected. The patients in the control group, on the other hand, did not undergo any procedure other than medical intervention. Posttest-1 data were collected 30 minutes after the pretest and posttest-2 data 30 minutes after the posttest-1.

Other: musıc therapy

control group

NO INTERVENTION

The control group did not receive any therapy, and there was no interaction between the experimental group and the control group during the training period.

Interventions

Music therapy was applied to the patients in the experimental group with the help of mp3 and headphones for 30 minutes in a position where they felt comfortable. Hüseyni makam was used for music therapy.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Accepting to participate in the study voluntarily,
  • Being open to communication,
  • be over 18 years old,
  • Application of coronary angiography for the first time,
  • Having a score of 0 or higher according to the Ramsay Sedation Scale,
  • Being on the first day of intensive care treatment,
  • This is the first time he is being treated in the intensive care unit.

You may not qualify if:

  • By-pass decision after coronary angiography,
  • Transferring the patient to the ward after coronary angiography,
  • Having additional psychiatric disorders,
  • Being hospitalized in intensive care before,
  • It is the presence of delirium in the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

April 5, 2023

First Posted

October 10, 2023

Study Start

April 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 3, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations