NCT04806204

Brief Summary

Aim: This study was planned as randomized controlled to determine the effect of music therapy applied before and during angiography on pain, anxiety and physiological parameters after angiography. The study was planned as a pre-test, post-test design, single center, randomized controlled experimental study.The study is planned to be conducted in the coronary angiography (CAG) unit of a university hospital between January 2021 and December 2021., the study sample will be composed of a total of 102 individuals, 34 in each group (intervention 1 group listening to music before the procedure = 34, intervention 2 group listening to music during the procedure = 34, control group = 34).Data in the research; The Introductory Form will be collected using the State-Trait Anxiety Scale, Vital Signs Follow-up Form and Visual Pain Scale (VAS).Patients in the Intervention 1 group will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedure.Patients in the Intervention 2 group will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played through a speaker that will be placed in the angiography hall during the CAG procedure. Routine care will be applied to patients in this group and music therapy will not be applied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 27, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

January 27, 2021

Last Update Submit

September 29, 2021

Conditions

Nursing CariesComplementary TherapiesCardiology

Keywords

Coronary AngiographyMusic TherapyVital SignsAnxiety

Outcome Measures

Primary Outcomes (8)

  • Means of subjective anxiety scores

    State-Trait Anxiety Scale is used to measure subjective anxiety. The original of this scale was developed by Spielberger et al. In 1970 to determine the level of anxiety. It consists of two parts as "State and Trait Anxiety Scale". State Anxiety Scale is a 4-point Likert type scale consisting of 20 questions aiming to measure how individuals feel at the moment. The scores obtained from the scale vary between 20 and 80, and a high score indicates that anxiety is high, and a low score indicates that anxiety level is low. The 20-item trait anxiety inventory shows the general feelings of the person under the situation and conditions.Scores from each scale range between 20 and 80. A high score means high, and a low score means a low level of anxiety.

    up to 20 minutes post-angiography

  • Means of subjective pain scores

    The visual pain scale will be used to assess the patient's subjective pain. The patient will be asked to score his pain on the scale from 0 to 10. Average pain scores will be calculated for pain assessment.

    up to 15 minutes post-angiography

  • Means of body temperature (0C)

    It will be measured by the clinical nurse using an infrared thermometer.

    up to 15 minutes post-angiography

  • Means of systolic blood pressure (mmHg)

    The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by the clinical nurse.

    up to 15 minutes post-angiography

  • Means of diastolic blood pressure (mmHg)

    The measurement on the arm, which is not operated with a digital blood pressure meter, will be made by the clinical nurse.

    up to 15 minutes post-angiography

  • Means of heart rate (/minutes)

    It will be measured by the clinical nurse with a pulse oximeter in the unprocessed arm.

    up to 15 minutes post-angiography

  • Means of respiratory rate (/minutes)

    It will be counted by the clinical nurse by monitoring chest movements for one minute.

    up to 15 minutes post-angiography

  • Means of oxygen saturation (%)

    It will be measured by the clinical nurse with a pulse oximeter in the unprocessed arm.

    up to 15 minutes post-angiography

Study Arms (3)

music therapy before the angiography

EXPERIMENTAL

Patients in the Intervention 1 group will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played with headphones for 15-20 minutes before the CAG procedure. Since individuals are in the CAG unit collectively before the procedure, headphones will be used in order not to disturb other individuals. After the interviews, musical types will be arranged as instrumental, non-verbal, at 70 decibels, approximately 60 metronome per minute, in terms of rhythm and duration, and will be played according to the individual's choice. Instrumental works will be uploaded to the portable MP3 player provided by the researchers.

Other: music therapy

music therapy during the angiography

EXPERIMENTAL

Patients in the Intervention 2 group will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played through a speaker that will be placed in the CAG hall during the CAG procedure. After the interviews, musical types will be arranged as instrumental, non-verbal, 75 decibels, approximately 60 metronome per minute, in terms of rhythm and duration, and will be played according to the individual's choice.

Other: music therapy

control group

NO INTERVENTION

After the polyclinic controls of the patients, on the day of the CAG procedure, data collection forms will be applied in the CAG unit 30 minutes before the procedure. Routine care will be applied to patients in this group and music therapy will not be applied. The physiological parameters of the patient will be measured by the clinical nurse 15 minutes after the procedure, and data collection forms will be applied again 20 minutes later.

Interventions

music therapyOTHER

Music therapy will be applied to one group before angiography and to the other group during angiography. Patients who will listen to music before angiography will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played with headphones for 15-20 minutes. Patients who will listen to music during angiography will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played through a speaker that will be placed in the angiography hall during the angiography procedure.

music therapy before the angiographymusic therapy during the angiography

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Can speak and understand Turkish
  • No hearing problems
  • Oriented to place and time
  • Have no psychiatric illness
  • Sedative or analgesic medication within the last 24 hours
  • where the intervention will be made in the ral zone
  • The first time angiography procedure will be applied
  • Individuals who are volunteers will be included in the study.

You may not qualify if:

  • Under the age of 18
  • Do not speak Turkish
  • Have a hearing problem
  • Without a place and time orientation
  • Have any psychiatric illness
  • Using sedative or analgesic drugs in the last 24 hours
  • To be intervened outside the femoral area
  • Previous angiography procedure
  • Non-volunteer individuals will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University Izzet Baysal Training and Research Hospital

Bolu, Center, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Saadet Can Cicek, Dr.

    Bolu Abant Izzet Baysal University, Health Sciences Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2021

First Posted

March 19, 2021

Study Start

January 27, 2021

Primary Completion

December 27, 2021

Study Completion

December 27, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

TU(1)