The Effect of Music Therapy on Pain and Anxiety

Pain Clinical Trial

— AtaturkU  

Official title:

The Effect of Music Therapy on Pain and Anxiety in Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06074991
• Other study ID #: 2023
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 3, 2023

Study information

• Verified date: October 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Personal Data Form The form, which was prepared by the researchers by scanning the literature, consists of questions questioning the patients' age, gender, marital status, socioeconomic status, the post-operative day, whether they had previous intensive care experience, whether they had a psychiatric diagnosis, and the Glasgow Coma Scale score.

Pain Visual Analog Scale Pain-VAS, the validity and reliability of which was tested by Price, McGrath, Rafii, and Buckingham58, 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 carried out in Turkey and which is used to measure subjective components of pain intensity. The VAS is a 10 cm long ruler drawn horizontally or vertically, starting with "No pain" and ending with "Unbearable pain".

Anxiety Visual Analog Scale Although the use of the visual analogue scale dates back to the early 20th century, its worldwide use became widespread in 1969 with the research of Zealley and Aitken.60 The VAS typically consists of a 10-centimeter closed-end 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.

Richmond Agitation and Sedation Scale RASS was developed in collaboration with a multidisciplinary team at the University of Virginia as a result of studies at Richmond Virginia Commonwealth University. 61 Turkish Validity and Reliability Study was conducted by Sılay and Akyol62. RASS is a 10-stage scoring system in which patients are evaluated by making eye contact apart from verbal stimuli. Although there are many scales used to evaluate patients in intensive care units with adult patients, the RASS has a very good rating compared to these scales. RASS scale is evaluated between -5 level and +4 level. As it decreases to -5 level, the patient's sedation increases, and as it rises to +4 level, his agitation increases. Our most ideal level is 0.

Research data will be collected by the researcher using face-to-face interview technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 3, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Seizures

Intervention

Other:
• music therapy
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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum	Yakutiye

Sponsors (2)

Lead Sponsor	Collaborator
Ataturk University	Nurse Researcher Fatih BÜDÜS

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Richmond Agitation and Sedation Scale	RASS was developed in collaboration with a multidisciplinary team at the University of Virginia as a result of studies at Richmond Virginia Commonwealth University. Turkish Validity and Reliability Study was conducted by Silay and Akyol. RASS is a 10-stage scoring system in which patients are evaluated by making eye contact apart from verbal stimuli. RASS scale is evaluated between -5 level and +4 level. As it decreases to -5 level, the patient's sedation increases, and as it rises to +4 level, his agitation increases. Our most ideal level is 0.	0,30,60 minutes