Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06074991 |
Other study ID # |
2023 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.