AtaturkU: The Effect of Music Therapy on Pain and Anxiety

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT06074991
Collaborator
Nurse Researcher Fatih BÜDÜŞ (Other)
60
1
2
21.1
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: musıc therapy
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
The Effect of Music Therapy on Pain and Anxiety in Intensive Care Patients
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jan 1, 2023
Actual Study Completion Date :
Jan 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

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
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.

No Intervention: control group

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.

Outcome Measures

Primary Outcome Measures

  1. Pain Visual Analog Scale [0,30,60 minutes]

    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.

  2. Anxiety Visual Analog Scale [0,30,60 minutes]

    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.

Secondary Outcome Measures

  1. Richmond Agitation and Sedation Scale [0,30,60 minutes]

    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 Sılay 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Yakutiye Turkey 25040

Sponsors and Collaborators

  • Ataturk University
  • Nurse Researcher Fatih BÜDÜŞ

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kübra Gökalp, Phd, Ataturk University
ClinicalTrials.gov Identifier:
NCT06074991
Other Study ID Numbers:
  • 2023
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kübra Gökalp, Phd, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023