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The Effect of Music Therapy on Pain Level and Analgesic Consumption

Primary Purpose

Orthopedic Surgery, Pain, Postoperative, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music Therapy Mobile Application
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Orthopedic Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Accepting to participate in the study, being over the age of 18, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being able to read and write

Exclusion Criteria:

Being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.

Sites / Locations

  • Cukurova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music group

control group

Arm Description

the group using the music therapy mobile application

the group that received routine care and treatment

Outcomes

Primary Outcome Measures

The Numerical Rating Scale (NRS)
It starts with the absence of pain (0) on numerical scales and reaches the level of unbearable pain (10-100). Numerical scales are used by patients to facilitate the definition of pain intensity, to facilitate scoring and recording, and to evaluate ceiling and floor effects.

Secondary Outcome Measures

Analgesic consumption amount
The amount of analgesic used by the patients after the surgery will be recorded in the table.

Full Information

First Posted
June 15, 2022
Last Updated
June 12, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05424211
Brief Title
The Effect of Music Therapy on Pain Level and Analgesic Consumption
Official Title
The Effect of Music Therapy on Pain Level and Analgesic Consumption of Patients After Orthopedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pain is a common condition experienced by patients in long-term health care, rehabilitation and acute situations, due to various surgical interventions and invasive procedures, and postoperative pain is an important symptom experienced by patients during the surgical recovery process. The International Association for the Study of Pain (IASP) defines pain as an unpleasant emotional experience associated with actual or potential tissue damage (Lok, Ibrahim and Sidani 2020; Çavdar and Akyüz 2017; Martin-Saavedra, Vergara-Mendez, Talero-Gutiérrez 2018). Orthopedic surgical interventions are considered to be one of the most painful surgical procedures, and pain control requires a multifaceted approach that includes non-pharmacological techniques (Allred et al. 2010). Music therapy, which is one of the non-traditional treatment methods, is used to reduce pain (Nilson 2008). Music can easily be included in nursing care because it is applied without the physician's request and causes very little legal and ethical concerns (Simcock et al. 2008). However, due to the lack of awareness about the effectiveness of music therapy, it is not often used as an intervention. Inadequate pain control causes a decrease in patient satisfaction and deterioration of the healing process (Lukas 2004). Therefore, this study was planned as a randomized controlled experimental study to determine the effect of music therapy on the pain level of patients undergoing orthopedic surgery.
Detailed Description
This study was planned as a randomized controlled experimental study to determine the effect of music therapy on the level of pain after orthopedic surgery. The population of the research will consist of patients who have undergone orthopedic surgery in the orthopedic service of a university hospital. In a similar study in the literature (Tolunay et al. 2018), the number of samples was calculated on the basis of 95% confidence interval, 80% power level, 0.05 error level, 0.84 effect level, considering the pain averages of the experimental and control groups. As a result of the power analysis, at least 19 patients were included in the experimental and control groups, and it was determined that a total of at least 38 patients could form the sample group; however, it was decided to complete the study with a total of 80 patients by assigning 40 patients to each group so that parametric tests could be performed during the data analysis. Inclusion criteria for the study: Accepting to participate in the study, being over 18 years old, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being literate. Exclusion criteria for the study: being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy. Data will be collected by Patient Information Form, Numerical Scale (NRS) and Short Form. Implementation of Research: First stage: All patients who meet the sampling criteria will be informed about the type, purpose and application process of the pre-intervention study, and written and verbal consent will be obtained for participation. In order to prevent individuals from being informed about the interventions, the participants will be randomized to the experimental and control groups according to the period of admission to the hospital. According to the results of randomization, patients will be assigned to the group (experimental group) and the control group. Researchers will maintain the confidentiality of patients' identity and study-related information using serial numbers. Second stage: After the explanations about the study are made and the necessary written and verbal consent is obtained, a structured information form containing information about socio-demographic variables such as age, gender, education, alcohol and smoking use, chronic disease of all participants will be filled. Third stage: Music Therapy Mobile Application: The authorities determined by consulting TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon. Each patient will be given a personal headphone probe to listen to music. Pain assessment will be done with NRS before and immediately after the application. Routine treatment and care of the patients in the control group will continue.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Surgery, Pain, Postoperative, Analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music group
Arm Type
Experimental
Arm Description
the group using the music therapy mobile application
Arm Title
control group
Arm Type
No Intervention
Arm Description
the group that received routine care and treatment
Intervention Type
Device
Intervention Name(s)
Music Therapy Mobile Application
Intervention Description
The authorities determined by taking consultancy from TÜMATA (Turkish Music Research and Promotion Group) will be uploaded to the mobile application developed by the software specialist. The maqams (Rast, Nihavent and Neva) to be used in the application will be played to the patients 3 times in half an hour at different times of the day via the mobile application. Rast tonality will be played in the morning, nihavent tune will be played at noon and neva tune will be played in the afternoon.
Primary Outcome Measure Information:
Title
The Numerical Rating Scale (NRS)
Description
It starts with the absence of pain (0) on numerical scales and reaches the level of unbearable pain (10-100). Numerical scales are used by patients to facilitate the definition of pain intensity, to facilitate scoring and recording, and to evaluate ceiling and floor effects.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Analgesic consumption amount
Description
The amount of analgesic used by the patients after the surgery will be recorded in the table.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Accepting to participate in the study, being over the age of 18, having undergone orthopedic surgery, not having mental and auditory problems, not having chronic pain, being able to read and write Exclusion Criteria: Being younger than 18 years of age, undergoing non-elective orthopedic surgery, coming from the intensive care unit, having mental and auditory problems, chronic pain, illiteracy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Açelya Türkmen, PhD
Organizational Affiliation
Cukurova University
Official's Role
Study Chair
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Music Therapy on Pain Level and Analgesic Consumption

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