Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05424211 |
| Other study ID # |
CU-SBF-AT-03 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
June 2023 |
| Source |
Cukurova University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
