NCT05424211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

May 9, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

June 15, 2022

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Analgesic consumption amount

    1 year

Study Arms (2)

Music group

EXPERIMENTAL

the group using the music therapy mobile application

Device: Music Therapy Mobile Application

control group

NO INTERVENTION

the group that received routine care and treatment

Interventions

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.

Music group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Açelya Türkmen, PhD

    Cukurova University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

May 2, 2021

Primary Completion

April 1, 2022

Study Completion

June 1, 2022

Last Updated

May 9, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations