Effect of Music During Wound Debridement

NCT06825325 | Not Yet Recruiting

• 1 other identifier: 2024/505
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled intervention study aims to investigate the effect of music played before the debridement on patients' anxiety, pain, and sense of safety. The study will be carried out with two groups: The control and the intervention groups with 100 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music before the debridement in addition to standard care.

Conditions

Debridement

Keywords

Debridement; Music; Pain; Anxiety; Sense of Safety

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale-Pain (NRS-P)

  The Numerical Rating Scale-Pain (NRS-P) is a one-dimensional tool that uses 11 numbers, ranging from 0 to 10, to assess pain intensity. The patient selects the number that most accurately reflects the severity of their pain, with 0 representing "no pain" and 10 indicating "the worst (unbearable) pain". The NRS-P is widely recognized as an effective method for measuring pain intensity, and it is generally considered more valid and reliable than other pain assessment scales.

  15 minutes before the procedure and 5 minutes after the procedure

• Numerical Rating Scale-Anxiety (NRS-A)

  The Numerical Rating Scale-Anxiety (NRS-A) has been widely used in research to assess anxiety levels, with its reliability and validity well-established. This scale, which ranges from 0 to 10, measures anxiety from "No Stress" (0) to "Very Bad Stress" (10). A higher score indicates a greater level of anxiety. The scale categorizes raw anxiety scores as follows: 0-no anxiety, 1-3-slightly anxious, 4-6-moderately anxious, 7-9-very or extremely anxious, and 10-the worst imaginable or extremely anxious.

  15 minutes before the procedure and 5 minutes after the procedure

Secondary Outcomes (1)

• Safety Feeling Scale

  15 minutes before the procedure and 5 minutes after the procedure

Study Arms (2)

Control Group

NO INTERVENTION

Patients in the control group will not be allowed to listen to music. These patients will receive standard health care in the Diabetic Foot and Wound Care Clinic.

Intervention Group- Listening to Sufi Music

EXPERIMENTAL

Patients in this group will listen to Sufi music for 15 minutes before the wound debridement in addition to standard health care in the Diabetic Foot and Wound Care Clinic. Music will be played to the patients with the help of Mp3 player and headphones. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient.

Other: Music Listening

Interventions

Music Listening OTHER

Selection of Sufi music will be played to the patients before the wound debridement.

Intervention Group- Listening to Sufi Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or above,
• Visiting the hospital due to diabetic foot,
• Requiring wound debridement,
• Having wound debridement at least once before,
• Without hearing/speech impairment,
• Without a diagnosis of psychiatric disorders,
• Without any professional training in music,
• and volunteered to participate.

You may not qualify if:

• Patients under 18 years of age,
• Visiting the hospital for other wound causes,
• Having debridement before and after toe amputation,
• Having wound debridement for the first time
• With hearing/speech impairment,
• With a diagnosis of psychiatric disorders,
• With any kind of professional training in music,
• and not willing to participate in the study.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Serpil UYAR, Asst. Prof.

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serpil UYAR, Asst. Prof.

CONTACT

+905055266016; serpilrayu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: February 26, 2025
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02