NCT06776809

Brief Summary

This randomized controlled intervention study aims to investigate the impact of music played during toe amputation on patients' anxiety, pain, sense of safety, and fear of surgery. The study will be carried out with two groups: The control and the intervention groups with 60 participants for each group. While the control group participants will receive standard care, the intervention group participants will listen to selection of Sufi music during the whole amputation procedure in addition to standard care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

February 12, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

January 10, 2025

Last Update Submit

February 9, 2025

Conditions

Amputation

Keywords

AmputationToe amputationMusicPainAnxietySurgical fearSense of Safety

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 days

  • 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.

    3 days

Secondary Outcomes (2)

  • Surgical Fear Questionnaire

    3 days

  • Safety Feeling Scale

    3 days

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 during toe amputation 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 throughout the operation. Disposable headphone covers will be used for the headphones and the covers will be changed for each patient.

Other: Music listening

Interventions

Music listeningOTHER

Selection of Sufi music will be played to the patients during the course of the operation.

Intervention Group- Listening to Sufi Music

Eligibility Criteria

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

You may qualify if:

  • years of age or above,
  • Having a toe amputation under spinal anesthesia due to diabetic foot,
  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University Hospital,

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Yeliz CIGERCI, Assoc.Prof.

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeliz CIGERCI, Assoc. Prof.

CONTACT

+902724440304Yelizceylin@hotmail.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
Assoc.Prof.

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

February 12, 2025

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

TU(1)