NCT06285383

Brief Summary

The effects of passive music listening on pain, anxiety and quality of life in patients with chronic neck pain in addition to physical therapy will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

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

February 15, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 29, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

October 17, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 22, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Beck anxiety inventory

    The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).

    baseline and 4 weeks

  • Visual Analogue Scale

    A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.

    baseline and 4 weeks

  • Short form-36

    The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. It comprises 36 questions that cover eight domains of health: Limitations in physical activities because of health problems. Limitations in social activities because of physical or emotional problems Limitations in usual role activities because of physical health problems Bodily pain General mental health (psychological distress and well-being) Limitations in usual role activities because of emotional problems Vitality (energy and fatigue) General health perceptions

    baseline and 4 weeks

Study Arms (2)

control group

OTHER

Participants in the control group will receive classical physiotherapy 5 days a week for 4 weeks (Tens 20 min, ultrasound 5 min, hotpack 20 min).

Other: classic physical therapy

Music group

EXPERIMENTAL

Participants in the music group will be played Pachabel Canon D major (30 minutes) during the classical physical therapy session, free from external sounds (max 70 dB through headphones).

Other: Music listeningOther: classic physical therapy

Interventions

Participants will listen to the music pieces Pachabel Canon in D major (30 minutes), free from external sounds (max 70 dB through headphones).

Music group

classic physical therapy

Music groupcontrol group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with neck pain for more than 3 months with pain severity of 5 or greater according to the visual analogue scale (VAS)

You may not qualify if:

  • individuals who regularly take painkillers or anti-depressant and cortisone; and individuals having severe chronic illness and spine surgery were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Savaş Torlak

Karatay, Eyalet/Yerleşke, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2024

First Posted

February 29, 2024

Study Start

February 15, 2024

Primary Completion

July 15, 2024

Study Completion

July 15, 2024

Last Updated

October 17, 2024

Record last verified: 2024-02

Locations