Smartphone-Based vs Face-to-Face Counseling for Tinnitus

NCT07324603 | Completed

• 2 other identifiers: İ04-201-23124S118
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of smartphone-based counseling and face-to-face counseling in adults with chronic tinnitus. Both interventions are based on the same structured counseling protocol and are delivered over a six-week period. The primary research question is whether smartphone-based counseling can achieve clinical outcomes comparable to those of traditional face-to-face counseling in reducing tinnitus-related impact and associated symptoms.

Conditions

Chronic Tinnitus

Keywords

Chronic tinnitus; Counseling; Smartphone-based counseling; Digital Health; Mobile Application; Patient Education

Outcome Measures

Primary Outcomes (1)

• Tinnitus Impact

  Change in tinnitus impact assessed using the Tinnitus Handicap Inventory (THI).

  Baseline to 6 weeks

Secondary Outcomes (4)

• Depressive Symptoms

  Baseline to 6 weeks

• Sleep Quality

  Baseline to 6 weeks

• Perceived Tinnitus Severity

  Baseline to 6 weeks

• Tinnitus-Related Annoyance

  Baseline to 6 weeks

Study Arms (2)

Face-to-Face Counseling

EXPERIMENTAL

Participants receive structured tinnitus counseling delivered in person using a standardized educational booklet over a six-week period.

Behavioral: Face-to-Face Tinnitus Counseling

Smartphone-Based Counseling

EXPERIMENTAL

Participants receive the same structured tinnitus counseling delivered via a mobile application with sequential modules over a six-week period.

Behavioral: Smartphone-Based Tinnitus Counseling

Interventions

Face-to-Face Tinnitus Counseling BEHAVIORAL

Structured tinnitus counseling is delivered in person using a standardized educational booklet over a six-week period.

Face-to-Face Counseling

Smartphone-Based Tinnitus Counseling BEHAVIORAL

Structured tinnitus counseling is delivered via a mobile application with sequential modules over a six-week period

Smartphone-Based Counseling

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of chronic subjective tinnitus lasting at least 6 months
• Completion of a comprehensive audiological evaluation
• Ability to read and understand the study materials
• Adequate cognitive function as determined by a Mini-Mental State Examination score of 25 or higher
• Willingness and ability to provide written informed consent

You may not qualify if:

• Presence of objective tinnitus
• History of neurological disorders
• Diagnosed major psychiatric disorders
• Receipt of tinnitus-related treatment within the previous 3 months
• Inability to use or access the smartphone application (for technical or device-related reasons)

Sponsors & Collaborators

• TC Erciyes University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Erciyes University Faculty of Health Sciences

Kayseri, Kayseri, 38000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 7, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)