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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-07

Brief Summary

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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.

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Detailed Description

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This study is a randomized, parallel-group clinical trial designed to evaluate two counseling delivery formats for chronic tinnitus. Eligible adult participants with chronic subjective tinnitus are allocated to either smartphone-based counseling or face-to-face counseling. Both groups receive the same structured counseling content, with the delivery format being the only difference between interventions.

The counseling protocol focuses on tinnitus education, correction of maladaptive beliefs, and development of coping strategies. In the face-to-face group, counseling is delivered through scheduled in-person sessions using a structured educational booklet. In the smartphone-based group, the same content is delivered through a mobile application consisting of sequential modules, including assessment, education, coping strategies, and a clinician support feature.

Participants in both groups complete baseline assessments prior to counseling and follow-up evaluations at two and six weeks. The study is designed to examine whether smartphone-based counseling can achieve outcomes comparable to traditional face-to-face counseling when a unified counseling protocol is applied.

Conditions

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Chronic Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Face-to-Face Counseling

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

Group Type EXPERIMENTAL

Face-to-Face Tinnitus Counseling

Intervention Type BEHAVIORAL

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

Smartphone-Based Counseling

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

Group Type EXPERIMENTAL

Smartphone-Based Tinnitus Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Face-to-Face Tinnitus Counseling

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

Intervention Type BEHAVIORAL

Smartphone-Based Tinnitus Counseling

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No