Wan Salleh, Wan Suhailah Wan Husain
(2016)
Development and clinical trials of psycho-audiological module (PAM) as an intervention for patients with tinnitus.
Masters thesis, Pusat Pengajian Sains Perubatan.
Abstract
Tinnitus is a common symptom among otological patients and serious if untreated. The
main focus of the present study was to develop a new intervention, known as Psycho-
Audiological Module (PAM), for treating tinnitus. This study had three consecutive
phases: Phase I was about determining the current tinnitus management by ORL
specialists, audiologists and medical officers in Malaysia, Phase II was about the
development and validation of PAM and the effectiveness of PAM intervention in
treating patients with tinnitus (relative to broadband masker intervention, BBM) was
studied in Phase III.
In Phase I, 212 validated questionnaires were sent to 16 hospitals. A good response rate
was obtained (51.8%) enabling detailed analysis of the survey outcomes. It was found
that pure tone audiometry and tympanometry were the routine assessments performed in
most ORL and audiology clinics for patients with tinnitus. Pharmacotherapy and
hearing aid fitting were the most common treatments offered to the patients.
Nevertheless, the majority of respondents were not satisfied with their current practice
and they looked forward to have one standard guideline for managing patients with
tinnitus in a more effective manner.
In Phase II, the PAM was developed based on extensive literature review and
discussions among the relevant experts including a clinical psychologist. It consists of
four specific parts with the general aim to guide patients with tinnitus in the habituation
process. The newly developed PAM was then validated by the experts and patients with
tinnitus.
In Phase III, a clinical trial to justify the effectiveness of PAM intervention to treat
patients with tinnitus was carried out in 28 participants with complaint of tinnitus. The
changes between pre- and post-intervention (2 weeks, 3 months and 6 months) sessions
were assessed by Borang Evaluasi Soal selidik Tinnitus (BEST), Bahasa Malaysia
Depression, Anxiety and Stress Scale 21 (BM DASS 21) and tinnitus psychoacoustic
measures. While both interventions were found to be effective, the PAM intervention
was superior in reducing tinnitus severity with a large effect size (r=0.531) relative to
the control group (BBM, n=28) (r = 0.370). Furthermore, the effectiveness of PAM
intervention was more evident by looking at the number of participants with clinical
significant reduction in the perceived tinnitus severity. At 2 weeks after intervention,
32% of participants revealed clinical significant reduction and the number increased to
64% at 6 months follow-up. The PAM intervention was also effective in reducing
perceived psychological symptoms. At 6 months follow-up, the number of participants
with clinical significant reduction could be as high as 32%. On the other hand, no
significant changes were seen in tinnitus loudness and minimum masking level in the
PAM group. Due to its superior performance, PAM intervention should be used in
clinical setting for managing patients with tinnitus in a structured manner.
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