Clinical investigation protocol for tinnitus (CIP-t): development and validation of an instrument

Moreira, Hélinton Goulart; Garcia, Michele Vargas

doi:10.1590/2317-1782/e20250125pt

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Original Article • CoDAS 38 (3) • 2026 • https://doi.org/10.1590/2317-1782/e20250125en linkcopy

Clinical investigation protocol for tinnitus (CIP-t): development and validation of an instrument

Authorship SCIMAGO INSTITUTIONS RANKINGS

Purpose The objective of this study was the development and validation of a clinical investigation protocol for tinnitus and the analysis of its applicability.

Methods The research was conducted in eight stages: Stage 1: Literature review and development of the pilot protocol; Stage 2: Expert judges I – first analysis/evaluation; Stage 3: Elaboration of the unified investigation protocol and the application guide; Stage 4: Expert judges II – second analysis/evaluation of the instruments from the previous stage; Stage 5: Refinement of materials; Stage 6: Application of the protocol by expert and non-expert clinicians; Stage 7: Final construction; Stage 8: Pilot study – convenience sample. The results of each stage were compiled into an Excel spreadsheet for specific analyses (content validity ratio calculation and suggestions).

Results The structure of the protocol was successfully developed, resulting in a unified instrument subdivided into: tinnitus-focused anamnesis, audiological, emotional, metabolic, somatosensory, and vascular history, assessment results, a framework for subgroup classification, clinical decision tree, and complementary evaluations. The protocol was applied to a sample of 83 adults and older individuals.

Conclusion The clinical investigation protocol for tinnitus was finalized and its content validated, demonstrating applicability for adult and elderly individuals with tinnitus.

Keywords:
Tinnitus; Protocol; Assessment; Adults; Older Adults

CONTENT CONSTRUCTION AND VALIDATION
Phases	Stages	Participant	Selection criteria
Phase 1	Stage 1: Literature review and development of the pilot protocol	02 speech therapists	Study authors.
	Step 2: Expert judges I - first analysis/evaluation of the pilot protocol	03 speech therapists 01 physical therapist 01 physician	Doctors with at least 10 years of clinical and research experience, all in the field of tinnitus.
	Stage 3: Development of a single research protocol and application guide.	02 speech therapists	Authors of the study.
Phase 2	Stage 4: Expert judges II - second analysis/judgment of the protocol and application guide (same as in stage 2)	03 speech therapists 01 physical therapist 01 physician	Doctors with at least 10 years of clinical experience, all in the field of tinnitus.
	Stage 5: Adjustments to the protocol and application guide.	02 speech therapists	Authors of the study.
	Stage 6: Specialist and non-specialist judges - clinical application	Specialists: 04 speech therapists 01 physical therapist Non-specialists: 04 speech therapy students 01 medical student	Professionals with at least 2 years of clinical experience in audiology or tinnitus. Students with less than one year of experience with tinnitus.
	Stage 7: Final construction of the CIP-t	02 speech therapists	Authors of the study.
Phase 3	Stage 8: Pilot study - convenience sample	83 individuals	Adults and elderly individuals, aged between 17 and 80 years, with perception of tinnitus.

Category	Description	N (total subjects)
Location	Head	9
	Right ear	7
	Left ear	12
	Bilateral	11
	Both, worse on the right	30
	Both, worse on the left	14
Type of perception	Single	71
Type of perception	Multiple	12
Single perceptions (n=71)	Whistle	23
	Cicada/Cricket**	12 (each)
	Bee	6
	Hissing / Pressure cooker**	4 (each)
	Waterfall	2
	Ambulance / bee wing / heart / motor / breath / tractor / jet turbine / windstorm**	1 (each)
Multiple perceptions (n=12)	Cicada + whistle	4
	Whistle + cricket	3
	Cricket + Cicada	2
	Whistle + pressure cooker	1
	Waterfall + Bee	1
	Waterfall + Cricket	1
Tonal frequency of the buzzing sound	High	57
	Medium	16
	Low	10

Measure	Mean	Minimum	Maximum	Standard deviation
VAS- Discomfort	6.84	2	10	3.56
VAS- Loudness	6.49	2	10	3.41
THI- total	46.77	10	100	21.73
THI- functional	19.90	4	44	12.59
THI - emotional	17.24	0	38	11.22
THI- catastrophic	10.80	0	40	7.48

SUBGROUPS
	Total number of subjects	Thresholds up to 8kHz	N	%
HEARING	83	Normal	13	15.66
HEARING	83	Impaired	70	84.34
	Total number of subjects	Emotional screening	N	%
EMOTIONAL	83	Normal	12	14.46
EMOTIONAL	83	Altered	71	85.54
	Total number of subjects	Laboratory tests	N	%
METABOLIC	13	Normal	1	7.70
METABOLIC	13	Altered	12	92.30
	Total number of subjects	Muscular influence	N	%
SOMATOSENSORY	83	No	50	60.24
SOMATOSENSORY	83	Yes	33	39.76
	Total number of subjects	Vascular influence	N	%
VASCULAR	83	No	83	100
VASCULAR	83	Yes	0	0

HEARING SUBGROUP
	Total number of subjects	Ears	N	%
Location	70	RE	3	4.29
		LE	2	2.86%
		BE	65	92.85%
	Total number of ears	Type	N	%
Right ear	68	Sensorineural	37	54.41
		Conductive	0	0
		Mixed	5	7.35
		Frequencies	28	38.24
Left ear	67	Sensorineural	39	58.21
		Conductive	2	2.99
		Mixed	5	7.46
		Frequencies	21	31.34%
	Total number of ears	Grade *	N	%
Right ear	68	Mild	27	67.50
		Moderate	5	12.50
		Moderately severe	4	10
		Severe	1	2.50
		Profound	2	5.00
		Complete/deaf	1	2.50
		Total number of changes	40	100
	Total number of ears	Grade*	N	%
Left ear	67	Mild	29	67.44
		Moderate	7	16.28
		Moderately severe	3	6.98
		Severe	4	9.30
		Profound	0	0
		Complete/deaf	0	0
		Total number of changes	43	100
	Total number of ears	Frequencies (Hz)	N	%
Right ear	68	250	9	10.34
		500	7	8.04%
		1000	0	0
		2000	9	10.34
		3000	11	12.64
		4000	17	19.55
		6000	18	20.67
		8000	16	18.39
		Total number of changes	87	100
	Total number of ears	Frequencies (Hz)	N	%
Left ear	67	250	4	5.00
		500	3	3.75%
		1000	0	0
		2000	3	3.75
		3000	14	17.50
		4000	19	23.75
		6000	19	23.75%
		8000	18	22.50
		Total number of changes	80	100

EMOTIONAL SUBGROUP
	Total number of subjects	Complaints	N	%
Medical history	71	No complaints	17	16.50
		Anxiety	44	42.72
		Stress	14	13.59
		Depression	19	18.45
		Panic/fear/phobia	8	7.77
		Other	1	0.97
		Total number of complaints	103	100

Hospital Anxiety and Depression Scale (HADS)
Analyses	Total N	Mean	Minimum-Maximum	Standard deviation
Total	71	15.28	1 -30	9.35
Anxiety		8.42	0 - 16	5.0
Depression		6.86	0 - 17	4.87

METABOLIC SUBGROUP
	Total number of subjects	Laboratory tests	N	%
Laboratory rates	12	Complete blood count	3	12
		Blood sugar	2	8
		Cholesterol	5	20
		Triglycerides	2	8
		Glucose	2	8
		TSH	2	8
		Cortisol	1	4
		Iron	1	4
		Ferritin	1	4
		Vitamin C	1	4
		Vitamin D	4	16
		Zinc	1	4%
		Total Fees	25	100

SOMATOSENSORY SUBGROUP
	Total number of subjects	Complaints	N	%
Medical history	33	Pain	23	40.35
		Blood pressure	8	14.04
		Bruxism	9	15.77
		TMD	13	22.80
		Modulation	4	7.02
		Total complaints	57	100

SOMATOSENSORY SUBGROUP
	Total number of subjects	Points	N	%
Acupressure/palpation	33	Masseter	13	7.30
		Lateral pterygoid	9	5.06
		Medial pterygoid	8	4.49
		Pre- and post-auricular temporal	20	11.24
		Front	7	3.93
		Temporal tendon (TMJ)	18	10.11
		Zygomatic	6	3.37
		Digastric	5	2.80
		Buccinator	6	3.38
		Orbiculares	3	1.68
		Geniohyoid	2	1.12
		Long neck	9	5.05
		Sternocleidomastoid	6	3.37
		Mastoid	17	9.55
		Scalene	6	3.38
		Scapula lifter	5	2.80
		Rhomboid	5	2.80
		Suboccipital muscles	10	5.62
		Splenium	9	5.06
		Trapezius and spinous processes	14	7.87
		Total modulations	178	100%
	Total number of subjects	Movements	N	%
Mandibular movements	33	Closing eyes tightly	9	9.09
		Teeth clenching	9	9.09
		Mandibular retrusion	8	8.08
		Opening without resistance	6	6.06
		Opening with resistance	11	11.11
		Protrusion without resistance	5	5.05
		Protrusion with resistance	8	8.08
		Right lateralization without resistance	11	11.11
		Right lateralization with resistance	13	13.13
		Left lateralization without resistance	9	9.09
		Right lateralization with resistance	10	10.11
		Total modulations	178	100
	Total number of subjects	Movements	N	%
Cervical movements	33	Flexion	4	17.39
		Extension	5	21.74
		Rightward tilt	8	34.78
		Leftward tilt	6	26.09
		Total modulations	23	100
	Total number of subjects	Movements	N	%
Eye movements	33	Horizontal pursuit	6	17.65
		Vertical pursuit	7	20.59
		Lateralization to the right	6	17.65
		Left lateralization	5	14.71
		Upper verticalization	3	8.82
		Lower verticalization	4	11.76
		Convergence	3	8.82
		Total modulations	34	100

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[1] Caption: CIP-t = Clinical Investigation Protocol for tinnitus