Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001226493
Ethics application status
Approved
Date submitted
14/03/2016
Date registered
5/09/2016
Date last updated
22/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Negative practice versus repetitive drill: A pilot randomised controlled trial of learning a voice motor skill
Scientific title
Is negative practice more effective in assisting with motor learning of a voice motor skill compared with repetitive drill in the practice phase, among female adults with mildly hyperfunctional vocal patterns?
Secondary ID [1] 288743 0
Nil Known
Universal Trial Number (UTN)
U1111-1180-7021
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Tension Dysphonia 297985 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298137 298137 0 0
Speech therapy
Musculoskeletal 300037 300037 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to practice in one of 3 ways depending on their group allocation :
1) Negative practice condition - produce a dysphonic voice quality then produce a clear, effortless voice quality for 50 trials, 10 times/day for 5 days.
2) Repetitive Drill condition - produce a clear, effortless voice quality for 50 trials, 10 times/day for 5 days.
3) The control group will not practice

The treatment will be delivered by a 4th year student speech pathologist, under the supervision of the chief investigator.

Negative practice or repetitive drill practice group
Participants in the repetitive drill and negative practice groups will attend a 1 hour session at baseline during which time they will listen to scripted instructions that are tailored to their respective treatment group, and a video of an expert clinician modeling the Optimal Phonation Task (OPT). The student investigator will guide the participants through the entire pre-practice phase of learning the OPT and provide feedback where needed. The participants must be able to produce the task such that it approximates the model by the end of this session.

Control group
Participants in the control group will be instructed to complete crosswords to ensure they do not think about or practice the OPT. The investigators will not tell the participants not to think about the OPT because people do not do what they are told and often do the opposite instead (Ovretveit, 2009; Sharp, 1973 as cited in Mayton II, 2009).
Independent practice
After participants master the vocal task during the therapy session, they will move on to the practice phase. This requires them to practice the task 50 times for 10 repetitions a day for five consecutive days in accordance with motor learning recommendations (Maas et al., 2008). Childhood apraxia of speech treatment research guided the investigators in determining the number of trials to be done per practice session (Murray, McCabe, & Ballard, 2012; Maas & Farinella, 2012). The type of practice done by participants will depend on the treatment group they are assigned to. Participants in the control group must not practice the OPT. During each practice session, participants in the repetitive drill group will practice 50 trials of the OPT the correct way (gentle onset, quietly, effortlessly). During each practice session, participants in the negative practice group will practice the wrong way (hard onset, effortful, loud) of performing the OPT immediately followed by the correct way, and think about the difference in sensation in their vocal tract after each set (2 trials), for a total of 50 trials. Both the repetitive drill and negative practice groups will practice a total of 500 trials of the OPT a day.
The entire practice phases will be conducted by participants alone in their own time.

For each practice session, participants must record the time of practice, number of trials completed, practice environment, and effort required to produce the OPT in their individual logbooks. Participants will also need to video record all practice trials they do, so that the investigators can verify that all participants practiced the OPT according to the agreed protocol by reviewing all videos to check the number of trials practiced.
Intervention code [1] 294176 0
Rehabilitation
Comparator / control treatment
The control group will not practice. Following completion of the trial, they will be offered a 1/2 hour treatment session with the chief investigator (a qualified speech pathologist with 15 years experience in voice), and advised to practice according to the outcomes of the study. A follow up to assess progress and need for further intervention will be offered 4 weeks later..
Control group
Active

Outcomes
Primary outcome [1] 297647 0
Clarity of voice as measured perceptually and objectively using acoustic analysis
Timepoint [1] 297647 0
Immediately after 5 days of practice
Secondary outcome [1] 321684 0
Perception of increased ease of vocal production. Participants will also rate the effort required to produce the OPT on a Likert scale.
Timepoint [1] 321684 0
Immediately following 5 days practice

Eligibility
Key inclusion criteria
1. 18-60 years old
2. Female. This will reduce acoustic variability when analyzing outcome measures, and it is also because voice disorders affect females more than males (Roy, 2003).
3. Fluent English speakers
4. Unfamiliar with target vocal task – the OPT
5. Mildly hyperfunctional voices. The term “mildly hyperfunctional” will refer to voices that fulfill the following diagnostic criteria: the participant’s vocal quality when performing the Grandfather Passage, prolonged vowel /a/, and CAPE-V phrases must be rated as “mild” in all categories on the GRBAS and CAPE-V scales by two expert clinicians.
6. Passed hearing and voice screeners
7. No history of a diagnosed organic voice disorder
8. No prior vocal training (e.g. voice therapy, singing or drama lessons; attendance at Voice and Voice Disorders lectures or voice training workshops)
9. No risk factors for an organic voice disorder (e.g. smokers, use of corticosteroids, age of greater than 60 years old)
10. No co-occurring medical conditions and/or use of relevant medication (e.g. high dose of asthma medication)
11. Weekly schedules allow for them to commit to intervention and assessments required for this study
12. Adequate cognitive and communicative abilities required to give informed consent, understand instructions, and report on practice done and practice conditions
13. University of Sydney students
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants that do not meet the above inclusion criteria will be excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants allocated to the control group will be offered course of treatment equivalent to that of the treatment groups after the trial is completed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All collected continuous data will be tested formally on normality using the Kolmogorov-Smirnov test. Based on this outcome, either a parametric or non-parametric test will be used to explore differences between observations. All analyzed data will be presented with mean and median observations, accompanied by standard deviations and variances, as well as the range of collected data.

Correlations between outcomes are determined by calculating the Pearson’s correlation coefficient (r). For the correlation coefficients (r), a minimum value for a strong correlation is set at 0.7 and above. Correlation coefficients between 0.3 and 0.7 will be considered to be a substantial correlation only and r<0.3 will be considered to be a weak correlation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/03/2016
Date of last participant enrolment
Anticipated
2/03/2018
Actual
Date of last data collection
Anticipated
2/05/2018
Actual
Sample size
Target
30
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12918 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 293112 0
University
Name [1] 293112 0
University of Sydney
Country [1] 293112 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
75 East St
Lidcombe 2141
NSW
Country
Australia
Secondary sponsor category [1] 291901 0
Individual
Name [1] 291901 0
Dr Catherine Madill
Address [1] 291901 0
University of Sydney,
75 East St
Lidcombe 2141
NSW
Country [1] 291901 0
Australia
Secondary sponsor category [2] 291902 0
Individual
Name [2] 291902 0
Assoc Prof Patricia McCabe
Address [2] 291902 0
University of Sydney,
75 East St
Lidcombe 2141
NSW
Country [2] 291902 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294611 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294611 0
Ethics committee country [1] 294611 0
Australia
Date submitted for ethics approval [1] 294611 0
09/02/2016
Approval date [1] 294611 0
09/03/2016
Ethics approval number [1] 294611 0
2016/114

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 802 802 0 0
/AnzctrAttachments/370313-Application Outcome 2016_114_1 (2).pdf

Contacts
Principal investigator
Name 64310 0
Dr Catherine Madill
Address 64310 0
Room S176
S Block
Cumberland Campus
University of Sydney
75 East St
Lidcombe 2141 NSW
Country 64310 0
Australia
Phone 64310 0
+61293519692
Fax 64310 0
Email 64310 0
[email protected]
Contact person for public queries
Name 64311 0
Catherine Madill
Address 64311 0
Room S176
S Block
Cumberland Campus
University of Sydney
75 East St
Lidcombe 2141 NSW
Country 64311 0
Australia
Phone 64311 0
+61293519692
Fax 64311 0
Email 64311 0
[email protected]
Contact person for scientific queries
Name 64312 0
Catherine Madill
Address 64312 0
Room S176
S Block
Cumberland Campus
University of Sydney
75 East St
Lidcombe 2141 NSW
Country 64312 0
Australia
Phone 64312 0
+61293519692
Fax 64312 0
Email 64312 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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