Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001252404
Ethics application status
Approved
Date submitted
5/09/2016
Date registered
7/09/2016
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness as a strategy to manage anxiety and maintain golf performance under pressure
Scientific title
The influence of mindfulness training on anxiety and golf performance under pressure
Secondary ID [1] 290076 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Performance Anxiety 300153 0
Condition category
Condition code
Mental Health 300034 300034 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 300035 300035 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individually and via tablet or computer, participants will receive:
- a short video (less than 5 minutes) normalising anxiety and providing information about acceptance of anxiety as an alternative to control
- a section of text (2 paragraphs) linking acceptance and mindfulness to golf performance
- a brief audio recording (less than 5 minutes) containing instructions for a mindfulness exercise: a Body Scan exercise from Gardner and Moore (2007)

Materials will be developed by a Sport Psychologist with more than 5 years experience in mindfulness and acceptance in sport, and reviewed by two senior researchers in the area.

Participants will be exposed to the intervention in a controlled environment while wearing headphones, and be asked to practice mindfulness while the audio recording is playing. They will then be asked to complete the next round of putts while using the skill: "if you become aware of anxiety or doubt coming up, just notice that and focus on the next thing that needs to be done."

The timeline and exposure are as follows:
-Initial questionnaires part 1 (~5 minutes)
-Putting measurement at Time 1 (practice putts; ~5 minutes)
-Initial questionnaires part 2 (~5 minutes)
-Putting measurement at Time 2 (baseline; ~5 minutes)
-Randomise to either Mindfulness first or Control first (~15 minutes)
-Induce pressure ('the following 2 rounds part of competition to earn up to $50')
-Putting measurement at Time 3 (~5 minutes)
-Crossover to either Mindfulness or Control (~15 minutes)**
-Putting measurement at Time 4 (~5 minutes)

**While it is not expected that mindfulness will wash out during this time, it is expected that T3 performance differences be eliminated at T4 once the other group receives mindfulness

Adherence will be assessed by testing state mindfulness directly after the intervention.
Intervention code [1] 295812 0
Treatment: Other
Comparator / control treatment
No Treatment Control
Individually and via tablet or computer, participants will receive:
- a short video (same duration as intervention +/- 10 seconds) from a documentary about a golfer
- a section of text (same length as intervention +/- 50 words) from the transcript of the same documentary
- a brief audio recording (same duration as intervention +/- 10 seconds) from the same documentary
Participants will be exposed to the intervention once in a controlled environment, while wearing headphones, between rounds of putting analysis.
Control group
Active

Outcomes
Primary outcome [1] 299514 0
Golf performance measured via radial error from a series of targets
Timepoint [1] 299514 0
Immediately following intervention and following crossover
Secondary outcome [1] 327491 0
The SAM PuttLab biomechanics output describing the degree of match between this golfer's swing and those of a professional
Timepoint [1] 327491 0
Immediately following intervention and following crossover
Secondary outcome [2] 327492 0
State Mindful Attention Awareness Scale (Brown & Ryan, 2003, adapted for 15 minute intervals)
Timepoint [2] 327492 0
Immediately following intervention and following crossover
Secondary outcome [3] 327510 0
State anxiety via CSAI-2 short form (Cox, Russell & Robb, 1998)
Timepoint [3] 327510 0
Immediately following intervention and following crossover

Eligibility
Key inclusion criteria
Participants will be required to have a golf handicap registered with a club or with Golf Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher conducting the analysis will collect handicap, and therefore inclusion criteria, before the participant is allocated to treatment or control. Allocation will be conducted within the questionnaire software, so neither experimenter nor participant will be aware of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated by Qualtrics software using a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
The outcome assessors nor participants will not be aware of an intervention being provided, and will under the impression the study is about the biomechanics of choking under pressure.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using conservative assumptions (pre-post correlation = 0; mixed anova design, effect sizes estimated partial eta squared =.22 from simple interventions using similar designs; Beilock et al., 2002; Beilock et al., 2006; Beilock et al., 2004) it was estimated approximately 40 experienced golfers (handicap less than or equal to 10) would be required for primary analyses. To allow for mediation and moderation analyses, and to complement another study using the same participants, 128 golfers will be recruited.

To analyse outcomes, primary outcomes will be explored using a linear mixed model: putting attempts will be nested within people over time, comparing baseline with post-intervention and following-crossover. As mentioned earlier, baseline mindfulness practice, dispositional mindfulness and handicap will be entered as moderators, and change in state mindfulness and anxiety will be entered as moderators.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2016
Actual
22/09/2016
Date of last participant enrolment
Anticipated
Actual
8/11/2017
Date of last data collection
Anticipated
Actual
8/11/2017
Sample size
Target
128
Accrual to date
Final
136
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294471 0
University
Name [1] 294471 0
Australian Catholic University
Country [1] 294471 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
25A Barker Rd,
Strathfield, NSW, 2135
Country
Australia
Secondary sponsor category [1] 293340 0
None
Name [1] 293340 0
Address [1] 293340 0
Country [1] 293340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295907 0
Australian Catholic University HREC
Ethics committee address [1] 295907 0
Ethics committee country [1] 295907 0
Australia
Date submitted for ethics approval [1] 295907 0
22/04/2016
Approval date [1] 295907 0
29/06/2016
Ethics approval number [1] 295907 0
2016-109H

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68710 0
Mr Michael Noetel
Address 68710 0
School of Exercise Science
Australian Catholic University
163-167 Albert Rd
Strathfield, NSW, 2135
Country 68710 0
Australia
Phone 68710 0
+61297014019
Fax 68710 0
Email 68710 0
[email protected]
Contact person for public queries
Name 68711 0
Michael Noetel
Address 68711 0
School of Exercise Science
Australian Catholic University
163-167 Albert Rd
Strathfield, NSW, 2135
Country 68711 0
Australia
Phone 68711 0
+61297014019
Fax 68711 0
Email 68711 0
[email protected]
Contact person for scientific queries
Name 68712 0
Michael Noetel
Address 68712 0
School of Exercise Science
Australian Catholic University
163-167 Albert Rd
Strathfield, NSW, 2135
Country 68712 0
Australia
Phone 68712 0
+61297014019
Fax 68712 0
Email 68712 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.