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Trial registered on ANZCTR
Registration number
ACTRN12624000950561p
Ethics application status
Not yet submitted
Date submitted
2/07/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The EndoChill Trial: Evaluating the safety and efficacy of the Wim Hof Method for endometriosis pain
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Scientific title
A single case experimental design trial evaluating the efficacy and safety of the Wim Hof Method for systemic inflammation and pain in people with endometriosis
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Secondary ID [1]
312435
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
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Endometriosis-associated pain
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Condition category
Condition code
Alternative and Complementary Medicine
330921
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0
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Other alternative and complementary medicine
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Reproductive Health and Childbirth
331004
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0
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Other reproductive health and childbirth disorders
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Reproductive Health and Childbirth
331005
331005
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0
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Menstruation and menopause
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Once enrolled into the study, participants will follow a three-phase study procedure (baseline, intervention, and follow-up) which will entail the following:
Baseline Phase:
Participants will undergo an eTVUS (transvaginal ultrasound for endometriosis) scan to establish their initial endometriosis lesion characteristics. This will form part of the inclusion and exclusion criteria with only participants that have endometriosis lesions visible by eTVUS included in the study.
Participants will complete daily pelvic pain ratings for the duration of the study, specifically using an 11-point numerical rating scale (NRS) via the Ethica app on their mobile device.
A second eTVUS will be completed in the week prior to the intervention phase. A blood sample will be collected on the same day as the second eTVUS to assess sympathetic nervous system function, hormone levels, and innate immune responses. Participants will also complete the Pelvic Pain Impact Questionnaire (PPIQ) and Pelvic Pain Psychological Screening Questionnaire (3PSQ) using the Ethica App. These questionnaires will be used to measure physical and psychological impacts of pain associated with endometriosis.
The baseline phase of the study will vary in length from 1 to 6 weeks based upon participant randomisation.
Intervention Phase:
The Wim Hof Method (WHM) is a novel intervention that combines breathing exercises, mindfulness, and cold exposure therapy to improve health outcomes.
At the beginning of the intervention phase, participants will attend (in small groups of 4 to 6 people) one training workshop introducing the WHM, including correct technique and safety requirements (3 hours duration). These workshops will be conducted by a trained instructor.
Participants will then continue to practice the WHM daily at home for 12 weeks, guided and recorded via the WHM app. In addition, participants will have the option to attend up to 2 x 1-hour supervised WHM sessions per week during the intervention phase.
During intervention weeks 6 (mid-intervention) and 12 (end-intervention), participants will attend a supervised WHM session. A blood sample will be collected on each of these visits to assess sympathetic nervous system function, hormone levels, and innate immune responses. Participants will also complete the PPIQ and 3PSQ.
Participants will continue recording daily pelvic pain ratings via the Ethica app.
Follow-up Phase:
Participants will continue recording daily pelvic pain ratings via the Ethica App and engage in WHM via the WHM app for a further 8 weeks after the intervention phase.
In the final week of the follow-up phase, participants will undergo an eTVUS scan, blood sample collection to assess sympathetic nervous system function, hormone levels, and innate immune responses, and will complete the PPIQ and 3PSQ. These data will be used to evaluate long-term effects of the WHM intervention.
Study locations:
The site for eTVUS scanning will be Specialist Imaging Partners in North Adelaide. Blood samples, and completion of the PPIQ and 3PSQ, will also take place here during the baseline and follow-up phases.
All WHM workshops, supervised WHM sessions, and the mid- and end-intervention measurements (blood samples, PPIQ and 3PSQ) will take place at the Clinial Research Facility at the University of Adelaide Health and Medical Sciences Building (AHMS) situated on North Terrace, Adelaide CBD.
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Intervention code [1]
328939
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Treatment: Other
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Comparator / control treatment
This trial employs a single-case experimental design (SCED) with randomised multiple baselines. Each of the 32 participants will serve as their own control, allowing for intensive study from baseline, intervention, and through to the follow-up period.
Study duration: The baseline phase will take from 1 to 6 weeks depending upon which group participants are randomised into and to help stagger the start time for small groups of 4 to 6 participants. The intervention phase will be 12 weeks, and the follow-up phase will be 8 weeks following completion of the intervention phase.
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Control group
Active
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Outcomes
Primary outcome [1]
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Pelvic pain
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Assessment method [1]
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11-point numerical rating scale (NRS) for pelvic pain answered daily by participants using the Ethica app.
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Timepoint [1]
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Participants to register daily pelvic pain scores for the study duration (baseline, intervention, and follow-up phases).
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Primary outcome [2]
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Pelvic pain lifestyle impact
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Assessment method [2]
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Pelvic Pain Impact Questionnaire (PPIQ) answered by participants using the Ethica app.
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Timepoint [2]
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PPIQ completed once at baseline, mid-intervention (intervention week 6), end-intervention (intervention week 12) and follow-up (8 weeks post-intervention phase).
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Primary outcome [3]
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Pelvic pain psychological impact
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Assessment method [3]
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Pelvic Pain Psychological Screening Questionnaire (3PSQ) answered by participants using the Ethica app.
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Timepoint [3]
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3PSQ completed once at baseline, mid-intervention (intervention week 6), end-intervention (intervention week 12) and follow-up (8 weeks post-intervention phase).
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Secondary outcome [1]
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Endometriosis lesion size
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Assessment method [1]
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Specialist transvaginal ultrasound for endometriosis (eTVUS) measurement of lesion size and grade.
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Timepoint [1]
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Transvaginal ultrasound for endometriosis (eTVUS) will be carried out at three major time-points:
1. During the baseline phase, forming part of the participant inclusion/exclusion criteria (i.e., participants will be included if lesions are visible on scan).
2. Just prior to commencing the intervention phase (i.e., exposure to WHM training sessions).
3. At the end of the follow-up phase (i.e., 8 weeks post-intervention phase), to determine if the WHM has had an appreciable change on lesion characteristics.
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Secondary outcome [2]
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Blood plasma levels of adrenaline, noradrenaline, adrenocorticotropic hormone (ACTH) and cortisol, assessed as a composite outcome by multiplex assay.
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Assessment method [2]
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Enzyme-linked immunosorbent assay (ELISA).
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Timepoint [2]
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Single blood samples will be obtained at baseline, mid-intervention (intervention week 6), end-intervention (intervention week 12) and follow-up (8 weeks post-intervention phase).
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Secondary outcome [3]
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Safety of the WHM for endometriosis
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Assessment method [3]
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As part of the exclusion criteria, participants will be screened for pre-existing health conditions that may increase the risk of an adverse event. For example, coronary heart disease or cold urticaria. Participants with evidence of such pre-existing health conditions will not be included in the study.
Known or possible adverse events related to the WHM include: hyperventilation (due to rapid breathing techniques); hypoxia (due to extended breath holding); cold-related injuries (due to cold exposure therapy); psychological distress (due to intensity of breathing techniques and/or cold exposure therapy); and overexertion (also due to intensity of breathing/cold exercises without adequate rest).
Participants will be made aware of these conditions and encouraged to self-report symptoms to trial staff during supervised WHM workshops and/or while performing WHM at home.
During the WHM workshops, participants will be observed by trial staff (WHM trainer, study coordinators, and the trial nurse) and will have their vital signs checked. These include: core temperature (recorded by oral thermometer); heart rate and blood oxygen saturation (measured by pulse oximeter); and blood pressure (monitored via electronic sphygmomanometer). This will be used to assess participant readiness for the WHM workshops and to clinically examine participants in cases of suspected adverse events. All trial staff have current first-aid certificates including acute resuscitation training.
When performing WHM at home, participants can contact the study coordinators at any time via phone or email to advise of adverse events. They will be instructed to cease performing WHM and to seek medical attention if required, prior to re-engaging in the study.
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Timepoint [3]
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Participant safety will be monitored throughout the study at all time-points. During the WHM workshops, participants will have vital signs checked (core temperature, heart rate, blood oxygen saturation, blood pressure) and will be observed by trial staff (WHM trainer, study coordinators, and the trial nurse). Participants can contact the study coordinators via phone or email at any time when performing WHM at home to report adverse events and will be encouraged to seek medical attention if required.
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Eligibility
Key inclusion criteria
Diagnosis of endometriosis (according to European Society and Human Reproduction and Embryology (ESHRE) guidelines)
Endometriosis lesions visible on eTVUS scan
Aged 18 years or older
Rate average period pain over past two menstrual cycles as at least 3/10 on an 11-point numerical rating scale (NRS)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Health conditions contraindicating participation in WHM training (e.g., coronary heart disease, cold urticaria etc.)
Are pregnant
Have had surgery in the past 6 months
Are intending to have surgery (e.g., laparoscopy for endometriosis) over the duration of the trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
This is an experimental study featuring a non-concurrent, randomised multiple-baseline across subjects design followed by application of a single intervention (The Wim Hof Method)
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Safety outcomes will be analysed descriptively, with the numbers, proportions, and descriptions of any adverse events reported.
Feasibility outcomes will be analysed descriptively (for quantitative outcomes) or through content analysis (for qualitative data).
Efficacy outcomes will be analysed descriptively and visually (for all data), in line with recommendations in the literature. Pain data will also be statistically analysed using a multivariate test statistic.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last data collection
Anticipated
31/05/2025
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Actual
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Sample size
Target
32
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
316853
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Charities/Societies/Foundations
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Name [1]
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Wilson Foundation
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Adelaide
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
319097
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Country [1]
319097
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee L
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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15/08/2024
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Approval date [1]
315613
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Ethics approval number [1]
315613
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Summary
Brief summary
The primary aim is to determine the safety, feasibility, and efficacy of the Wim Hof Method (WHM) for the treatment of pain associated with endometriosis. The study will measure self-reported pain and biological markers of inflammation. Objectives include assessing the impact of WHM on pelvic pain, psychological status, endometriosis lesion characteristics, autonomic nervous system, endocrine system responses and innate immune system responses.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Mark Hutchinson
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Address
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The University of Adelaide, School of Medical Sciences, 30 Frome Road, Adelaide SA 5005.
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Country
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Australia
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Phone
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+61 8 8313 0322
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Kelsi Dodds
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Address
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The University of Adelaide, School of Medical Sciences, 30 Frome Road, Adelaide SA 5005.
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Country
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Australia
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Phone
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+61 8 8313 7198
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Joshua Woenig
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Address
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The University of Adelaide, School of Medical Sciences, 30 Frome Road, Adelaide SA 5005.
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Country
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Australia
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Phone
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+61 8 8313 4261
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual data will not be shared due to the nature of the data and to respect the privacy and confidentiality of all participants.
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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.
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