Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000570482
Ethics application status
Approved
Date submitted
6/05/2025
Date registered
3/06/2025
Date last updated
3/06/2025
Date data sharing statement initially provided
3/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot and evaluation of a music and text message intervention for people with endometriosis
Scientific title
Acceptability and feasibility of a music and text message intervention for people with endometriosis: A pilot randomised controlled trial
Secondary ID [1] 314182 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 337040 0
Condition category
Condition code
Reproductive Health and Childbirth 333487 333487 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1: consumer panel
A consumer panel will be recruited to provide feedback on the newly developed text messages for the EndoSMS intervention. They will provide ratings on the appeal, readability, and appropriateness of the text messages. This will occur approximately one month prior to phase 2 to allow time for feedback and revision of the newly developed text messages.

Phase 2: Pilot Randomised Controlled Trial
Participants will be randomised to one of two conditions - intervention or control. Intervention participants will be asked to create a 20-minute music playlist of songs they find calm/relaxing and would be happy to listen to daily, on their preferred music streaming service (e.g., Spotify, Apple Music). They will be asked to send a screenshot of this playlist to researchers to verify compliance with this instruction. Additionally, intervention participants will receive access to EndoSMS, a psychologically-focused text message intervention for people with endometriosis (Sherman et al., 2022, 2023, 2024). To allow a tailored approach, participants in this group will choose topics of text messages (2 minimum, and 4 maximum) from a set provided via a Qualtrics survey. These topics include categories such as self-care, sleep, physical health, and emotional wellbeing, with messages such as “Not sleeping well? While alcohol may help you fall asleep initially, it can disrupt the sleep cycle. For a better sleep, avoid alcohol 2 hours before bedtime., “Some days are harder than others, . Consider contacting a friend if you're having a tough day”. These are one-way text messages, meaning participants are not required to respond. Participants will receive 4 text messages during the week at a preferred time of day (morning or afternoon) and be additionally asked to listen to their self-created playlist once a day. This will be done for a period of 28 days. During this time, these participants will manage their endometriosis and symptoms as usual, for example, taking hormonal medication, complementary therapies, or self-management techniques.

Adherence will be assessed in the intervention group through ecological momentary assessment (EMA), with a daily survey asking participants to note whether they listened to their playlist.
Intervention code [1] 330783 0
Behaviour
Intervention code [2] 331112 0
Treatment: Other
Comparator / control treatment
Control group participants will complete all study surveys over the 28 day period of the study and upon completion will be offered access to the intervention for a period of 28 days. No further assessment will be undertaken for this group. During the trial period, control participants will manage their endometriosis and symptoms as they usually would including medical management (hormonal medications, pain killers), complementary therapies, or self-management strategies.
Control group
Active

Outcomes
Primary outcome [1] 341067 0
Feasibility - Adherence
Timepoint [1] 341067 0
Daily for 28 days (from day 0 to day 28), post-intervention (at Day 28 post-intervention commencement)
Primary outcome [2] 341068 0
Acceptability
Timepoint [2] 341068 0
Post-intervention (at Day 28 post-intervention commencement).
Primary outcome [3] 341549 0
Feasibility - Ease of Use
Timepoint [3] 341549 0
Post-intervention (at Day 28 post-intervention commencement).
Secondary outcome [1] 446028 0
Pain
Timepoint [1] 446028 0
Baseline (Day 0), daily for 28 days, Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [2] 446029 0
Emotional health-related quality of life
Timepoint [2] 446029 0
Baseline (Day 0), daily for 28 days, Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [3] 446031 0
Symptom impact
Timepoint [3] 446031 0
Baseline (Day 0), Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [4] 447197 0
Depression
Timepoint [4] 447197 0
Baseline (Day 0), daily for 28 days, Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [5] 447198 0
Anxiety
Timepoint [5] 447198 0
Baseline (Day 0), daily for 28 days, Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [6] 447199 0
Stress
Timepoint [6] 447199 0
Baseline (Day 0), daily for 28 days, Post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [7] 447907 0
Feasibility - Retention
Timepoint [7] 447907 0
Screener survey (during recruitment), baseline (Day 0), daily for 28 days, post-intervention (at Day 28 post-intervention commencement)
Secondary outcome [8] 447908 0
Feasibility - Delivery System Usage
Timepoint [8] 447908 0
Post-intervention (at Day 28 post-intervention commencement).

Eligibility
Key inclusion criteria
1) self-reported clinical/medical diagnosis of endometriosis, 2) female assigned at birth, 3) access to a music streaming service, 4) ability to receive text messages, 5) proficiency in English, 6) living in Australia at the time of conducting the study, 7) be aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) no diagnosis of endometriosis, 2) male assigned at birth, 3) no access to a music streaming service, 4) inability to receive text messages, 5) not proficient in English, 6) living outside of Australia at the time of conducting the study, 7) be aged under 18 years old.

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)
Random allocation will be conducted by using randomizer.org after eligibility has been assessed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study, the current study does not require formal hypothesis testing and therefore does not require a power analysis (Eldridge et al., 2016). 5-6 participants will be recruited for the consumer panel, and for the pilot study, as per the CONSORT pilot study guidelines, we have not conducted a power analysis (Eldridge et al., 2016). 56 participants is regarded as an achievable sample size given constraints of time and funding in this pilot project.

Data will be analysed using STATA and NVivo (for qualitative feasibility and acceptability responses). Initial descriptive analyses of demographic and medical characteristics and bivariate associations of these variables with the study outcomes will be undertaken to identify possible covariates using Pearson’s correlation (continuous variables) and chi-square analyses (categorical variables). Feasibility and acceptability quantitative data will be assessed by comparing the means and standard deviations of the outcomes. Qualitative data will be thematically analysed using NVivo software to identify themes across participants for refinement of the intervention at each phase. To analyse preliminary efficacy of the intervention, a between subjects ANOVA will be completed to compare the groups on each outcome variable (pain, stress, depression, anxiety, emotional health-related QoL, and symptom impact). For the pilot trial of EndoSMS x Music, differences between allocated groups for preliminary efficacy outcomes will be assessed post-intervention via independent samples T-tests for normally distributed continuous variables (Mann–Whitney U-test if not normally distributed). Where appropriate, confidence intervals will be considered to provide indicative efficacy (Eldridge et al., 2016). To analyse EMA data, mixed linear models will be used for each outcome to account for the influence of correlation between participants’ repeated observations (Oleson et al., 2021).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/06/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318698 0
University
Name [1] 318698 0
Macquarie University
Country [1] 318698 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 321129 0
None
Name [1] 321129 0
Address [1] 321129 0
Country [1] 321129 0
Other collaborator category [1] 283516 0
University
Name [1] 283516 0
University of Vienna
Address [1] 283516 0
Country [1] 283516 0
Austria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317307 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 317307 0
Ethics committee country [1] 317307 0
Australia
Date submitted for ethics approval [1] 317307 0
17/03/2025
Approval date [1] 317307 0
06/05/2025
Ethics approval number [1] 317307 0
520251898162646

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

Contacts
Principal investigator
Name 140642 0
Prof Kerry Sherman
Address 140642 0
16 University Ave, Macquarie University NSW 2113
Country 140642 0
Australia
Phone 140642 0
+61 2 9850 6874
Fax 140642 0
Email 140642 0
[email protected]
Contact person for public queries
Name 140643 0
Kerry Sherman
Address 140643 0
16 University Ave, Macquarie University NSW 2113
Country 140643 0
Australia
Phone 140643 0
+61 2 9850 6874
Fax 140643 0
Email 140643 0
[email protected]
Contact person for scientific queries
Name 140644 0
Kerry Sherman
Address 140644 0
16 University Ave, Macquarie University NSW 2113
Country 140644 0
Australia
Phone 140644 0
+61 2 9850 6874
Fax 140644 0
Email 140644 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Highly sensitive data.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  [email protected] Project Description_V4_09.04.25_CLEAN.docx
Ethical approval    Letter.pdf
Informed consent form    EndoSMSxMusic_PICF_v2_CLEAN.docx


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.