None listed
Conditions
Brief summary
Aim: These studies aim to investigate the feasibility and acceptability of a novel music and text messaging intervention in individuals with endometriosis. It also aims to evaluate the efficacy of this intervention in improving pain, stress, depression, anxiety and and emotional health-related quality of life. Design: There are 2 phases of this study involving a co-development phase and pilot randomised controlled trial of the intervention. Participants: A total of 62 individuals living with endometriosis (5-6 for co-design of the intervention; and 56 for the pilot trial). Methods: Participants will be asked to listen to self-created music playlist every day for 28 days. Participants will also receive psychologically-focused text messages co-designed to improve management of symptoms/emotional wellbeing (Sherman et al., 2022, 2023, 2024). Participants will complete pre- and post-study surveys, as well as a brief 5-minute survey each day throughout the intervention. Outcome: Participants will perceive the EndoSMS x music intervention as acceptable and feasible.
Interventions
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
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.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed