Ear massage to reduce stress, anxiety, and improve sleep in parents of children with Type 1 diabetes
The Effect of Self-Administered Ear Massage on Stress, Anxiety Levels, and Sleep Quality in Parents of Children Diagnosed With Type 1 Diabetes
This study is testing if giving themselves ear massages can help parents of children with Type 1 diabetes feel less stressed and anxious, and sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Mersin University Academic / other |
| Locations | 1 site (Mersin) |
| Trial ID | NCT06829251 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of self-administered ear massage on stress, anxiety levels, and sleep quality in parents of children diagnosed with Type 1 diabetes. Participants will engage in ear massage sessions twice daily for two weeks, with outcomes measured against a sham control group. The study aims to determine if ear massage can significantly improve mental health and sleep quality in this population, who often experience heightened stress and anxiety due to their caregiving responsibilities. The primary outcomes will be assessed using validated scales for stress, anxiety, and sleep quality.
Who should consider this trial
Good fit: Ideal candidates are parents of children with Type 1 diabetes who experience moderate to high levels of stress and anxiety.
Not a fit: Patients who do not experience significant stress or anxiety, or those who prefer immediate psychiatric support, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a simple, non-pharmacological method for parents to manage stress and improve their overall well-being.
How similar studies have performed: While the specific approach of ear massage is less commonly studied, similar non-pharmacological interventions have shown promise in reducing stress and improving sleep quality in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Between February 2025 and July 2025, parents of children diagnosed with Type 1 diabetes, who are registered in the Mersin Diabetics group on WhatsApp (What's up Application), the Type 1 Diabetics association on Instagram, and the community forums and groups of diabetes education nurses and dietitians, will be eligible to participate in the study. * Those who are willing to participate in the study and have signed the informed consent form * Those who score medium or higher \[stress (10 points or more) or anxiety (8 points or more)\] on the Depression, Anxiety, Stress Scale-21 (DASS-21) and prefer to perform ear massage first over immediately receiving psychiatric support * Those who have the facilities to participate in online training (internet, phone/tablet/computer, etc.) will be included in the sample. Exclusion Criteria: Between February 2025 and July 2025, parents of children diagnosed with Type 1 diabetes, who are registered in the Mersin Diabetics group on WhatsApp (What's up Application), the Type 1 Diabetics association on Instagram, and the community forums and groups of diabetes education nurses and dietitians, will be eligible to participate in the study. * Those who are not willing to participate in the study * Those with a psychiatric diagnosis made by a doctor * Those who score medium or higher \[stress (10 points or more) or anxiety (8 points or more)\] on the DASS-21 scale, but prefer to receive psychiatric support first over ear massage after immediately receiving psychiatric support * Those receiving regular professional psychological support * Those taking antidepressants, anticonvulsants, or sleeping pills * Pregnant women or those suspected of being pregnant * Those with auricular aplasia or hypoplasia * Those with active infection or disruption of skin integrity in the ear area (ulcer, eczema, urticaria, surgical incision, etc.) * Those with visual, hearing, or speech impairments * Those receiving regular complementary or alternative treatments for stress, anxiety, and sleep (acupuncture, facial massage, phytotherapy, meditation, breathing exercises, etc.) will not be included in the sample.
Where this trial is running
Mersin
- Mersin University Health Sciences Institute Nursing Department Çiftlikköy Campus Yenişehir / MERSİN TURKEY — Mersin, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ebru Koç, Master's Nursing
- Email: ebru33koc@gmail.com
- Phone: +90 534 820 01 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.