Actively Recruiting
Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
Led by Mersin University · Updated on 2025-05-18
62
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to determine the effect of self-administered ear massage on stress, anxiety levels, and sleep quality in parents of children diagnosed with Type 1 diabetes. Additionally, it aims to assess whether ear massage can prevent stress, anxiety, and poor sleep quality. The primary questions it seeks to answer are: H0: There is no significant difference in the mean stress scores between the intervention and control groups of parents. H0: There is no significant difference in the mean anxiety scores between the intervention and control groups of parents. H0: There is no significant difference in the mean Pittsburgh Sleep Quality Index (PSQI) scores between the intervention and control groups of parents. Researchers will compare the effects of ear massage on stress, anxiety levels, and sleep quality with a sham control. Participants: Intervention group: Self-administered effective ear massage twice daily for two weeks, with each session lasting three minutes, totaling 28 sessions. Control group: Self-administered sham ear massage twice daily for two weeks, with each session lasting one minute, totaling 28 sessions. Parents will be reached by sending an invitation letter to the groups they are in on WhatsApp (What's up Application) and Instagram.Volunteer parents will be evaluated for their eligibility criteria and assessed using the 'Depression, Anxiety, Stress Scale-21 (DASS-21)' form. Suitable parents will be sent the informed consent form, personal information form, and 'Pittsburgh Sleep Quality Index'. After the initial data collection, an online ear massage training will be provided. Both groups will receive a 20-minute individual online ear massage training. The Readiness Assessment Form will be used during the training. The application will start the next day. During the implementation process, brochures and video support will be provided by the researcher, and reminder messages will be sent at the times of application. Additionally, participants will be asked to set reminder alarms on their phones. Participants will complete the Ear Massage Tracking Form during the implementation process. At the end of the two-week period, the 'Depression, Anxiety, Stress Scale-21 (DASS-21)' form and the 'Pittsburgh Sleep Quality Index' will be filled out.
CONDITIONS
Official Title
Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parents of children diagnosed with Type 1 diabetes registered in the Mersin Diabetics WhatsApp group, Type 1 Diabetics Instagram association, or diabetes education community forums
- Willing to participate and have signed the informed consent form
- Scoring medium or higher on stress (10 points or more) or anxiety (8 points or more) on the Depression, Anxiety, Stress Scale-21 (DASS-21)
- Prefer ear massage over immediate psychiatric support
- Have facilities to participate in online training (internet and device)
You will not qualify if you...
- Not willing to participate in the study
- Diagnosed psychiatric disorder by a doctor
- Scoring medium or higher on stress or anxiety but prefer immediate psychiatric support over ear massage
- Receiving regular professional psychological support
- Taking antidepressants, anticonvulsants, or sleeping pills
- Pregnant or suspected pregnancy
- Auricular aplasia or hypoplasia (ear deformities)
- Active infection or skin damage in the ear area (ulcer, eczema, urticaria, surgical incision)
- Visual, hearing, or speech impairments
- Receiving regular complementary or alternative treatments for stress, anxiety, or sleep (acupuncture, facial massage, phytotherapy, meditation, breathing exercises)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mersin University Health Sciences Institute Nursing Department Çiftlikköy Campus Yenişehir / MERSİN TURKEY
Mersin, Turkey (Türkiye), 33343
Actively Recruiting
Research Team
E
Ebru Koç, Master's Nursing
CONTACT
S
Sümbüle Köksoy Vayısoğlu, Advisor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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