NCT06829251 Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
| NCT ID | NCT06829251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mersin University |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2025-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2025-02-15 with a primary completion date of 2025-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06829251 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 60 Years, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06829251 currently recruiting?
Yes, NCT06829251 is actively recruiting participants. Contact the research team at ebru33koc@gmail.com for enrollment information.
Where is the NCT06829251 trial being conducted?
This trial is being conducted at Mersin, Turkey (Türkiye).
Who is sponsoring the NCT06829251 clinical trial?
NCT06829251 is sponsored by Mersin University. The trial plans to enroll 62 participants.