Clinical trial NCT06829251: Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
Official title: The Effect of Self-Administered Ear Massage on Stress, Anxiety Levels, and Sleep Quality in Parents of Children Diagnosed With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Sleep Quality
Keywords: Ear Massage
Stress
Anxiety
Sleep Quality
Tip-1 Diabetes Mellitus
Parents
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is designed as a single-blind, randomized, sham-controlled, interventional research to determine the effect of self-administered effective ear massage on stress, anxiety levels, and sleep quality in parents of children diagnosed with Type 1 diabetes. Participants in the intervention group will perform effective ear massage, while participants in the control group will receive sham ear massage that mimics the intervention but does not stimulate pressure points.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Type 1 diabetes is a chronic metabolic disease characterized by insulinopenia and hyperglycemia, resulting from the destruction of pancreatic beta cells responsible for insulin production due to autoimmune or non-autoimmune causes in the childhood group \[1\]. Since Type 1 diabetes is mostly diagnosed at a young age, parents have significant responsibilities in the management and care of Type 1 diabetes \[2\]. The need for continuous 24-hour care leads to parents being detached from their social life, experiencing increased stress and anxiety levels, and reduced sleep quality \[2\]. Research indicates that approximately 20% to 30% of parents of children diagnosed with Type 1 diabetes report clinically significant stress (life stress or parenting stress), anxiety, depression, and post-traumatic stress symptoms \[3,4, 5\]. Additionally, studies have shown that 76% of parents experience clinically significant sleep disorders \[6\].

When parents cannot cope adequately with increased stress, they experience physiological, psychological, behavioral, social, and cognitive problems \[7\]. Non-pharmacological methods used to cope with stress include cognitive-behavioral therapies, yoga, breathing exercises, massage, acupressure, and acupuncture. Another method that meets the criteria of accessibility, reliability, cost-effectiveness, and self-applicability among non-pharmacological methods used to cope with experienced stress is ear massage \[8\]. According to Traditional Chinese Medicine, the ear is directly or indirectly connected to twelve meridians, and stimulating the ear restores balance between vital energy (qi) and blood flow yin-yang \[9\]. There are reflex points on these meridians that stimulate internal organs and qi to relieve stress, anxiety, and reduce sleep problems \[10\]. These reflex points are points on the body's surface through which the qi of internal organs and meridians pass. Each point is associated with specific psychological, neurological, and immunological effects to best balance physiological and psychological functions \[11\].

Furthermore, the only peripheral branch of the vagus nerve is in the outer ear. Stimulation of the auricular vagus nerve suppresses the sympathetic nerve and activates the parasympathetic nerve \[12\]. Decreased sympathetic and increased parasympathetic activity helps reduce stress levels and stress-related anxiety by lowering cortisol and epinephrine levels \[13\]. Decreased cortisol levels increase melatonin levels, promoting sleep and relaxation \[14\]. Compared to acupuncture and ear acupressure, ear massage has the advantage of being tool-free and easy to apply. It can also be easily applied by individuals with temporal, spatial, and situational constraints. Since it does not involve any invasive intervention, it has no side effects \[8\].

Due to these features, it has the potential to be widely used by nurses to reduce patients' stress, anxiety, and sleep problems in clinical and field settings, and according to nursing regulations, massage is one of the independent roles of nurses \[15, 16\]. Complementary and alternative treatments involving ear massage are observed to have fewer clinical studies and a lack of scientific evidence compared to modern medicine; therefore, a validation process through scientific research experiments is needed \[12\].

Ear massage is a promising, easily applicable, non-invasive, safe, and cost-effective non-pharmacological method for reducing stress and anxiety symptoms experienced by caregiver family members and increasing sleep quality. However, more evidence is needed regarding the effectiveness of ear massage \[8, 12\]. This study aims to determine the effect of ear massage on stress, anxiety levels, and sleep quality in parents of children diagnosed with Type 1 diabetes \[8\].

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.

Primary outcomes:
measure: Change in Stress Levels
timeFrame: 2 weeks (after intervention)
measure: Change in Anxiety Levels
timeFrame: 2 weeks (after intervention)
measure: Change in Sleep Quality
timeFrame: 2 weeks (after intervention)
Secondary outcomes:
measure: Change in Energy Levels
timeFrame: Every day (for 2 weeks).
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Health Sciences Institute Nursing Department Çiftlikköy Campus Yenişehir / MERSİN TURKEY
Study officials:
References:
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