StressNCT06829251
Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
A study testing Effective Ear Massage in people with Stress and Anxiety, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Stress, Anxiety, Sleep Quality
- What is being tested?
- Effective Ear Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin University Health Sciences Institute Nursing Department Çiftlikköy Campus Yenişehir / MERSİN TURKEY
Mersin, 33343
Ebru Koç, Master's Nursing, +90 534 820 0162, ebru33koc@gmail.com
About this study
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
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.
Read more
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.
Read the 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].
- Conditions
- Stress, Anxiety, Sleep Quality
- Being tested
- Effective Ear Massage, Sham Ear Massage
- Keywords
- Ear Massage, Stress, Anxiety, Sleep Quality, Tip-1 Diabetes Mellitus, Parents
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective Ear MassageBehavioural
The intervention consists of a structured ear massage technique administered daily for 2 weeks. Parents will receive training on how to target specific pressure points on the ear to reduce stress and anxiety, and improve sleep quality. This training will be conducted via WhatsApp (What's up Application) for 20 minutes, followed by daily massage practice. The massage will be performed using varying pressure over a 3-minute period on the entire ear, focusing on stress and sleep points.
Sham Ear MassageBehavioural
The sham intervention involves a 1-minute ear massage on the outer helix rim, helix crest, and helix points 1, 2, and 3, without applying any pressure. The goal of the sham massage is to mimic the process of ear massage while ensuring no physiological effect on stress, anxiety, or sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Effective Ear Massage Group | Experimental | Parents in this group will receive a 20-minute individual instruction on ear massage via WhatsApp (What's up Application). They will be taught an effective ear massage technique targeting key stress, anxiety, and sleep points. The massage will be performed on the entire ear with varying pressure over a 3-minute period. During the sessions, parents will be assessed using the Readiness for Intervention Form . When the massage starts the day after the interview, parents will fill out the Ear Massage Follow-Up Form , and a reminder message will be sent by the researcher before the scheduled massage time, asking parents to set an alarm on their phones. Additionally, the Ear Massage Training Brochure will be provided. After two weeks, the Depression, Anxiety, Stress Scale-21 (DASS-21) and Pittsburgh Sleep Quality Index will be administered. At the end of the study, parents will be reminded to consider psychiatric clinic consultations. Receives: Behavioral: Effective Ear Massage |
| Sham Ear Massage Group | Sham comparator | Parents in this group will receive 20-minute individual instruction on ear massage via WhatsApp (What's up Application). They will perform a sham ear massage on the helix outer rim,helix crest and points 1, 2, and 3 without applying pressure. This 1-minute sham massage mimics the intervention but does not affect stress, anxiety, or sleep. Parents will be assessed using the Readiness for Intervention Form. The massage will start the day after the interview. Parents will fill out the Ear Massage Follow-Up Form . A reminder will be sent by the researcher before the massage time, asking them to set an alarm. Additionally, the Ear Massage Training Brochure will be provided. After two weeks, the Depression, Anxiety, Stress Scale-21 (DASS-21) and Pittsburgh Sleep Quality Index will be administered. The sham control group will later learn the effective ear massage technique. At the end, parents will be reminded to consider psychiatric consultations. Receives: Behavioral: Sham Ear Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress Levels
Changes in stress levels will be measured at two weeks using the Depression, Anxiety, Stress Scale-21 (DASS-21). Lovibond (1995) developed the original 42-item scale, and the same authors later created the 21-item short form, which was adapted to Turkish culture by Sarıçam (2018). The scale consists of seven items each for evaluating depression, anxiety, and stress. Responses are given on a 4-point Likert scale (0 = Never, 3 = Always). The Cronbach's Alpha coefficients of the scale are 0.87 for depression, 0.85 for anxiety, and 0.81 for stress.
Depression is classified as follows: (0-4) Normal, (5-6) Mild, (7-10) Moderate, (11-13) Severe, (14+) Extremely Severe Depression. Anxiety is classified as: (0-3) Normal, (4-5) Mild, (6-7) Moderate, (8-9) Severe, (10+) Extremely Severe Anxiety. Stress is classified as: (0-7) Normal, (8-9) Mild, (10-12) Moderate, (13-16) Severe, (17+) Extremely Severe Stress.Only the stress and anxiety subscales will be assessed.
Measured: 2 weeks (after intervention)
Change in Anxiety Levels
Changes in anxiety levels will be measured at two weeks using the Depression, Anxiety, Stress Scale-21 (DASS-21). Lovibond (1995) developed the original 42-item scale, and the same authors later created the 21-item short form, which was adapted to Turkish culture by Sarıçam (2018). The scale consists of seven items each for evaluating depression, anxiety, and stress. Responses are given on a 4-point Likert scale (0 = Never, 3 = Always). The Cronbach's Alpha coefficients of the scale are 0.87 for depression, 0.85 for anxiety, and 0.81 for stress. Depression is classified as follows: (0-4) Normal, (5-6) Mild, (7-10) Moderate, (11-13) Severe, (14+) Extremely Severe Depression. Anxiety is classified as: (0-3) Normal, (4-5) Mild, (6-7) Moderate, (8-9) Severe, (10+) Extremely Severe Anxiety. Stress is classified as: (0-7) Normal, (8-9) Mild, (10-12) Moderate, (13-16) Severe, (17+) Extremely Severe Stress.Only the stress and anxiety subscales will be assessed.
Measured: 2 weeks (after intervention)
Change in Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 24-item questionnaire. The Pittsburgh Sleep Quality Index was developed by Buysse et al. in 1989 to assess sleep quality in psychiatric practice and clinical research. The PSQI evaluates sleep quality over the past month. The validity and reliability studies of this scale for the Turkish culture were conducted by Ağargün et al. in 1996, and the Cronbach's alpha reliability coefficient of the scale was found to be 0.80.Nineteen questions are self-reported, and the last 5 questions are answered by a spouse or roommate. Eighteen items are included in the scoring and are grouped into 7 component scores. Each item is rated on a scale of 0-3. The total score ranges from 0-21, with higher scores indicating poorer sleep quality.
Measured: 2 weeks (after intervention)
Secondary outcomes (1)
Change in Energy Levels
Participants' daily energy levels will be assessed using a rating scale of '0 Very Low' to '10 Very High'. Changes in energy levels will be tracked daily and recorded in the massage tracking form to determine the impact of the intervention.
Measured: Every day (for 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start15 Feb 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Koç, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829251
- Sponsor's protocol ID
- MersinU-SBE-EK-01
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Zhang J, Jin Y, Zhang Q. Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Oct 14;2021:3996101. doi: 10.1155/2021/3996101. eCollection 2021.
PubMed 34691214Chen SR, Hou WH, Lai JN, Kwong JSW, Lin PC. Effects of Acupressure on Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2022 Jan;28(1):25-35. doi: 10.1089/jicm.2020.0256.
PubMed 35085025Park S, Park H, Bang YY. The Effects of Auricular Acupressure on Physiological Index, Depression, Anxiety, and Stress for Elders With Hypertension. Holist Nurs Pract. 2023 Jan-Feb 01;37(1):24-33. doi: 10.1097/HNP.0000000000000558.
PubMed 36378089Tseng YT, Chen IH, Lee PH, Lin PC. Effects of auricular acupressure on depression and anxiety in older adult residents of long-term care institutions: A randomized clinical trial. Geriatr Nurs. 2021 Jan-Feb;42(1):205-212. doi: 10.1016/j.gerinurse.2020.08.003. Epub 2020 Sep 11.
PubMed 32921508Cha NH, Park YK, Sok SR. Effects of Auricular Acupressure Therapy on Stress and Sleep Disturbance of Middle-Aged Women in South Korea. Holist Nurs Pract. 2017 Mar/Apr;31(2):102-109. doi: 10.1097/HNP.0000000000000197.
PubMed 28181975Kuo SY, Tsai SH, Chen SL, Tzeng YL. Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-caesarean section women: A single-blind, randomised controlled study. Int J Nurs Stud. 2016 Jan;53:17-26. doi: 10.1016/j.ijnurstu.2015.10.006. Epub 2015 Oct 22.
PubMed 26525188Xin D, Cui L, Wang L, Zhang Q, Chen X, Shi Y, Zhu W, Xu N, Li W, Wang Y. Effect of auricular acupressure on sleep quality in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2024 Nov;57:101876. doi: 10.1016/j.ctcp.2024.101876. Epub 2024 Jun 9.
PubMed 38925078Rechenberg K, Grey M, Sadler L. Stress and Posttraumatic Stress in Mothers of Children With Type 1 Diabetes. J Fam Nurs. 2017 May;23(2):201-225. doi: 10.1177/1074840716687543. Epub 2017 Jan 10.
PubMed 28795899Morrow T, Bhatia SH, Parmar AM, Baker L, Abadula F, Williamson D, Choudhary A, Jaser SS. Sleep Habits of Early School-Aged Children with Type 1 Diabetes and Their Parents: Family Characteristics and Diabetes Management. Behav Sleep Med. 2022 Sep-Oct;20(5):649-658. doi: 10.1080/15402002.2021.1977305. Epub 2021 Sep 24.
PubMed 34559603Bassi G, Mancinelli E, Di Riso D, Salcuni S. Parental Stress, Anxiety and Depression Symptoms Associated with Self-Efficacy in Paediatric Type 1 Diabetes: A Literature Review. Int J Environ Res Public Health. 2020 Dec 28;18(1):152. doi: 10.3390/ijerph18010152.
PubMed 33379307Horsch A, McManus F, Kennedy P, Edge J. Anxiety, depressive, and posttraumatic stress symptoms in mothers of children with type 1 diabetes. J Trauma Stress. 2007 Oct;20(5):881-91. doi: 10.1002/jts.20247.
PubMed 17955536Whittemore R, Jaser S, Chao A, Jang M, Grey M. Psychological experience of parents of children with type 1 diabetes: a systematic mixed-studies review. Diabetes Educ. 2012 Jul-Aug;38(4):562-79. doi: 10.1177/0145721712445216. Epub 2012 May 11.
PubMed 22581804Azimi T, Johnson J, Campbell SM, Montesanti S. Caregiver burden among parents of children with type 1 diabetes: A qualitative scoping review. Heliyon. 2024 Mar 12;10(6):e27539. doi: 10.1016/j.heliyon.2024.e27539. eCollection 2024 Mar 30.
PubMed 38524615
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06829251
- Acronym / sponsor ID
- MersinU-SBE-EK-01
- Conditions
- Stress, Anxiety, Sleep Quality
- Keywords
- Ear Massage, Stress, Anxiety, Sleep Quality, Tip-1 Diabetes Mellitus, Parents
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Effective Ear Massage Group | Experimental | Behavioral: Effective Ear MassageParents in this group will receive a 20-minute individual instruction on ear massage via WhatsApp (What's up Application). They will be taught an effective ear massage technique targeting key stress, anxiety, and sleep points. The massage will be performed on the entire ear with varying pressure over a 3-minute period. During the sessions, parents will be assessed using the Readiness for Intervention Form . When the massage starts the day after the interview, parents will fill out the Ear Massage Follow-Up Form , and a reminder message will be sent by the researcher before the scheduled massage time, asking parents to set an alarm on their phones. Additionally, the Ear Massage Training Brochure will be provided. After two weeks, the Depression, Anxiety, Stress Scale-21 (DASS-21) and Pittsburgh Sleep Quality Index will be administered. At the end of the study, parents will be reminded to consider psychiatric clinic consultations. |
| Sham Ear Massage Group | Sham comparator | Behavioral: Sham Ear MassageParents in this group will receive 20-minute individual instruction on ear massage via WhatsApp (What's up Application). They will perform a sham ear massage on the helix outer rim,helix crest and points 1, 2, and 3 without applying pressure. This 1-minute sham massage mimics the intervention but does not affect stress, anxiety, or sleep. Parents will be assessed using the Readiness for Intervention Form. The massage will start the day after the interview. Parents will fill out the Ear Massage Follow-Up Form . A reminder will be sent by the researcher before the massage time, asking them to set an alarm. Additionally, the Ear Massage Training Brochure will be provided. After two weeks, the Depression, Anxiety, Stress Scale-21 (DASS-21) and Pittsburgh Sleep Quality Index will be administered. The sham control group will later learn the effective ear massage technique. At the end, parents will be reminded to consider psychiatric consultations. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effective Ear MassageThe intervention consists of a structured ear massage technique administered daily for 2 weeks. Parents will receive training on how to target specific pressure points on the ear to reduce stress and anxiety, and improve sleep quality. This training will be conducted via WhatsApp (What's up Application) for 20 minutes, followed by daily massage practice. The massage will be performed using varying pressure over a 3-minute period on the entire ear, focusing on stress and sleep points. | Behavioural | Effective Ear Massage Group |
| Sham Ear MassageThe sham intervention involves a 1-minute ear massage on the outer helix rim, helix crest, and helix points 1, 2, and 3, without applying any pressure. The goal of the sham massage is to mimic the process of ear massage while ensuring no physiological effect on stress, anxiety, or sleep quality. | Behavioural | Sham Ear Massage Group |
Primary outcome
Change in Stress Levels
Time frame: 2 weeks (after intervention)
Changes in stress levels will be measured at two weeks using the Depression, Anxiety, Stress Scale-21 (DASS-21). Lovibond (1995) developed the original 42-item scale, and the same authors later created the 21-item short form, which was adapted to Turkish culture by Sarıçam (2018). The scale consists of seven items each for evaluating depression, anxiety, and stress. Responses are given on a 4-point Likert scale (0 = Never, 3 = Always). The Cronbach's Alpha coefficients of the scale are 0.87 for depression, 0.85 for anxiety, and 0.81 for stress. Depression is classified as follows: (0-4) Normal, (5-6) Mild, (7-10) Moderate, (11-13) Severe, (14+) Extremely Severe Depression. Anxiety is classified as: (0-3) Normal, (4-5) Mild, (6-7) Moderate, (8-9) Severe, (10+) Extremely Severe Anxiety. Stress is classified as: (0-7) Normal, (8-9) Mild, (10-12) Moderate, (13-16) Severe, (17+) Extremely Severe Stress.Only the stress and anxiety subscales will be assessed.
Change in Anxiety Levels
Time frame: 2 weeks (after intervention)
Changes in anxiety levels will be measured at two weeks using the Depression, Anxiety, Stress Scale-21 (DASS-21). Lovibond (1995) developed the original 42-item scale, and the same authors later created the 21-item short form, which was adapted to Turkish culture by Sarıçam (2018). The scale consists of seven items each for evaluating depression, anxiety, and stress. Responses are given on a 4-point Likert scale (0 = Never, 3 = Always). The Cronbach's Alpha coefficients of the scale are 0.87 for depression, 0.85 for anxiety, and 0.81 for stress. Depression is classified as follows: (0-4) Normal, (5-6) Mild, (7-10) Moderate, (11-13) Severe, (14+) Extremely Severe Depression. Anxiety is classified as: (0-3) Normal, (4-5) Mild, (6-7) Moderate, (8-9) Severe, (10+) Extremely Severe Anxiety. Stress is classified as: (0-7) Normal, (8-9) Mild, (10-12) Moderate, (13-16) Severe, (17+) Extremely Severe Stress.Only the stress and anxiety subscales will be assessed.
Change in Sleep Quality
Time frame: 2 weeks (after intervention)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 24-item questionnaire. The Pittsburgh Sleep Quality Index was developed by Buysse et al. in 1989 to assess sleep quality in psychiatric practice and clinical research. The PSQI evaluates sleep quality over the past month. The validity and reliability studies of this scale for the Turkish culture were conducted by Ağargün et al. in 1996, and the Cronbach's alpha reliability coefficient of the scale was found to be 0.80.Nineteen questions are self-reported, and the last 5 questions are answered by a spouse or roommate. Eighteen items are included in the scoring and are grouped into 7 component scores. Each item is rated on a scale of 0-3. The total score ranges from 0-21, with higher scores indicating poorer sleep quality.
1 secondary outcome
Change in Energy Levels
Time frame: Every day (for 2 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 34691214Wang Y, Zhang J, Jin Y, Zhang Q. Auricular Acupressure Therapy for Patients with Cancer with Sleep Disturbance: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2021 Oct 14;2021:3996101. doi: 10.1155/2021/3996101. eCollection 2021.
- Background: PubMed 35085025Chen SR, Hou WH, Lai JN, Kwong JSW, Lin PC. Effects of Acupressure on Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2022 Jan;28(1):25-35. doi: 10.1089/jicm.2020.0256.
- Background: PubMed 36378089Park S, Park H, Bang YY. The Effects of Auricular Acupressure on Physiological Index, Depression, Anxiety, and Stress for Elders With Hypertension. Holist Nurs Pract. 2023 Jan-Feb 01;37(1):24-33. doi: 10.1097/HNP.0000000000000558.
- Background: PubMed 32921508Tseng YT, Chen IH, Lee PH, Lin PC. Effects of auricular acupressure on depression and anxiety in older adult residents of long-term care institutions: A randomized clinical trial. Geriatr Nurs. 2021 Jan-Feb;42(1):205-212. doi: 10.1016/j.gerinurse.2020.08.003. Epub 2020 Sep 11.
- Background: PubMed 28181975Cha NH, Park YK, Sok SR. Effects of Auricular Acupressure Therapy on Stress and Sleep Disturbance of Middle-Aged Women in South Korea. Holist Nurs Pract. 2017 Mar/Apr;31(2):102-109. doi: 10.1097/HNP.0000000000000197.
- Background: PubMed 26525188Kuo SY, Tsai SH, Chen SL, Tzeng YL. Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-caesarean section women: A single-blind, randomised controlled study. Int J Nurs Stud. 2016 Jan;53:17-26. doi: 10.1016/j.ijnurstu.2015.10.006. Epub 2015 Oct 22.
- Background: PubMed 38925078Xin D, Cui L, Wang L, Zhang Q, Chen X, Shi Y, Zhu W, Xu N, Li W, Wang Y. Effect of auricular acupressure on sleep quality in breast cancer patients: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2024 Nov;57:101876. doi: 10.1016/j.ctcp.2024.101876. Epub 2024 Jun 9.
- Background: PubMed 28795899Rechenberg K, Grey M, Sadler L. Stress and Posttraumatic Stress in Mothers of Children With Type 1 Diabetes. J Fam Nurs. 2017 May;23(2):201-225. doi: 10.1177/1074840716687543. Epub 2017 Jan 10.
- Background: PubMed 34559603Morrow T, Bhatia SH, Parmar AM, Baker L, Abadula F, Williamson D, Choudhary A, Jaser SS. Sleep Habits of Early School-Aged Children with Type 1 Diabetes and Their Parents: Family Characteristics and Diabetes Management. Behav Sleep Med. 2022 Sep-Oct;20(5):649-658. doi: 10.1080/15402002.2021.1977305. Epub 2021 Sep 24.
- Background: PubMed 33379307Bassi G, Mancinelli E, Di Riso D, Salcuni S. Parental Stress, Anxiety and Depression Symptoms Associated with Self-Efficacy in Paediatric Type 1 Diabetes: A Literature Review. Int J Environ Res Public Health. 2020 Dec 28;18(1):152. doi: 10.3390/ijerph18010152.
- Background: PubMed 17955536Horsch A, McManus F, Kennedy P, Edge J. Anxiety, depressive, and posttraumatic stress symptoms in mothers of children with type 1 diabetes. J Trauma Stress. 2007 Oct;20(5):881-91. doi: 10.1002/jts.20247.
- Background: PubMed 22581804Whittemore R, Jaser S, Chao A, Jang M, Grey M. Psychological experience of parents of children with type 1 diabetes: a systematic mixed-studies review. Diabetes Educ. 2012 Jul-Aug;38(4):562-79. doi: 10.1177/0145721712445216. Epub 2012 May 11.
- A comprehensive study explaining the pathophysiology, diagnosis, and management of type-1 diabetes.Link provided by the sponsor.
- Link to the Official Gazette Containing Regulations in the Regulation of the Ministry of Health of the Republic of TurkeyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effective Ear Massage in people with Stress and Anxiety, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Koç, Master's Nursing (+90 534 820 01 62, ebru33koc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stress Levels (time frame: 2 weeks (after intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829251, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.