Effect of Ear Massage on Stress, Anxiety, and Sleep Quality in Parents of Children With Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorMersin University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Effective Ear Massage
BehavioralThe 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 Massage
BehavioralThe 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Effective Ear Massage GroupExperimental treatment 1 intervention
Group B: Sham Ear Massage GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 weeks (after intervention)2
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.
Time frame
2 weeks (after intervention)3
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.
Time frame
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.
Time frame
Every day (for 2 weeks).Sponsors and contacts
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Source ClinicalTrials.gov