Sleep QualityNCT06990789
Ear Massage and Sleep Quality in Earthquake-Affected Women
A study testing effective self-applied ear massage in people with Sleep Quality and Sleep Perception, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The purpose is study is to vestigate the effect of self-administered ear massage on the sleep quality of women affected by the earthquake. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sleep Quality, Sleep Perception
- What is being tested?
- effective self-applied ear massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those with a PSQI score above 5 Women between the ages of 18-65 Those who volunteered to participate in the research and signed an informed form Those residing in Hatay during the earthquake Those who understand Turkish speech Those who have no obstacles to communication
Who cannot join
- Those who do not volunteer to participate in the study Those who experience chronic pain of unknown cause Those who have a disease diagnosed by a doctor (obstructive sleep disorder, psychiatric disorders, dementia, Alzheimer's disease, etc., cancer) Those who are pregnant or suspected of being pregnant Those who use prescription/non-prescription medications for sleep
- Those who are receiving ongoing complementary therapy (e.g. aroma therapy, massage therapy, foot reflexology, yoga and tai chi)
- Those who use food supplements/teas for sleep
- Those with auricular plasia or hypoplasia
- Those who have an active infection or skin integrity disorder in the ear area (ulcer, eczema, urticaria, surgical incision, etc.)
- Those who have responsibilities such as taking care of a baby or the elderly that require waking up at night
- Those who work shift jobs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdulgani Turkmen Konteynerkent
Hatay, DEFNE, 31160
About this study
Official title: Effect of Self-Applied Ear Massage on Sleep Quality of Earthquake-Affected Women
The purpose is study is to vestigate the effect of self-administered ear massage on the sleep quality of women affected by the earthquake.
Read the detailed description
Sleep is a necessary process for the body to renew and maintain functions. Sleep, which begins with the activation of the anterior hypothalamus region in the brain, occurs in two main stages: REM (Rapid Eye Movement) and NREM (Non-Rapid Eye Movement). The REM stage is associated with cognitive functions and memory, while the NREM stage supports cellular renewal and growth. While growth hormone and melatonin increase during sleep, cortisol levels decrease and the body prepares for the new day.
Sleep has a great role in regulating mental and physical health. However, sleep disorders are common in society and are seen in 22-50%. These disorders can lead to serious consequences such as concentration and memory problems, depression, immune weakness, obesity and heart diseases. Traumatic events such as earthquakes in particular trigger sleep problems and negatively affect the quality of life of individuals. Sleep disorders can continue for many years in people affected by earthquakes, and women are at higher risk in this regard.Socioeconomic conditions and psychiatric sensitivity in women contribute to the increased risk of sleep disorders.
Pharmacological and non-pharmacological treatments are used together to eliminate sleep disorders. While pharmacological methods can cause side effects, nonpharmacological approaches are safe and widely preferred. Ear massage, one of the nonpharmacological methods, is an effective intervention that can be applied independently in nursing care. The ear contains an important branch of the vagus nerve, and massage applied to this area activates the parasympathetic nervous system, contributing to stress reduction, balancing cortisol levels, and increasing sleep quality.
Ear massage stands out as an effective and side-effect-free method for individuals experiencing sleep problems after a disaster. It is of critical importance for public health nurses to develop and disseminate such easily applicable approaches, especially in the post-disaster period. Ear massage, which supports general health by stimulating the vagus nerve, offers an important option for improving individuals' sleep patterns and quality of life after traumatic events.
- Conditions
- Sleep Quality, Sleep Perception
- Being tested
- effective self-applied ear massage, Sham Comparator
- Keywords
- sleep, woman, ear massage, Earthquake
- Medical subject headings
- 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 self-applied ear massageBehavioural
The women will be treated for two weeks. It will be applied 7 days a week, in the first hour after waking up in the morning and in the last hour before going to bed at night. Each session will be 3 minutes.
Sham ComparatorBehavioural
The women will be treated for two weeks. It will be applied 7 days a week, in the first hour after waking up in the morning and in the last hour before going to bed at night. Each session will be 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group ear massage (effective ear massage) | Active comparator | self ear massage will be applied to individuals starting from the endocrine point and occiput point located in the frontal lobe of the ear, massage is done to the heart, shenmen and sympathy points. Receives: Behavioral: effective self-applied ear massage |
| Control (Sham) Group Ear Massage | Sham comparator | It will be applied to the five points called helix 1,2,3,4,5 located on the auricle. Care will be taken not to create pressure and a stroking movement will be made. Receives: Behavioral: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQI
PSQI is a 19-item questionnaire to measure sleep quality, with a total score ranging from 0 to 21; lower scores indicate better sleep quality.
Measured: Pre-test phase and 4 weeks after the post-test
Xiaomi Smart Band 9
It is planned to objectively measure sleep quality using the Xiaomi Smart Band 9 device. Xiaomi Smart Band 9, a small and portable device usually worn on the wrist, provides information about sleep-wake cycles by recording the user's movements. The data collected includes information such as sleep duration, time to fall asleep, night wakings, etc. Thus, objective and reliable data are obtained about individuals' sleep quality, daily activity levels and sleep patterns.
Measured: 4 weeks (Pre-test phase, intervention phase, and post-test phase)
pre-sleep arousal scale
The scale, which was developed to assess cognitive and somatic arousal levels in the pre-sleep phase, consists of 16 items and has two sub-dimensions assessing cognitive and somatic arousal before sleep. The items are rated on a 5-point Likert-type scale ranging from 1 (not at all) to 5 (very much). High scores obtained from the scale indicate high arousal.
Measured: Pre-test phase and 4 weeks after the post-test
readiness assessment form
This form includes the ear massage steps and was prepared to evaluate whether the participants performed the ear massage as intended at the end of the training.
Measured: pre-test phase
Massage Application Tracking Form
Participants are asked to indicate the date and time of their ear massage twice a day for 14 days and whether they applied it or not.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start30 Jun 2025
- Primary completion30 Sep 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies 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
- two groups with a self-ear massage control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Harbalioğlu, Mersin University
- Investigators
- OVERALL STUDY OFFİCİALS sümbüle köksoy vayısoğlu, doçent doktor, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990789
- Sponsor's protocol ID
- MersinU-SBE-DH-01
- Status last verified
- Dec 2025
- First submitted
- 17 May 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temel, A. B. (2022). Sağlığı koruma ve geliştirmede uyku sağlığı ve uyku hijyeni. In A. B. Temel (Ed.), Sağlığı koruma ve geliştirme (ss. 94-98). Ankara: Ema Tıp Kitabevi.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Applied Ear Massage on Sleep Quality of Earthquake-Affected Women
- ClinicalTrials.gov ID
- NCT06990789
- Acronym / sponsor ID
- MersinU-SBE-DH-01
- Conditions
- Sleep Quality, Sleep Perception
- Keywords
- sleep, woman, ear massage, Earthquake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 25 May 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 is study is to vestigate the effect of self-administered ear massage on the sleep quality of women affected by the earthquake.
Detailed description
Sleep is a necessary process for the body to renew and maintain functions. Sleep, which begins with the activation of the anterior hypothalamus region in the brain, occurs in two main stages: REM (Rapid Eye Movement) and NREM (Non-Rapid Eye Movement). The REM stage is associated with cognitive functions and memory, while the NREM stage supports cellular renewal and growth. While growth hormone and melatonin increase during sleep, cortisol levels decrease and the body prepares for the new day.
Sleep has a great role in regulating mental and physical health. However, sleep disorders are common in society and are seen in 22-50%. These disorders can lead to serious consequences such as concentration and memory problems, depression, immune weakness, obesity and heart diseases. Traumatic events such as earthquakes in particular trigger sleep problems and negatively affect the quality of life of individuals. Sleep disorders can continue for many years in people affected by earthquakes, and women are at higher risk in this regard.Socioeconomic conditions and psychiatric sensitivity in women contribute to the increased risk of sleep disorders.
Pharmacological and non-pharmacological treatments are used together to eliminate sleep disorders. While pharmacological methods can cause side effects, nonpharmacological approaches are safe and widely preferred. Ear massage, one of the nonpharmacological methods, is an effective intervention that can be applied independently in nursing care. The ear contains an important branch of the vagus nerve, and massage applied to this area activates the parasympathetic nervous system, contributing to stress reduction, balancing cortisol levels, and increasing sleep quality.
Ear massage stands out as an effective and side-effect-free method for individuals experiencing sleep problems after a disaster. It is of critical importance for public health nurses to develop and disseminate such easily applicable approaches, especially in the post-disaster period. Ear massage, which supports general health by stimulating the vagus nerve, offers an important option for improving individuals' sleep patterns and quality of life after traumatic events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups with a self-ear massage control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group ear massage (effective ear massage) | Active comparator | Behavioral: effective self-applied ear massageself ear massage will be applied to individuals starting from the endocrine point and occiput point located in the frontal lobe of the ear, massage is done to the heart, shenmen and sympathy points. |
| Control (Sham) Group Ear Massage | Sham comparator | Behavioral: Sham ComparatorIt will be applied to the five points called helix 1,2,3,4,5 located on the auricle. Care will be taken not to create pressure and a stroking movement will be made. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those with a PSQI score above 5 Women between the ages of 18-65 Those who volunteered to participate in the research and signed an informed form Those residing in Hatay during the earthquake Those who understand Turkish speech Those who have no obstacles to communication
Key exclusion criteria (7 listed)
- Those who do not volunteer to participate in the study Those who experience chronic pain of unknown cause Those who have a disease diagnosed by a doctor (obstructive sleep disorder, psychiatric disorders, dementia, Alzheimer's disease, etc., cancer) Those who are pregnant or suspected of being pregnant Those who use prescription/non-prescription medications for sleep
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 self-applied ear massageThe women will be treated for two weeks. It will be applied 7 days a week, in the first hour after waking up in the morning and in the last hour before going to bed at night. Each session will be 3 minutes. | Behavioural | Intervention group ear massage (effective ear massage) |
| Sham ComparatorThe women will be treated for two weeks. It will be applied 7 days a week, in the first hour after waking up in the morning and in the last hour before going to bed at night. Each session will be 3 minutes. | Behavioural | Control (Sham) Group Ear Massage |
Primary outcome
PSQI
Time frame: Pre-test phase and 4 weeks after the post-test
PSQI is a 19-item questionnaire to measure sleep quality, with a total score ranging from 0 to 21; lower scores indicate better sleep quality.
Xiaomi Smart Band 9
Time frame: 4 weeks (Pre-test phase, intervention phase, and post-test phase)
It is planned to objectively measure sleep quality using the Xiaomi Smart Band 9 device. Xiaomi Smart Band 9, a small and portable device usually worn on the wrist, provides information about sleep-wake cycles by recording the user's movements. The data collected includes information such as sleep duration, time to fall asleep, night wakings, etc. Thus, objective and reliable data are obtained about individuals' sleep quality, daily activity levels and sleep patterns.
pre-sleep arousal scale
Time frame: Pre-test phase and 4 weeks after the post-test
The scale, which was developed to assess cognitive and somatic arousal levels in the pre-sleep phase, consists of 16 items and has two sub-dimensions assessing cognitive and somatic arousal before sleep. The items are rated on a 5-point Likert-type scale ranging from 1 (not at all) to 5 (very much). High scores obtained from the scale indicate high arousal.
readiness assessment form
Time frame: pre-test phase
This form includes the ear massage steps and was prepared to evaluate whether the participants performed the ear massage as intended at the end of the training.
Massage Application Tracking Form
Time frame: two weeks
Participants are asked to indicate the date and time of their ear massage twice a day for 14 days and whether they applied it or not.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publicationTemel, A. B. (2022). Sağlığı koruma ve geliştirmede uyku sağlığı ve uyku hijyeni. In A. B. Temel (Ed.), Sağlığı koruma ve geliştirme (ss. 94-98). Ankara: Ema Tıp Kitabevi.
- 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. This study is not recruiting at the moment.
OVERALL STUDY OFFİCİALS sümbüle köksoy vayısoğlu, doçent doktor study director
Mersin University
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 self-applied ear massage in people with Sleep Quality and Sleep Perception, 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 6 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI (time frame: Pre-test phase and 4 weeks after the post-test). The study lists 5 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 NCT06990789, which also lists 1 linked publication.
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 6 Jan 2026.