Clinical trial NCT06990789: Ear Massage and Sleep Quality in Earthquake-Affected Women
Official title: Effect of Self-Applied Ear Massage on Sleep Quality of Earthquake-Affected Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Quality
Sleep Perception
Keywords: sleep
woman
ear massage
Earthquake
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with a self-ear massage control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PSQI
timeFrame: Pre-test phase and 4 weeks after the post-test
measure: Xiaomi Smart Band 9
timeFrame: 4 weeks (Pre-test phase, intervention phase, and post-test phase)
measure: pre-sleep arousal scale
timeFrame: Pre-test phase and 4 weeks after the post-test
measure: readiness assessment form
timeFrame: pre-test phase
measure: Massage Application Tracking Form
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Abdulgani Turkmen Konteynerkent
state: Defne
Study officials:
affiliation: mersin üniversitesi
name: OVERALL STUDY OFFİCİALS sümbüle köksoy vayısoğlu, doçent doktor
role: STUDY_DIRECTOR
References:
citation: 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.