Ear Massage and Sleep Quality in Earthquake-Affected Women

Not Applicable

Not yet recruiting

• Conditions: Sleep Quality; Sleep Perception

• Registration Number: NCT06990789
• Lead Sponsor: Mersin University

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.

Study Timeline

• Study First Submitted: 2025-05-17
• Study First Submitted QC: 2025-05-17
• Study First Posted: 2025-05-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-22
• Study Start: 2025-07-30
• Primary Completion: 2025-07-30
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PSQI	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	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	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	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	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.

Trial Locations

Locations (1)

Abdulgani Turkmen Konteynerkent; 🇹🇷 Hatay, Defne, Turkey