Ear Massage and Sleep Quality in Earthquake-Affected Women

NCT06990789 | Completed

• 1 other identifier: MersinU-SBE-DH-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; Sleep Perception

Keywords

sleep; woman; ear massage; Earthquake

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  two weeks

Study Arms (2)

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.

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.

Behavioral: Sham Comparator

Interventions

effective self-applied ear massage BEHAVIORAL

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.

Intervention group ear massage (effective ear massage)

Sham Comparator BEHAVIORAL

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.

Control (Sham) Group Ear Massage

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Abdulgani Turkmen Konteynerkent

Hatay, DEFNE, 31160, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• OVERALL STUDY OFFİCİALS sümbüle köksoy vayısoğlu, doçent doktor

  Mersin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The women participating in the study will not know which group they belong to. During the statistical analysis of the study, group codes will be designated as A and B, and which code represents which group will be kept in a sealed envelope by a researcher who is not involved in the analysis process. Once all analyses are completed, the group codes will be revealed, thereby enhancing the impartiality and reliability of the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's student

Model Details: two groups with a self-ear massage control group

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: May 25, 2025
• Study Start: June 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 20, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)