Effect of Sleep Hygiene Education on Comfort and Sleep Quality in Menopausal Women

What this trial studies

The decrease in estrogen levels in the body during menopause can lead to sleep disturbances by disrupting serotonin metabolism, which plays an important role in regular sleep. Considering the increase in life expectancy, the duration of time women will spend in menopause is also increasing, making the understanding of menopause physiology and potential management strategies highly important for women's health. One of the most important factors in managing insomnia is sleep hygiene. Sleep hygiene is defined as the principles and practices that improve sleep quality.

Conditions in scope

• Women in the Menopausal Period

Interventions

• Sleep Hygiene Training (Other) — Written consent will be obtained from the women, and a Personal Information Form will be applied. The General Comfort Scale (GCS) will be applied to the women. The Pittsburgh Sleep Quality Index (PSQI) will be applied to the women. Each…

Who can join

Women only · Ages 40 Years to 50 Years

Inclusion criteria

• Voluntarily agree to participate in the study, Are literate, Are open to communication and cooperation, Score 5 or higher on the Pittsburgh Sleep Quality Index (PSQI), Have a Body Mass Index (BMI) lower than 30 kg/m², Have one or more of the following symptoms: vasomotor symptoms such as hot flashes and night sweats, menstrual irregularities, vaginal dryness, urinary incontinence, or sleep disturbances, Are in the premenopausal period and have consulted the gynecology outpatient clinic.

Exclusion criteria

• Diagnosed with a sleep disorder, Have a chronic illness, Are undergoing hormone replacement therapy, Use sleep-related medications such as melatonin, benzodiazepines, antihistamines, and barbiturates, Use alcohol or cigarettes.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2025-02-01
• Primary completion: 2025-10-01
• Last update posted: 2026-04-13
• First posted: 2025-03-19

Sponsor & contact

Lead sponsor: Saglik Bilimleri Universitesi (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• General Comfort Scale (GCS) (Through study completion, an average of 6 months)
  The General Comfort Scale was developed by Kolcaba in 1992. It is used to assess the increase in comfort expected from nursing interventions that promote comfort by identifying individual needs. The scale is a four-point Likert type and contains a total of 48 items. The scale consists of both positive and negative items, with the response patterns mixed. In this…
• Pittsburgh Sleep Quality Index (PSQI) (Through study completion, an average of 6 months)
  The PSQI was developed by Buysse and colleagues in 1989. The validity and reliability study of the PSQI was conducted by Ağargün and colleagues in 1996, and the Cronbach Alpha value was calculated to be 0.79. The PSQI is a self-report scale that evaluates sleep quality and disturbances over a one-month period. The scale consists of seven subcomponents: subjective sleep…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.