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The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among women

The effect of education-based cognitive-behavioral approach on beliefs, behaviors, and symptoms of hot flashes and insomnia among menopausal transition women: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250120064452N1
Enrollment
128
Registered
2025-04-10
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause, Hot Flash, Insomnia. Menopausal and female climacteric states

Interventions

Intervention 1: Intervention group: Two-hour training sessions, once a week, for six weeks. A cognitive-behavioral approach will be used to structure the content of the sessions, focusing on psychoedu

Sponsors

Gonabad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: Completion of the Informed Consent Form Iranian and a resident of Gonabad city Ability to read and write Menopause transition years (45 to 55 years) In the event of menopause, the menopause must have occurred naturally (not due to surgery) Having hot flashes/night sweats (a score above 2 on the hot flash rating scale) for at least 1 month Having insomnia for at least 1 month

Exclusion criteria

Exclusion criteria: Use of effective medications for hot flashes (Estrogen and Progesterone, SSRIs, and SNRIs, Antihypertensive and Anticonvulsant drugs) Presence of medical or psychological conditions that prevent participation in the study Occurrence of a stressful event in the past six months (as reported by the participant) Specific diet and soy supplements consumption or other plant-based compounds affecting menopausal symptoms, including isoflavone consumption (as reported by the participant) Breast cancer (provided that less than six months have passed since the end of treatment) Presence of medical conditions that may affect hot flashes (as reported by the participant) Use of prescription or over-the-counter treatments for hot flashes in the past 30 days (as reported by the participant) Use of sex steroid hormones or hormonal contraceptives drugs (within the past 2 months) (as reported by the participant) History of treatment or training based on cognitive behavioral therapy

Design outcomes

Primary

MeasureTime frame
Hot flash severity on the Hot Flash Frequency And Problem Rating Scale. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention. Method of measurement: Hot Flash Frequency And Problem Rating Scale.;Hot flash frequency on the Hot Flash Frequency And Problem Rating Scale. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention. Method of measurement: Hot Flash Frequency And Problem Rating Scale.;Insomnia severity on the Insomnia Severity Index. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention. Method of measurement: Insomnia Severity Index.;Night sweats score on Hot Flash Frequency And Problem Rating Scale. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention. Method of measurement: Hot Flash Frequency And Problem Rating Scale.;Hot Flash Behavior score on the Hot Flush Behavior Scale. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and one month after completion of the intervention. Method of measurement: Hot Flush Behavior Scale.;Hot Flash Beliefs Score on the Hot Flash Beliefs Scale. Timepoint: Measuring the severity of hot flashes at the beginning of the intervention (before the start of the intervention), immediately after completion of the intervention, and

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNarjes Bahri Binabaj

Gonabad University of Medical Sciences

nargesbahri@yahoo.com+98 51 5722 3028

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026