TerminatedNot Applicable

Applied Relaxation for Vasomotor Symptoms

Stopped: Low drop-out rate and slow recruitment rate

Sweden60 participantsStarted 2007-03

Plain-language summary

The objectives of this study are to compare frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women treated with applied relaxation (AR) with an untreated control-group (CG) and to investigate if Health Related Quality of Life improve in the AR-group compared to an untreated CG.To study if salivary cortisol excretion would change within the AR treated group compared with the control group.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * postmenopausal women (at least 12 months since last menstrual bleeding occurred or in previously hysterectomised women a serum follicle-stimulating hormone (S-FSH) defined as postmenopausal level according to references at the local laboratory) * More or equal to 7 moderate to severe hot flashes or more or equal at 50 hot flashes per week according to a two-week screening diary * ability to understand and speak Swedish * freely given informed consent Exclusion Criteria: * unstable thyroid or other metabolic disease * treatment with hormone therapy (HT) or other complementary- or alternative treatments treatment for menopausal-related symptoms * treatment with psychopharmacological drugs and/or sedatives d-un-treated psychiatric disease * frequently exercising women (≥ 2h high-intensity activities/week)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hot flashes average number and severity

Timeframe: Baseline to 12 week after "start of treatment"

Trial details

NCT IDNCT01488864

SponsorElizabeth Nedstrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Menopause trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.