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Behavioral Intervention
Hot Water Therapy for Menopause-Related Hot Flashes
N/A
Recruiting
Led By Nathan Morris, PhD
Research Sponsored by University of Colorado, Colorado Springs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Diagnosed with a cardiovascular illness that precludes them from taking part in exercise
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month pre therapy through to one month post therapy
Summary
This trial is studying the effects of hot water therapy on menopausal women. The researchers want to see if taking hot baths for multiple days in a row can reduce hot flash symptoms and improve mood.
Who is the study for?
This trial is for women experiencing menopause and suffering from hot flashes. Participants will track their symptoms, undergo heat therapy sessions in a lab, and continue baths at home. Women with certain health conditions that could be worsened by heat or who cannot commit to the study schedule may not qualify.
What is being tested?
The study tests if hot water therapy can reduce hot flash symptoms and improve mood in menopausal women. It involves initial symptom tracking, controlled heat stress tests in a lab setting, followed by regular bathing sessions at two different temperatures.
What are the potential side effects?
Potential side effects might include discomfort due to prolonged exposure to high temperatures such as lightheadedness, dehydration or overheating during the bath sessions and climate-controlled assessments.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart condition that prevents me from exercising.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month post therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month post therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Daily hot flash diary
Greene climacteric questionnaire
Secondary study objectives
Blood plasma volume
Core temperature
Maximum skin wettedness
+3 moreOther study objectives
Exit questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hot water immersionExperimental Treatment1 Intervention
On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 105°F water for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min).
Group II: Warm water immersionPlacebo Group1 Intervention
On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves up to the shoulder in 97°F water for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min).
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Who is running the clinical trial?
University of Colorado, Colorado SpringsLead Sponsor
18 Previous Clinical Trials
5,279 Total Patients Enrolled
East Carolina UniversityOTHER
109 Previous Clinical Trials
39,083 Total Patients Enrolled
Nathan Morris, PhDPrincipal InvestigatorUniversity of Colorado, Colorado Springs
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