Hot Water Therapy for the Treatment of Menopause-related Hot Flashes
The purpose of this research is to determine whether hot water therapy (i.e. taking prolonged hot baths on multiple consecutive days) decreases hot flash symptoms and improves mood in women who are undergoing or who have underwent menopause. It is hypothesized that women who undergo hot water therapy will have reduced hot flash symptoms and improved mood.
Initial tracking period: Women who volunteer to participate in this study will be asked to track the frequency and intensity of their hot flash and other menopause-related symptoms for an initial two week period. Afterwards, they will start their heat therapy program.
Physiological assessments: On days 1, 7, and 13 of the heat therapy sessions, the participants will enter a climate controlled room to have their thermoregulatory responses assessed. This will consist of slowly walking on a motorized treadmill in 99.5°F (37.5°C) and 30% relative humidity conditions, for 30 min, after which the humidity in the climate chamber will be progressively increased until their core temperature begins to increase (\~2 hour total time). Before and/or during these trials, core temperature, heart rate, whole-body sweat losses, thermal comfort, local sweat rate, and skin blood flow will be measured, and a 6 ml (\~1 tsp) blood sample will be taken, to assess how the participants respond to the heat stress. These sessions should take less than 3 hours to complete.
Hot water therapy sessions: Upon enrolling in the study, the participants will be assigned to one of two groups: water bathing at 105°F or 97°F in the lab. On days 2-6 and 8-12 of the therapy sessions, the participants will immerse themselves to a water level at the shoulders for \~30 min, followed by immersion to the hip level for \~60 min (total immersion time of 90 min).
Post-intervention tracking period: after completing the heat therapy sessions, the participants will be asked to continue to take baths at home once every 4 days for 1 month. During this time, the participants will be asked to record the intensity and frequency of their hot flashes daily and other menopause-related symptoms weekly. At the end of this month the participants will be given a final exit survey, in order for them to provide the researchers information about their experience participating in the study.
Conditions:
🦠 Menopause
🦠 Menopause Related Conditions
🦠 Menopause Syndrome
🗓️ Study Start (Actual)
1 January 2024
🗓️ Primary Completion (Estimated)
1 May 2025
✅ Study Completion (Estimated)
1 May 2025
👥 Enrollment (Estimated)
100
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Colorado Springs, Colorado, United States
Description
Inclusion Criteria:
- * Self-reported menopause-related hot flashes
Exclusion Criteria:
- * Diagnosed with a cardiovascular illness that precludes them from taking part in exercise
Ages Eligible for Study:
40 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Yes
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
1 December 2023
- First Submitted that Met QC Criteria
20 December 2023
- First Posted
5 January 2024
Study Record Updates
- Last Update Submitted that Met QC Criteria
20 December 2023
- Last Update Posted
5 January 2024
- Last Verified
December 2023