Hot Water Therapy for the Treatment of Menopause-related Hot Flashes

NCT06192329 | Withdrawn

• 1 other identifier: 2024-029-HYBL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

heat therapy; hot water therapy; hot water immersion; vasomotor syndrome; hot flashes; hot flushes

Outcome Measures

Primary Outcomes (2)

• Greene climacteric questionnaire

  This is a standard questionnaire used to quantify the intensity of 21 common menopause-related symptoms. The score for each question ranges in intensity from 0 (not at all) to 3 (extremely).

  One month pre therapy through to one month post therapy

• Daily hot flash diary

  Based on industry-standard hot flash diaries, this tracks the number and intensity (where 1 is none and 10 is extreme) of hot flashes, night sweats, and mood disruptions that the participants feel.

  One month pre therapy through to one month post therapy

Secondary Outcomes (6)

• Core temperature

  Day zero, six, and 12 of therapy

• Maximum skin wettedness

  Day zero, six, and 12 of therapy

• Blood plasma volume

  Day zero, six, and 12 of therapy

• Sweat rate

  Day zero, six, and 12 of therapy

• Skin blood flow

  Day zero, six, and 12 of therapy

Other Outcomes (1)

• Exit questionnaire

  One month post therapy

Study Arms (2)

Warm water immersion

SHAM COMPARATOR

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).

Behavioral: Warm water immersion

Hot water immersion

EXPERIMENTAL

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).

Behavioral: Hot water therapy

Interventions

Hot water therapy BEHAVIORAL

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).

Also known as: heat therapy, hot water immersion

Hot water immersion

Warm water immersion BEHAVIORAL

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).

Also known as: Control trial, Sham trial

Warm water immersion

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported menopause-related hot flashes

You may not qualify if:

• Diagnosed with a cardiovascular illness that precludes them from taking part in exercise

Sponsors & Collaborators

• University of Colorado, Colorado Springs: lead
• East Carolina University: collaborator

Study Sites (1)

Hybl Sports Medicine and Performance Center

Colorado Springs, Colorado, 80918, United States

Location

MeSH Terms

Conditions

Hyperthermia; Hot Flashes

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Nathan Morris, PhD

  University of Colorado, Colorado Springs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2025
• Primary Completion: November 19, 2025
• Study Completion: November 19, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)