NCT07695051

Brief Summary

This randomized controlled trial aims to evaluate the effect of a 6-week cold shower therapy on hot flashes and night sweats in menopausal women. Participants will be randomly assigned to either a cold shower therapy group or a control group. The primary outcome is the change in the frequency and severity of hot flashes and night sweats after the 6-week intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

menopausehot flashesnight sweatscold shower therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Hot Flash and Night Sweat Frequency and Severity

    Change in the frequency and severity of hot flashes and night sweats measured at baseline, week 3 and week 6.

    Baseline, Week 3, Week 6

Study Arms (2)

Cold Shower Therapy

EXPERIMENTAL

Participants received cold shower therapy for 6 weeks.

Behavioral: Cold Shower Therapy

Control

NO INTERVENTION

Participants received routine care and no cold shower therapy during the study period.

Interventions

Participants in the intervention group received daily cold shower therapy for 6 weeks. Water temperature was maintained at 15-20°C using a thermometer provided to participants. The control group received routine care without cold shower therapy. Outcomes were assessed at baseline and after 6 weeks.

Cold Shower Therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to read, write, and understand the study procedures.
  • Women aged 40-65 years.
  • Postmenopausal women experiencing hot flashes and/or night sweats.
  • Not receiving hormone replacement therapy (HRT) for vasomotor symptoms.
  • No known medical contraindication to cold shower therapy.
  • Willing to participate and able to provide written informed consent.

You may not qualify if:

  • History of serious chronic diseases that may affect hemodynamic stability (e.g., cardiovascular disease, uncontrolled hypertension, renal failure, or liver failure).
  • Current use of antidepressant or antipsychotic medications, or diagnosis of a severe psychiatric disorder.
  • Regular use of cold shower or cold-water therapy before enrollment.
  • Incomplete completion of study questionnaires or data collection forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buyukada Central Family Health Center, Unit 001

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nuran Gencturk, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the cold shower therapy group or the control group and followed in parallel for 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Istanbul University - Cerrahpasa

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

January 30, 2026

Primary Completion

July 7, 2026

Study Completion

July 7, 2026

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations