Effect of High Power Laser Acupuncture on Post Menopausal Hot Flashes

NCT07419542 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005136
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Patient reported hot flashes questionnaire

  It will be used to determine the level of the hot flashes for each post menopausal women before starting as well as after the end of the study. Patient reported hot flashes questionnaire used to measure hot flashes frequency during the day and night .Hot flashes questionnaire score ranged from 0 (Not at all) to 10(very much). The numbers from 0 to 10 indicate the average amount of hot flashes which bothers the patient. This questionnaire include questions about number of hot flashes during day, number of hot flashes during night and duration of single hot flashes episode.

  4 weeks

Secondary Outcomes (1)

• Follicular stimulating hormone analysis

  4 weeks

Study Arms (2)

High power laser acupuncture + Paced respiration exercise

EXPERIMENTAL

This group will consist of 30 postmenopausal women, who will receive High power laser acupuncture and paced respiration exercise for 15 minutes/sessions, 3 times/week for 4 weeks.

Device: High power laser acupuncture; Other: Paced Respiration Exercise

Placebo High power laser acupuncture + Paced respiration exercise

PLACEBO COMPARATOR

This group will consist of 30 post menopausal women, who will receive placebo High power laser acupuncture and paced respiration exercise for 15 minutes /sessions, 3 times/ week for 4 weeks.

Other: Placebo High power laser acupuncture; Other: Paced Respiration Exercise

Interventions

Placebo High power laser acupuncture OTHER

Participants assigned to the placebo group will receive sham high-power laser therapy following the same treatment protocol used in the active intervention group, including identical positioning, probe placement, session duration, and frequency. The laser device will appear operational; however, it will be switched off during application and will not emit therapeutic laser energy. Sessions will last 15 minutes, three times per week, for four consecutive weeks.

Placebo High power laser acupuncture + Paced respiration exercise

Paced Respiration Exercise OTHER

All participants in both groups will perform paced respiration exercises during each treatment session. The exercise will consist of slow, controlled breathing at a predetermined rhythm, emphasizing diaphragmatic inhalation and prolonged exhalation. Breathing cycles will be guided verbally or by timing cues to maintain a consistent rate throughout the 15-minute session. The exercise will be performed three times per week for four consecutive weeks under supervision.

High power laser acupuncture + Paced respiration exercise; Placebo High power laser acupuncture + Paced respiration exercise

High power laser acupuncture DEVICE

Participants will lie supine while receiving high-power laser therapy (1064 nm wavelength, 150 mJ max pulse energy, 6 W average power, 760 mJ/cm² frequency, \<150 ms pulse duration). A pulsed waveform (5000 W/cm², 1 W output, 0.2 cm² spot size) will be applied perpendicularly to acupuncture points for 30 s (×3), totaling 15 min/session. Sessions: 3×/week for 4 weeks. Paced respiration exercises will also be performed for 15 min/session over the same period.

High power laser acupuncture + Paced respiration exercise

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sixty post menopausal women suffering from hot flashes.
• Their age will range from 50 to 60 years.
• Their body mass index (BMI) will range(\> 30kg/m2).

You may not qualify if:

• Breast cancer.
• Myocardial infarction.
• Pulmonary embolism.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El Agoza police hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soheir Mahmoud El-Kosery, PhD

  Professor, Cairo University

  STUDY CHAIR

• Mohamed Fawzy Abu-Elenin, PhD

  Consultant

  STUDY DIRECTOR

Central Study Contacts

Eman Saeed Mohamed Elgohary, M.Sc

CONTACT

+20 11 55883130; emanelgohary1982@icloud.com

Soheir Mahmoud El-Kosery, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 20, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 30, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

EG (1)