About this trial
The aim of this study will be to determine the effect of high power laser acupuncture on post menopausal hot flashes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Breast cancer.
Myocardial infarction.
Pulmonary embolism.
Trial design
Parallel
Treatments tested in this trial
High power laser acupuncture
DeviceParticipants 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.
Placebo High power laser acupuncture
Other interventionParticipants 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.
Paced Respiration Exercise
Other interventionAll 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Follicular stimulating hormone analysis
Participants will rest in a semi-recumbent position with proper back and arm support. The antecubital area will be disinfected with alcohol, and approximately 5 cubic centimeters of venous blood will be drawn from the antecubital vein using a sterile disposable syringe. Blood samples will be collected twice, before the start and after completion of the study. All samples will be obtained in the morning before breakfast to ensure standardization.
Sponsors and contacts
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